Different kinds of subutex

Contents

Subutex vs Suboxone

Suboxone and Subutex, both of which were approved by the FDA in 2002, are drugs developed for the treatment of opiate addiction. Prior to 2000 when the Drug Addiction Treatment Act was passed, the primary medication to treat opiate addictions was methadone. In 2000, however, burprenorphine was approved in the law, and it could be prescribed by physicians who have been trained and certified by the Center for Substance Abuse Treatment to treat opioid addiction.

While methadone is a Schedule II substance, buprenorphine is a Schedule III substance, denoting it as a drug with a lower potential for abuse. As a result, burprenorphine is often considered to be a safer opiate treatment medication than methadone. According to the Drug Enforcement Agency, almost 16,000 physicians were certified to prescribe buprenorphine-based products, like Suboxone and Subutex, in 2013. In 2012, 9.3 million prescriptions were written for these medications.

What Is Buprenorphine?

Buprenorphine was previously used as a pain reliever. It is a partial opioid antagonist that binds with opioid receptors in the brain, causing reduced pain and feelings of wellbeing. While buprenorphine isn’t a full opioid, it acts much like one, causing moderate receptor site activity, except it does not create a euphoric state, when taken as directed. As a result, buprenorphine will prevent withdrawal symptoms from, and reduce cravings for, opiate drugs like heroin and prescription painkillers.

There are several advantages to using a medication like buprenorphine in the treatment of opiate abuse. Buprenorphine can:

  • Help the individual to remain safe and comfortable during detox
  • Reduce or eliminate cravings for heroin or other opiates
  • Minimize relapse since the individual is not experiencing uncomfortable withdrawal symptoms
  • Allow the individual to focus on therapy without being distracted by withdrawal symptoms and cravings

What’s the Difference between Subutex and Suboxone?

Both Subutex and Suboxone contain buprenorphine. While both drugs were developed at around the same time, Subutex was formulated first. While it was found to be relatively effective in the treatment of opiate addiction, there was still a tendency to abuse the drug. Many users sought to inject the drug intravenously in order to obtain the high they had become accustomed to with heroin or prescription painkillers. They often succeeded in doing so, giving rise to the need to develop another drug to address this issue: Suboxone.

Suboxone contains both buprenorphine and naloxone, whereas Subutex contains only buprenorphine.

Naloxone is an opioid antagonist, which means that it blocks the effects of opioids at the receptor sites. Naloxone was combined with buprenorphine to deter abuse of the medication. If someone injects Suboxone, the person will immediately go into precipitated withdrawal, which can be distressing.

Which Is Better?

As with any medication, these drugs have potential side effects, including:

  • Constipation
  • Dizziness
  • Drowsiness
  • Headaches
  • Nausea

In comparing Subutex and Suboxone, there is little evidence suggesting that either medication is more effective in treating opiate addiction. If both medications are used according to prescription, under medical supervision, the buprenorphine in each will work as it should, mitigating opiate withdrawal symptoms and reducing cravings.

The main difference between Subutex and Suboxone is in regard to their abuse potential. Due to the presence of naloxone, Suboxone may be less likely to be abused. As a result, this may be the best choice for those suffering from severe addictions or those who have been through treatment before and relapsed.

Suboxone and Subutex should be used as part of a greater addiction treatment program. Medication alone does not constitute addiction treatment; it should be used alongside comprehensive therapy that addresses the root causes that led to the initial substance abuse. It’s not enough to address the physical aspect of opiate addiction, as Suboxone and Subutex do. The psychological aspects of addiction must be dealt with in therapy, ensuring a person’s sustained recovery from the disease.

Subutex Pills

First and foremost, what is Subutex? What is it used for?

Subutex is a brand name of the generic buprenorphine, which is used to treat opioid dependence. Opioids are prescription drugs that include things like oxycodone, as well as the illicit street drug heroin.

The U.S. is currently in the midst of a severe opioid epidemic, and drugs like Subutex are being relied upon to help users move away from their addiction to opioids. In some cases, Subutex or buprenorphine may be used for other reasons, such as a pain reliever, but this is less common.

The active ingredient of Subutex, which is buprenorphine, is known as an opioid partial agonist. This means that it interacts with the same receptors in the brain as opioids do, but it doesn’t cause people to feel the high that these drugs would. When you take Subutex, the theory is that you don’t experience the cravings for opioids that you would otherwise.

It’s essentially a way to trick your brain into thinking you’ve been exposed to opioids, which can help prevent withdrawal symptoms.

Withdrawal symptoms occur because your body has become physically dependent on the presence of opioids to bind to these certain central nervous system receptors. When the opioids aren’t present on the receptors, it sends your body into a type of shock. This can cause a variety of physical and psychological symptoms, which make it difficult to stop using opioids.

What happens when Subutex is taken is that it binds to these certain receptors, but without allowing for the euphoric effects of other drugs. If you were to take another opioid, the buprenorphine wouldn’t let it bind to these receptors.

Since buprenorphine is a partial agonist, it means it can’t activate opioid receptors enough to create euphoria. It’s also unlikely that buprenorphine would slow respiration enough to lead to an overdose, as commonly happens with opioids.

There are two drugs that are often confused with one another, which are Subutex and Suboxone. Subutex is different from Suboxone because it contains only one active ingredient: buprenorphine. Suboxone, on the other hand, contains both buprenorphine and something else called naloxone, which is added to help prevent abuse of the medicine.

PMC

Discussion

Buprenorphine is one of the non-injectable drugs most diverted by drug users. Per os, buprenorphine undergoes an intense first-pass hepatic metabolism that is responsible for a bioavailability of approximately 20%. The absolute sublingual bioavailability of buprenorphine can reach 30% to 55%, depending on subjects . A self-injecting drug significantly increases the administered doses, and therefore increases felt effects but also the involved risks. In France, the risk reduction policy associated to drug consumption by injectable route showed its value in the reduction of overdose death prevalence and of infectious diseases (HIV, CHV…). The main actions that were taken over the last 30 years were based on reducing the infectious risk, through authorizing over-the-counter syringe sales in pharmacies, and then through providing prevention kits (Steribox). These devices have evolved depending on the epidemics that the drug users were facing: VIH, HBV and HCV. Beyond the infectious risk, other worrying problems are associated to insoluble particles injection: phlebitis, pulmonary embolisms, ” puffy hand ” syndrom … –. In order to prevent these complications from occurring, filtrating the injected solutions has become necessary. After the end of the 90s, different types of filters have been provided for users – sterile cotton filters available in the Steribox and the Sterifilt which were provided in the Reception and Harm Reduction Support Centres for drug users (CAARUD), and in other low demand threshold structures or harm reduction structures. The cotton filters are relatively easy to use, but they present 2 major drawbacks: they let through big particles in the solution (possibly cotton fibres), and present an important void volume, which causes a substance loss leading to an increased filter misuse (selling, sharing, reusing, ” squeezing “). As the Sterifilt presents a 10 µm cut-off, they retain the majority of big particles and have a very low dead volume, but are more difficult to use. Determining buprenorphine ” extractability ” had up to now never been studied in real use conditions. The quantity of buprenorphine retained by the cotton filters is superior to that of Sterifilt, translating in fine into an inferior injected doses (after cotton-pad filtration), compared to Sterifilt. These results can be compared to those obtained with heroin . However, buprenorphine is an excellent candidate to injection since whatever the filtration conditions may be, at least 70% of the dosis is retrieved and can therefore be injected. The main question we have wanted to answer is the origin of the cutaneous necrotic lesions, mainly livedo-like dermatitis (LLD), observed almost exclusively during the injection of the generic . Presently, LLD pathogenesis has not completely been solved. The first cases of Nicolau syndrom occurred after intramuscular injection of bismuth salt for the treatment of syphilis dates back to the twentieth century . Most of cases of LLD have been reported after intramuscular injection of non steroidal anti-inflammatory, antibiotic (penicillin, aminoglycosides) or glucocorticoids drugs, and more recently by self injection of etanercept –. Therefore, these necrotic skin lesions always appear after an injection (arterial, peri-arterial or peri-nervous), and are variably associated with a necrosis and/or embolism/ischemia –. Three reports of LLDs after buprenorphine injection have been previously reported and confirmed by histological findings –. All cases took place in the context of intra-arterial injection. Skin biopsies showed extravascular or intravascular foreign bodies associated with inflammatory infiltrates. The features of these foreign bodies were typical of starch particles. Recently, Hornez et al. reported a rare case of a necrosis of the penis glans occurred after buprenorphine subcutaneous injection, and showed that ischemia was like a chemical burn with various levels of lesions and was also related to starch . Potier et al. identified two main mechanisms involved in the origin of necrotic LLD: embolization of starch particles and ulcerations related to chronic dermohypodermic inflammation . Schneider et al. also reported that livedoid and necrotic skin lesions were likely due to the thrombosis caused by the excipients and that local endothelial inflammation contributed to the lesions . These results are consistent with the skin biopsy of the patient depicted in figure 1: dermatologists identified necrotic lesion, and biopsy reveals thrombosis, perivascular inflammation, non-organic refringent particles and particles containing silica. The main hypothesis is that a vascular mechanism could be involved. In this physiopathological context, we have oriented our research towards the detection of particles potentially present in the solutions that drug users can self-inject. Because standard anatomy and physiology textbooks report that the minimum capillary lumen measures between 4 and 8 µm in diameter , , the 4.2 µm limit has been chosen so to highlight only the particles that are capable of blocking human micro capillaries. Moreover, this cut-off is in accordance with the European Pharmacopeia concerning injectable preparations. Detecting these particles in the various tested solutions is not easy. Indeed, although the different pharmacopeia (European, American…) precisely describes which controls should be performed on active substances and on certain excipients, these recommended techniques cannot be used in the context of our study. In aqueous solutions, granulometric studies require important dilution; for this work, the solutions had to be diluted in a final volume of 125 mL. This obligation causes reduced sensibility, which explains the absence of results for the SFS condition (figure 3A). That is why we have diverted the flow cytometry from its usual application, in order to study the number of particles and their size range. Combining these 2 approaches allowed us to apprehend the distribution of insoluble particles. The total number of particles is systematically higher with the generic (figure 3B) with a majority of particle size <10 µm for the generic solution and >10 µm for the Subutex solutions whatever the size and the filtration type. These results are in accordance with the work of Roux et al. which assessed the efficiency of the Sterifilt . The second step of this work was to identify the nature of the particles in solution. Although the infrared spectroscopy and the scanning electronic microscopy are reference techniques, the nature of solutions makes it impossible to exploit the results. The main obstacle is due to the large amount of corn starch present is both drugs. In aqueous solution, this excipient transforms into a opaque and viscous colloidal solution, called starch dressing, which crystallizes after it has dried and covers the other particles, which makes it hard or even impossible to interpret the analyses. In order to eliminate corn starch, the solutions were diluted before being filtered on a 0.22 µm membrane, thus enabling the retention of insoluble particles only. Under these analytical conditions, the difference in appearance of the insoluble particles retained on the filtration membrane is obvious. The generic particles size and heterogeneous shape contrast with the Subutex particle’s homogeneity. This characteristic is present both before and after cotton filtration (figure 4). This difference is even stronger when we take a look at the filtrating membrane pore visibility: they are almost completely blocked by the insoluble particles present in the CFG solutions, whereas they are apparent with the CFS solutions (figure 4E versus 4J, dashed line circle). These results confirm the data obtained by flow cytometry and by laser granulometry: the CFG condition presents a larger proportion of particles which size is inferior to 4.2 µm than the CFS condition. The heterogeneity of these particles is also apparent on SEM images of the section surface of an untampered tablet, that is to say, before any ” misuse ” has occurred. The SEM data obtained after Sterifilt filtration are not displayed because they are not exploitable given how extremely rare the apparent particles are on the filtration membrane surface. Therefore, after having diluted a buprenorphine tablet, only the Sterifilt seems to be capable of retaining the whole of insoluble particles, even when their size is inferior to the filter sieve. The presence of particles with extreme sizes is not found in SEM, whereas laser granulometry and flow cytometry both highlight particles which size is superior to 10 µm. This discrepancy is probably linked to the detection systems, which use light diffraction (laser granulometry and flow cytometry). These techniques cannot establish a distinction between a small particles aggregate and a sole particle. Indeed, the presence of large particles under the cotton filtration conditions is probably due to this limitation. However, should we consider this aggregation as artefactual or as ” physiological ” ? Several arguments seem to strengthen the reality of these aggregates.

In the first place, the insoluble excipients used in the generic are particles that bear many apolar groups on their surface. In aqueous solution, when 2 particles’ surfaces meet, the water separing them is ejected, making it easier for particles to aggregate. This physico-chemical property enables us to explain why particles for which size is inferior to 10 µm, are retained by the Sterifilt, since the main part of the filtration membrane pores are free (as confirmed by SFG solutions). After cotton filtration, the aggregates are not retained and pass through: they can be seen on the filtration membrane (Figure 4). The dashed line circles on the figure 4 show the filtration membrane pores blocked for CFG (figure 4J) whereas they are free for the CFS condition (figure 4E). The second argument that confirms the reality of these aggregates is about the experimental design used for flow cytometry. The samples analyzed by this technique are the closest to reality: the CF sample analysis only required a very small additional dilution. Therefore, it is very likely that the biggest particles highlighted by flow cytometry correspond in fact to aggregated particles. The last step of this work is about analyzing the nature of insoluble particles that were not retained in the cotton filter. We were expecting to highlight the following chemical elements: magnesium for Subutex, silica and magnesium for the generic. The spectral analysis did not bring out the presence of magnesium is the insoluble particles visualized in the CFG and CFS conditions. This result is probably related to the small quantity present in both types of tablets, combined with insufficient sensibility of the technique which does not enable us to put forward elements which abundance is <0.5%. However, the presence of silica seems to be ubiquitous for the CFG condition: the whole of analysed particles contain silica, including the fragments that cause the filtrating membrane to be blocked. The source of this silica could be the colloidal anhydrous silica, such as talc present in the generic. Under used analytical conditions, the origin of particles containing silica is impossible to determine.

However, these results remain surprising, leading to questions concerning the nature of apparent insoluble excipients. Contrary to active substances, there is not a specific pharmaceutical excipient industry: most of the time, it is only a transfer from an alimentary or cosmetic use, for example, to a pharmaceutical use. Patricia Rafidison, who represents the International Pharmaceutical Excipients Council and who was the National Pharmacy Academy’s guest at the time of a thematic session on pharmaceutical raw materials, confessed that it is was difficult to know where the excipients came from, since sometimes the suppliers themselves did not know what pharmaceutical use could be made of their product .

To conclude, we have shown that the injection procedure used by injectable drug users enables the extraction of about 90% of the buprenorphine contained in the sublingual tablets available on the market. The differences in galenic formulations between Subutex and its generics are also present in the solutions that users could self-inject. After using a cotton pad, there are many more insoluble particles, and they present an average size that is inferior in generic buprenorphine solution than in Subutex solution. After cotton filtration, we can also observe an important population of particles which size is inferior to 1 µm in the generic buprenorphine solutions, but not in Subutex solutions (figure 4E and 4J). All of the insoluble particles found in generic buprenorphine solutions after cotton filtration contain silica, whereas no mineral element was to be identified in the insoluble particles of Subutex.

Because of the skin biopsy was originally intended for pathology diagnostic, precise chemical identification of particles contained silica remain impossible. Nevertheless the particles identified in CFG solutions (figure 5D) and the very dense particles contained silica identified in the skin biopsy (figure 1D) might be the same. A precise chemical and structural identification of particles in situ should enable us to confirm this link.

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Addiction, Abuse, and Misuse
  • Respiratory and CNS Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Adrenal Insufficiency
  • Opioid Withdrawal
  • Hepatitis, Hepatic Events
  • Hypersensitivity Reactions
  • Orthostatic Hypotension
  • Elevation of Cerebrospinal Fluid Pressure
  • Elevation of Intracholedochal Pressure

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SUBOXONE sublingual tablet was evaluated in 497 opioid-dependent subjects. The prospective evaluation of SUBOXONE sublingual tablet was supported by clinical trials using SUBUTEX (buprenorphine tablets without naloxone) and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction.

Few differences in adverse event profile were noted between SUBOXONE and SUBUTEX or buprenorphine administered as a sublingual solution.

The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 1).

Table 1: Adverse Events ≥ 5% by Body System and Treatment Group in a 4-week Study

The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.

Table 2: Adverse Events (≥ 5%) by Body System and Treatment Group in a 16-week Study

Post-marketing Experience

The following adverse reactions have been identified during post approval use of buprenorphine/naloxone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequently reported post-marketing adverse event not observed in clinical trials was peripheral edema.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in SUBOXONE sublingual tablet.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids .

Local Reactions

Glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis.

Read the entire FDA prescribing information for Suboxone (Buprenorphine HCl and naloxone HCl)

What is Suboxone used for?

  • Treatment of addiction to opioids such as heroin in adults and adolescents aged 15 years and over.

Buprenorphine substitution therapy for opioid addiction must be used in combination with other medical, social and psychological treatments.

How does Suboxone work?

Suboxone sublingual tablets contain two active ingredients, buprenorphine and naloxone. Buprenorphine is a type of medicine called an opioid. Naloxone is a type of medicine called opioid antagonist.

Opioids are painkillers such as codeine, morphine and diamorphine (heroin) that work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors. However, opioids also act in the brain to cause feelings of euphoria and hallucinations. They can be addictive and people taking them long-term can become dependent on them.

Buprenorphine is an opioid that is used to wean people off their addiction to stronger opioids such as morphine, heroin and methadone. It is prescribed as a substitute for such drugs. By acting on the same opioid receptors as other opioids, buprenorphine prevents the physical withdrawal symptoms that occur when these drugs are stopped. This prevents physical cravings. Over time, the dose of buprenorphine is gradually reduced until it can be stopped completely.

Buprenorphine is only suitable as an opioid substitute in people who are moderately dependent on other opioids. This is because in addition to stimulating opioid receptors, buprenorphine also blocks them. In people who are dependent on high doses of opioids, this can cause withdrawal symptoms when the buprenorphine is started. For this reason, in people highly addicted to opioids, the daily opioid dose should be reduced gradually before therapy with buprenorphine is started.

Suboxone tablets are designed to dissolve underneath the tongue. This allows the buprenorphine to be absorbed into the bloodstream through the rich supply of blood vessels found in this area. The tablets should not be chewed or swallowed, as this would make them less effective.

The naloxone in Suboxone tablets has little effect when the tablets are taken as intended – underneath the tongue. However, if the tablets are misused and are dissolved and injected, the naloxone will oppose the effect of the buprenorphine so that it doesn’t produce a high. This is intended to reduce the chance of the medicine being misused or abused.

How do I take Suboxone?

  • This medicine should only be taken as directed by your doctor. Follow the instructions given by your doctor or pharmacist. These will also be printed on the label your pharmacist has put on the medicine. If you are unclear about anything you should talk to your doctor or pharmacist.
  • Suboxone tablets should be placed under the tongue and allowed to dissolve. The buprenorphine will be absorbed into the bloodstream through the rich supply of blood vessels found in this area. The tablets dissolve in about 5 to 10 minutes. They should not be sucked, chewed or swallowed, as this would make them less effective. The tablets don’t dissolve as well in a dry mouth, so if your mouth is very dry you should have a drink of water before putting the tablet under your tongue.
  • The tablets can be taken either before or after food, but food and drink should not be consumed until the tablet has dissolved fully.
  • For people taking methadone, the methadone dose should be reduced before this medicine is started. Follow the instructions given by your doctor. The first dose of Suboxone should not be taken any sooner than 24 hours after you last used methadone and only when withdrawal symptoms start to appear. However, buprenorphine may still cause symptoms of withdrawal in people dependent upon methadone.
  • For people dependent on short-acting opioids such as heroin, the first dose of Suboxone should not be taken any sooner than six hours after last using the opioid and only when withdrawal symptoms start to appear. If Suboxone is taken earlier than this it can actually cause withdrawal symptoms.

Important information about Suboxone

  • This medicine may cause drowsiness. If affected do not drive or operate machinery. Drowsiness will be made worse by alcohol, tranquilisers, sedatives and sleeping tablets such as benzodiazepines. Taking these in combination with buprenorphine can also cause potentially dangerous problems with breathing and so should be avoided while you are taking this medicine.
  • In March 2015 a new ‘drug driving’ law came into force, which makes it an offence to drive with certain drugs or prescription medicines above specified limits in your body. Buprenorphine is in the same class of medicines as some of the medicines on the list, which means it may be an offence to drive while you are taking this medicine. The new law will allow police to use roadside drug tests to check for the presence of the prohibited drugs in a driver’s saliva. There are very low limits for illegal drugs, but higher limits for prescribed medicines. This means most people taking buprenorphine as prescribed will not be breaking the law, provided they are not driving dangerously. If you test positive for one of the medicines there is a medical defence if you are taking it as prescribed, as long as your driving is not impaired. If you are taking a high dose of buprenorphine it may therefore be sensible to carry your prescription with you if you feel you are safe to drive, in case you are asked to take a test by the police. You should not drive if you think this medicine affects your ability to drive safely, for example if it makes you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision. If you are driving dangerously while taking this medicine you will be breaking the law.
  • Buprenorphine is a controlled drug. If you are planning to travel abroad with it you should check its legal status in the countries you are travelling through and to. There are legal limits on how much of this medicine you can take abroad with you. If you need to take more than this limit you will have to apply to the Home Office for a licence before you travel. Even if you don’t need a licence, if you are taking this medicine abroad it is always a good idea to carry a letter from your doctor that confirms your need for the medicine. You should always carry the medicine in correctly labelled packaging, as dispensed by the pharmacy.
  • Your liver function should be regularly monitored while you are receiving treatment with this medicine.

Suboxone should be used with caution by

  • People over 65 years of age.
  • Adolescents aged 15 to 18 years old.
  • People who are weak or debilitated.
  • People with severely decreased kidney function.
  • People with mild to moderately decreased liver function.
  • People with hepatitis B or C.
  • People with decreased lung function or breathing problems, eg asthma (see also below).
  • People with low blood pressure (hypotension) or low circulating blood volume (hypovolaemia).
  • People with reduced production of natural steroid hormones by the adrenal glands (adrenocortical insufficiency).
  • People with an underactive thyroid gland (hypothyroidism).
  • People with difficulty passing urine, for example men with an enlarged prostate gland.
  • People with disorders of the bile ducts.
  • People with chronic constipation, inflammatory or obstructive bowel disease.
  • People with a history of convulsions (fits), eg epilepsy.
  • People with a head injury or increased pressure in the brain (raised intracranial pressure).

Suboxone should not be used by

  • Children under 15 years of age.
  • People with very slow shallow breathing (respiratory depression).
  • People having an asthma attack.
  • People with severely decreased liver function.
  • People who are intoxicated with alcohol.
  • People with a serious medical condition caused by withdrawal from alcohol (delirium tremens).
  • People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Suboxone tablets contain lactose).

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • Buprenorphine is not licensed for use during pregnancy. However, when it is prescribed as a substitute for illegal opioids such as heroin, it generally carries a lower risk to the mother and baby than if the mother continues to use illegal drugs. However, if the mother is dependent on buprenorphine during the third trimester of pregnancy, the baby may have withdrawal symptoms and breathing problems after birth and will need to be closely monitored. If you get pregnant while taking this medicine it is very important to get advice from your doctor. Withdrawal from buprenorphine (detox) is not generally recommended during the first or third trimesters of pregnancy. Pregnant women who are prescribed buprenorphine must be closely monitored by their doctor.
  • Small amounts of this medicine may pass into breast milk and it is not licensed for use during breastfeeding. It should be used with caution in women who are breastfeeding because it can potentially cause problems in the nursing baby, such as breathing or feeding problems. If used during breastfeeding the nursing infant may need to be monitored. If the baby appears more sleepy than usual, becomes limp or floppy, or has any changes in its breathing, urgent medical advice is needed. It is important to get medical advice from your doctor before you start breastfeeding if you are taking buprenorphine.

Possible side effects of Suboxone

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

  • Difficulty sleeping (insomnia).
  • Headaches.
  • Constipation.
  • Feeling sick.
  • Sweating.
  • Withdrawal symptoms in people addicted to high doses of opioids.

Common (affect between 1 in 10 and 1 in 100 people)

  • Drowsiness.
  • Anxiety.
  • Depression.
  • Nervousness.
  • High blood pressure.
  • Loss of sex drive.
  • Difficulty getting an erection.
  • Sore throat (pharyngitis).
  • Runny nose.
  • Flu-like symptoms.
  • Migraine.
  • Pins and needles.
  • Cough.
  • Disturbances of the gut such as diarrhoea, vomiting, indigestion, wind and pain in the abdomen.
  • Dizziness.
  • Skin reactions such as rash, itching and hives.
  • Pain in the muscles, joints or back.
  • Feeling weak.
  • Weight loss.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

  • Decreased appetite.
  • Abnormal dreams.
  • Infection of the urinary tract.
  • Infection of the vagina such as thrush.
  • Decrease in the number of healthy white blood cells, red blood cells or platelets in the blood (leukopenia and neutropenia, anaemia and thrombocytopenia).
  • Changes in blood sugar levels.
  • Loss of memory.
  • Low blood pressure.
  • Tremor.
  • Convulsions (fits).
  • Agitation.
  • Swollen glands.
  • Discolouration of the tongue.
  • Mouth ulcers.
  • Hair loss.
  • Dry or scaling skin.
  • Acne.
  • Inflammation or infection of the eye.
  • Kidney stones.
  • Blood in the urine.
  • Difficulty and pain when passing urine.
  • Interference with the body’s temperature regulation (heat stroke or hypothermia).
  • Palpitations.
  • Shortness of breath.
  • Chest pain (angina).
  • Heart attack.
  • Faster or slower than normal heartbeat (tachycardia or bradycardia).
  • Problems with ejaculation.

The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it’s necessary they’ll report it for you.

You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard.

How can Suboxone affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

There may be an increased risk of side effects such as drowsiness, sedation, low blood pressure and slow, shallow breathing that can potentially be fatal, if this medicine is used with other medicines that have a sedative effect on the central nervous system. These include the following, which should be avoided while taking this medicine:

  • alcohol
  • antipsychotics, eg haloperidol, chlorpromazine
  • barbiturates, eg phenobarbital, amobarbital
  • benzodiazepines, eg diazepam, temazepam
  • muscle relaxants, eg baclofen
  • other opioids, eg codeine, tramadol, morphine
  • sedating antihistamines, eg chlorphenamine, hydroxyzine
  • sleeping tablets, eg zopiclone
  • tricyclic antidepressants, eg amitriptyline.

In people who are dependent on high doses of other opioids, eg morphine, diamorphine, methadone, this medicine may cause some withdrawal symptoms. This is because buprenorphine can block some of the effects of other opioids. People highly dependent on other opioids should have their daily opioid dose reduced before starting treatment with this medicine.

The following medicines may increase the blood level of buprenorphine and you may need a lower dose if you are taking one of these:

  • azole antifungals such as itraconazole or ketoconazole
  • macrolide antibiotics such as erythromycin or clarithromycin
  • protease inhibitors for HIV infection, such as ritonavir, indinavir, saquinavir.

The following medicines may decrease the blood level of buprenorphine and so could cause withdrawal symptoms if taken by someone dependent on buprenorphine:

  • carbamazepine
  • phenobarbital
  • phenytoin
  • rifampicin
  • the herbal remedy St John’s wort (Hypericum perforatum).

The manufacturer states that this medicine should be used with caution in people who are taking a type of medicine called a monoamine oxidase inhibitor (MAOI), for example, the antidepressants isocarboxazid, phenelzine or tranylcypromine.

Other medicines containing buprenorphine and naloxone

There are currently no other medicines available in the UK that contain this combination of buprenorphine and naloxone together. However, the ingredients are available separately.

The following medicines contain only buprenorphine and are used for the treatment of opioid addition:

  • Gabup
  • Prefibin
  • Subutex.

Buprenorphine sublingual tablets are also available without a brand name, ie as the generic medicine.

The following medicines also contain buprenorphine, but these are used for treating severe pain, not opioid addiction:

  • BuTrans patches.
  • Hapoctasin patches.
  • Temgesic injection.
  • Temgesic sublingual tablets.
  • Tephine sublingual tablets.
  • Transtec patches.

Naloxone injection is available generically (ie without a brand name).

Last updated 26.05.2015

Suboxone (buprenorphine and naloxone)

You may wonder how Suboxone compares to other drugs used to treat opioid dependence. Below are comparisons between Suboxone and several medications.

Suboxone vs. Subutex

Suboxone is a brand-name medication that contains two drugs: buprenorphine and naloxone.

Subutex was a brand-name drug that contained buprenorphine, one of the ingredients in Suboxone. Brand-name Subutex is no longer available. There are no brand-name forms of buprenorphine currently available for treating opioid dependence. (The ones that are available are used to treat pain.)

Uses

Suboxone and buprenorphine, the generic form of Subutex, are both FDA-approved for treating opioid dependence. This includes both the induction and maintenance phases of treatment.

During the induction phase, the drug decreases withdrawal symptoms while you stop or reduce opioid use. During the maintenance phase, the drug keeps withdrawal symptoms and cravings in check as you complete your drug abuse or addiction treatment program.

Forms and administration

Suboxone comes as an oral film that can be used under your tongue (sublingual) or in your cheek (buccal). Buprenorphine forms used for treating opioid dependence include an oral film, a sublingual tablet, and an implant for under the skin.

Effectiveness

In one study, Suboxone and buprenorphine were equally effective for reducing withdrawal symptoms during the induction phase (the first phase) of opioid dependence treatment.

In another study, starting induction treatment on day 1 with Suboxone was just as effective as starting with buprenorphine and then switching to Suboxone on day 3.

The Substance Abuse and Mental Health Services Administration generally recommends Suboxone rather than buprenorphine for both the induction and maintenance phases of opioid dependence treatment.

However, Suboxone is only appropriate for induction in people who are dependent on short-acting opioids such as heroin, codeine, morphine, or oxycodone (Roxicodone, RoxyBond).

Buprenorphine, on the other hand, is recommended for people who are dependent on long-acting opioids such as methadone.

Side effects and risks

Suboxone and buprenorphine are very similar drugs and cause similar common and serious side effects.

More common side effects

Examples of the more common side effects of Suboxone and buprenorphine include:

  • headache
  • opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
  • nausea
  • vomiting
  • stomach pain or upset
  • diarrhea
  • anxiety
  • insomnia (trouble sleeping)
  • sweating
  • depression
  • constipation
  • chills
  • weakness or fatigue
  • dizziness
  • cough
  • fever
  • runny nose
  • sore throat
  • back pain

Serious side effects

Examples of serious side effects shared by Suboxone and buprenorphine include:

  • severe allergic reaction
  • abuse and dependence
  • breathing problems and coma
  • hormone problems (adrenal insufficiency)
  • liver damage
  • severe withdrawal symptoms

Costs

Suboxone is a brand-name drug. It’s also available in a generic version. Generics are often less expensive than brand-name drugs.

The Subutex brand-name product is no longer available. It’s only available in its generic version, buprenorphine. There are no brand-name forms of buprenorphine available that are used to treat opioid dependence.

Buprenorphine and Suboxone cost about the same amount. However, the actual amount you pay will depend on your insurance.

Suboxone vs. methadone

Suboxone is a brand-name medication that contains two drugs: buprenorphine and naloxone. Methadone is a generic medication. It’s also available in a brand-name version called Dolophine.

Uses

Suboxone is FDA-approved to treat opioid dependence, including both the induction and maintenance treatment phases.

During the induction phase, the drug decreases withdrawal symptoms while you stop or reduce opioid use. During the maintenance phase, the drug keeps withdrawal symptoms and cravings in check as you complete your drug abuse treatment program.

Methadone is FDA-approved only for the maintenance phase of opioid dependence treatment. It’s used off-label for the induction phase of treatment. Methadone is also FDA-approved to treat moderate-to-severe pain.

In addition, methadone is approved for treatment during opioid detoxification. Detoxification programs are generally short-term, inpatient treatment plans used to wean people off of drugs such as opioids or alcohol. Opioid dependence treatment, on the other hand, is a longer-term approach to reducing dependence on opioids, with most of the treatment being done on an outpatient basis.

Forms and administration

Suboxone comes as an oral film that can be used under your tongue (sublingual) or between your gums and your cheek (buccal).

Methadone comes in several forms, including:

  • oral tablet
  • oral solution
  • tablet for oral suspension
  • solution for injection

Effectiveness

Suboxone and methadone have been compared in clinical studies evaluating their use for treating opioid dependence.

In a 2013 study, Suboxone and methadone were found to be equally effective for reducing the use of opioids and keeping users in their treatment program.

A 2014 study found that people taking Suboxone used opioids less compared to people taking methadone. However, the people taking methadone were more likely to stay in their treatment program.

An analysis of several studies found that overall, Suboxone was more effective for reducing the use of opioid drugs, but methadone was more effective for keeping users in their treatment program.

Side effects and risks

Suboxone and methadone have some similar side effects, and some that differ. Below are examples of these side effects.

Suboxone and methadone Suboxone Methadone
More common side effects
  • headache
  • nausea
  • vomiting
  • constipation
  • stomach pain or upset
  • anxiety
  • insomnia (trouble sleeping)
  • dizziness
  • weakness or fatigue
  • sweating
  • opioid withdrawal symptoms
  • depression
  • chills
  • cough
  • fever
  • runny nose
  • sore throat
  • diarrhea
  • back pain
  • loss of appetite
  • confusion
  • nervousness
  • disorientation or confusion
  • dry mouth
  • blurred vision
Serious side effects
  • breathing problems*
  • coma
  • abuse and dependence*
  • hormone problems (adrenal insufficiency)
  • severe allergic reaction
  • liver damage
  • severe withdrawal symptoms
  • life-threatening arrhythmia (QT-interval prolongation) *
  • serotonin syndrome
  • severe low blood pressure
  • seizures

*Methadone has a boxed warning from the FDA. This is the strongest warning that the FDA requires. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Costs

Suboxone is a brand-name drug. It’s also available in a generic version. Generics are often less expensive than brand-name drugs.

Methadone is a generic drug. It’s also available as a brand-name version called Dolophine.

Methadone usually costs less than brand-name or generic Suboxone. However, the actual amount you pay will depend on your insurance.

Suboxone vs. Zubsolv

Both Suboxone and Zubsolv are brand-name medications that contain two drugs: buprenorphine and naloxone.

Uses

Both Suboxone and Zubsolv are FDA-approved to treat opioid dependence, including the induction and maintenance phases of treatment.

During the induction phase, the drug decreases withdrawal symptoms while you stop or reduce opioid use. During the maintenance phase, the drug keeps withdrawal symptoms and cravings in check as you complete your drug abuse treatment program.

Forms and administration

Suboxone comes as an oral film that can be used under your tongue (sublingual) or in your cheek (buccal).

Zubsolv comes as an oral tablet that’s used under your tongue.

Effectiveness

Suboxone and Zubsolv contain the same drugs and are used in the same way to treat opioid dependence. They’re expected to be equally effective. The decision to use Suboxone or Zubsolv is based on personal preference for use of the sublingual film or tablet.

Side effects and risks

Suboxone and Zubsolv contain the same drugs and cause similar common and serious side effects.

More common side effects

Examples of the more common side effects of Suboxone and Zubsolv include:

  • headache
  • opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
  • nausea
  • vomiting
  • constipation
  • diarrhea
  • stomach pain or upset
  • anxiety
  • insomnia (trouble sleeping)
  • sweating
  • depression
  • chills
  • weakness or fatigue
  • dizziness
  • cough
  • fever
  • runny nose
  • sore throat
  • back pain

Serious side effects

Examples of serious side effects shared by Suboxone and Zubsolv include:

  • severe allergic reaction
  • abuse and dependence
  • breathing problems and coma
  • hormone problems (adrenal insufficiency)
  • liver damage
  • severe withdrawal symptoms

Costs

Suboxone and Zubsolv are brand-name drugs. There’s a generic version of Suboxone film. There’s no generic version of Zubsolv sublingual tablets.

Zubsolv usually costs less than brand-name or generic Suboxone. However, the actual amount you pay will depend on your insurance.

Suboxone vs. Vivitrol

Suboxone is a brand-name medication that contains two drugs: buprenorphine and naloxone. Buprenorphine is classified as an opioid partial agonist-antagonist. This means it has some effects like opioid drugs, but it also blocks other opioid effects.

Naloxone is classified as an opioid antagonist. This means it blocks the effects of opioid drugs.

Vivitrol is a brand-name medication that contains the drug naltrexone. Naltrexone is an opioid antagonist, similar to the naloxone contained in Suboxone.

Uses

Suboxone is FDA-approved to treat opioid dependence. This includes two phases of treatment: induction and maintenance.

During the induction phase, the drug decreases withdrawal symptoms while you stop or reduce opioid use. During the maintenance phase, the drug keeps withdrawal symptoms and cravings in check as you complete your drug abuse treatment program.

Vivitrol is also approved to treat opioid dependence. However, it’s only approved for preventing relapse in people who have completely stopped abusing opioids.

Forms and administration

Suboxone comes as an oral film that can be used under your tongue (sublingual) or in your cheek (buccal).

Vivitrol comes as an extended-release injection that’s given in a doctor’s office or clinic.

Effectiveness

Suboxone and Vivitrol have been compared in clinical studies. These studies evaluated the drugs’ use for preventing relapse and maintaining abstinence from heroin or opioid use.

A 2017 study found that Vivitrol and Suboxone were equally effective for reducing opioid and heroin use over 12 weeks. A 2018 study found that Suboxone was more effective for preventing relapse and was easier to use than Vivitrol.

Side effects and risks

Suboxone and Vivitrol have some similar side effects, and some that differ. Below are examples of these side effects.

Suboxone and Vivitrol Suboxone Vivitrol
More common side effects
  • nausea
  • vomiting
  • diarrhea
  • stomach pain or upset
  • sore throat
  • insomnia (trouble sleeping)
  • anxiety
  • depression
  • weakness or fatigue
  • back pain
  • dizziness
  • headache
  • opioid withdrawal symptoms
  • sweating
  • constipation
  • chills
  • cough
  • fever
  • runny nose
  • dry mouth
  • injection site tenderness and pain
  • joint pain
  • muscle cramps
  • rash
  • dizziness
  • loss of appetite
  • toothache
Serious side effects
  • severe allergic reaction
  • liver damage
  • abuse and dependence
  • breathing problems and coma
  • hormone problems (adrenal insufficiency)
  • severe withdrawal symptoms
  • severe depression and thoughts of suicide
  • pneumonia

Costs

Suboxone and Vivitrol are brand-name drugs. There’s a generic version of Suboxone, but there’s no generic version of Vivitrol. Generic versions often cost less than brand-name drugs.

Vivitrol usually costs much more than brand-name or generic Suboxone. The actual amount you pay will depend on your insurance.

Suboxone vs. Bunavail

Both Suboxone and Bunavail are brand-name medications that contains two drugs: buprenorphine and naloxone.

Uses

Both Suboxone and Bunavail are FDA-approved to treat opioid dependence. This includes both the induction phase and the maintenance phases of treatment.

During the induction phase, the drug decreases withdrawal symptoms while you stop or reduce opioid use. During the maintenance phase, the drug keeps withdrawal symptoms and cravings in check as you complete your drug abuse treatment program.

Forms and administration

Suboxone is available as an oral film that can be used under your tongue (sublingual) or between your gums and your cheek (buccal).

Bunavail is available as a film that’s placed between your gums and your cheek (buccal).

Effectiveness

Suboxone and Bunavail contain the same drugs and are used in the same way to treat opioid dependence. They’re likely to be equally effective. The decision to use Suboxone or Bunavail is based on personal preferences for use of one product or the other.

Side effects and risks

Suboxone and Bunavail contain the same drugs and cause similar common and serious side effects.

More common side effects

Examples of the more common side effects of Suboxone and Bunavail include:

  • headache
  • opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
  • nausea
  • vomiting
  • constipation
  • stomach pain or upset
  • diarrhea
  • anxiety
  • insomnia (trouble sleeping)
  • sweating
  • depression
  • chills
  • weakness or fatigue
  • dizziness
  • cough
  • fever
  • runny nose
  • sore throat
  • back pain

Serious side effects

Examples of serious side effects shared by Suboxone and Bunavail include:

  • severe allergic reaction
  • abuse and dependence
  • hormone problems (adrenal insufficiency)
  • liver damage
  • severe withdrawal symptoms
  • breathing problems
  • coma

Costs

Suboxone and Bunavail are brand-name drugs. There’s a generic version of Suboxone, but there’s no generic version of Bunavail. Generic versions often cost less than brand-name drugs.

Bunavail usually costs less than brand-name or generic Suboxone. The actual amount you pay will depend on your insurance.

Suboxone vs. Naltrexone

Suboxone is a brand-name medication that contains two drugs: buprenorphine and naloxone. Buprenorphine is classified as an opioid partial agonist-antagonist. Naloxone is classified as an opioid antagonist.

Naltrexone is a generic medication. Naltrexone is classified as an opioid antagonist, similar to the naloxone contained in Suboxone.

Uses

Suboxone is FDA-approved to treat opioid dependence. This includes both the induction phase and the maintenance phases of treatment.

During the induction phase, the drug decreases withdrawal symptoms while you stop or reduce opioid use. During the maintenance phase, the drug keeps withdrawal symptoms and cravings in check as you complete your drug abuse treatment program.

Naltrexone is also approved to treat opioid dependence. However, it’s only approved for preventing relapse in people who have completely stopped abusing opioids.

Forms and administration

Suboxone comes as an oral film that can be used under your tongue (sublingual) or between your gums and your cheek (buccal).

Naltrexone comes as an oral tablet.

Effectiveness

A 2016 clinical study found that Suboxone was more effective for reducing opioid use than naltrexone over 12 weeks.

Side effects and risks

Suboxone and naltrexone have some similar side effects, and some that differ. Below are examples of these side effects.

Suboxone and Naltrexone Suboxone Naltrexone
More common side effects
  • insomnia (trouble sleeping)
  • anxiety
  • stomach pain or upset
  • nausea
  • vomiting
  • constipation
  • weakness or fatigue
  • headache
  • depression
  • dizziness
  • chills
  • opioid withdrawal symptoms
  • sweating
  • cough
  • fever
  • runny nose
  • sore throat
  • diarrhea
  • back pain
  • loss of appetite
  • muscle pain
  • thirst
  • irritability
  • delayed ejaculation (in men)
  • rash
Serious side effects
  • liver damage
  • severe withdrawal symptoms
  • severe allergic reaction
  • abuse and dependence
  • breathing problems and coma
  • hormone problems (adrenal insufficiency)
  • severe depression and thoughts of suicide

Costs

Suboxone is a brand-name drug. It’s also available in a generic version. Generic versions often cost less than brand-name drugs.

Naltrexone oral tablet is a generic drug. It’s not available as a brand-name drug. (However, naltrexone also comes as extended-release injection. This form is only available as the brand-name drug Vivitrol .)

Naltrexone usually costs less than brand-name or generic Suboxone. The actual amount you pay will depend on your insurance.

Jeff, I am no authority just as all the rest of us. However, I do have fairly strong feelings on your post in particular. I absolutely agree with Sub- zero’s post as it indicates stabilizing before anything. It also indicates tapering but also cautions against a fast taper. IÃÂà ƒÂƒÃ‚Â‚ÃƒÂ‚Ã‚Â‚ÃƒÂƒÃ‚ÂƒÃƒÂ‚Ã‚ÂƒÃƒÂƒÃ‚Â‚ÃƒÂ‚Ã‚Â‚ÃƒÂ ƒÃ‚ƒÃ‚‚’ll add to that my constant being miffed at your doctorÃà‚‚Ã ‚’s advice and that of doctors in general who Rx Sub.
# 1, why do they insist on induction with suboxone instead of Subutex? A lot of side effects could be ruled out during induction simply removing the nalexone factor. Spit, S==t. # 2, how in this world, of readily available info, can doctors consistently start someone at 12 mg and above of Sub to overcome the WDs and cravings of under 100mg /day opiate use? # 3, how can yourÃà‚‚Â ’s and doctors in general constantly be surprised at side effects from Sub and forever call something like 12 mgs of Sub such a small amount? Freaking amazing.
I am all for Sub and feel it has done everything I could hope for getting me out of my ocycodone use nightmare. That said, I also feel there is a lot of confusing stuff one is going to run into going through the process of receiving the benefit of this drug. In your case, I feel you are starting on a way too high dose. Somehow you need to get stable on something a lot less, but you need to get there in small increments. After you stabilize, you probably need to continue decreasing your dose, again, bear in mind to take it slowly and not be in a hurry. Just for chronic back pain relief sake, or example, over my 9 months of Sub use I have reduced from 3 to 4 X day doses of 8 mgs down to 3 to 4 mg day doses of .5 and .25 (half and quarter a mg) and still maintained the pain relief. This from a 240 to 320 mg / day oxy use. This is, in a lot of ways, a powerful drug and 12 mg/day is simply not a small amount.
Concerning fatigue/ sleepiness, I am also somewhat confused. During my whole process of slowly tapering, I experienced, defiantly yet thankfully mildly, both the ultra sleepiness and also the fatigue type general funk. I truly think they are two different things involved with Sub use. My jury is still out as to what and how to deal with it, but I believe the extreme sleepiness out of nowhere is due to too much Sub. I also believe the general fatigue or general malaise, or funk feeling of something not quite right, is due to too little Sub or reducing too fast. Sort of the PAWS feelings we hear of people experiencing when they discontinue their DOC or Sub as their addiction or brain tries to heal. Hopefully, you will not deal with this latter effect due to your small amount of time and mgs of opiate use. Whatever the case, Mike rightly points out the need not to rush things especially due to posts. There are some on some boards that have usured more people quickly off Sub and into relapse than any drug dealer could ever hope for
Jeff, mine is only one of the opinions that you are going to look at. ThatÃà‚‚ ’s the best thing you are doing for yourself, that is, looking and reading a multiple of opinions. I could only wish your doctor would do the same. IÃÂà ƒÂƒÃ‚Â‚ÃƒÂ‚Ã‚Â‚ÃƒÂƒÃ‚ÂƒÃƒÂ‚Ã‚ÂƒÃƒÂƒÃ‚Â‚ÃƒÂ‚Ã‚Â‚ÃƒÂ ƒÃ‚ƒÃ‚‚’ve got to go back to what IÃÂà ƒÂƒÃ‚Â‚ÃƒÂ‚Ã‚Â‚ÃƒÂƒÃ‚ÂƒÃƒÂ‚Ã‚ÂƒÃƒÂƒÃ‚Â‚ÃƒÂ‚Ã‚Â‚ÃƒÂ ƒÃ‚ƒÃ‚‚’m supposed to being doing today, but I must add the following.
Knowing how helpful it was later on, no matter what I chose to do regarding the potential life saving use of Sub to get out of whatever trap I found myself in, I would insist your ill informed doctor Rx 2 mg Subutex instead of 8 mg suboxone or even 2 mg Suboxone. Granted, the 2 mg Tex is more expensive, however they are well worth it for the benefits and the relative ease they can be divided into the necessary ultra small increments of a gradual and hopefully smooth taper. ThatÃà‚‚Â ’s all I want to rant about now, and as well as all of us, I do wish you the best, Wil

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I recently receive e-mails or read posts at Suboxone Forum that go something like this:
I used all kinds of pain pills over the past ten years—Vicodin, then oxycodone, methadone, and even fentanyl patches. Then I got into heroin for a year and finally hit my rock bottom. I went to a Suboxone doctor and he put me on 16 mg per day. At first everything was great, but I don’t like the side effects. I get so tired every day. I’m not happy like I used to be. I wake up in the morning and don’t have any energy or excitement for life. I really don’t like what the Suboxone is doing to me and want to stop.
Sometimes it is a little different—the first part is the same, but then the person writes:
I really wanted to stop taking it so that my body is free of chemicals so I stopped. I was real sick for a month and now I don’t feel like myself—I am tired, I feel depressed and angry, and I’m wondering what the Suboxone did to my opiates—am I ruined forever?
I am a psychiatrist, and only about a third of my practice consists of addiction work. I get e-mails at times after people read the blog for my psychiatric practice at www.patienttimes.fdlpsychiatry.com. A typical message will be similar to this:
Dear Dr. Junig (they tend to be more polite to me there),
I used to be a very happy, energetic person. In high school I was outgoing and everybody liked me, and I had tons of friends. The problem? Now I am in my 30’s and I’m never happy anymore. I have worked at the same place for ten years (or maybe, I change jobs every 18 months) and every day I wake up and dread getting out of bed and going to work. I keep telling myself I should exercise, but I never get started actually doing it. I’m single and don’t have any interest in dating (or maybe, I’ve been married to the same person for ten years and sometimes I can’t stand the look of him). I’ve read about vitamin D deficiency and wonder if that is my problem—all I know is that I am getting more and more depressed and tired. My sleep is crappy too. What should I do?
I have an answer to the first two messages, and the third message is a hint. Does anyone know how I would reply to the first two messages? What would I say? If you get my point and describe it correctly in the comments section—either describe the -general point, or write the reply that I would write– by 6 PM Central time tomorrow, Sunday, September 27, I will send you a free copy of my e-book ‘user’s guide to Suboxone’. EVERY person who gets it correct will get a copy. The ONE person who explains my point the best will receive the user’s guide plus a copy of each of these three recordings—stopping Suboxone, how long will you take that stuff, and opiate dependence treatment options. That’s like almost a thousand—or a hundred dollars—something like that. You don’t have to put your real name or e-mail address, but your comment MUST be entered in the comment section after this post. I might have to approve it if you haven’t written a comment before, but that’s OK—it will still count, as long as it is written and submitted by 6 PM. C’mon folks—take a shot!
JJ

The Dangers of Long Term Suboxone Use

What is Suboxone?

Suboxone, once thought to be a miracle drug to treat opiate addiction, is actually causing an epidemic in it’s own right. Suboxone is a mixture of buprenorphine (a semi-synthetic opioid) and naloxone (an opiate blocker) and has seemingly become overprescribed by medical professionals to an uninformed patient population.

Available in the United States since 2003, studies demonstrate that the drug was originally approved by the FDA to be used as a medicine to aid opiate addicted patients that were going through the painful effects of opiate withdrawal. The use of the drug was meant to treat opiate addiction patients in the privacy of a doctor’s office to help opiate-addicted patients overcome addiction* . However, it seems clear many professionals started to see the financial benefits of prescribing Suboxone as a maintenance drug (similar to how methadone has been prescribed for years.) Because of this, many patients have been on a Suboxone maintenance program for many years, some as long 10 plus years.

Suboxone as an Opiate Maintenance Drug..

These patients were attempting to overcome addictions to powerful narcotics like heroin and OxyContin and many doctors offered Suboxone as the answer to these patients. However, regardless of the justifications or rationalizations from many within the medical and addiction treatment field, the basic premise of a Suboxone maintenance program is trading one illegal drug for a legal drug. It is saying “take this pill and you’ll be okay” or “take this pill and it will take care of your addiction.” Basically, patients going into a doctor’s office to find away to “overcome their addiction” are years later finding themselves still physically dependent and addicted to a substance. Suboxone keeps opiate withdrawal symptoms at bay, but does not offer any actual treatment and clearly does not offer a solution for overcoming addiction. Take the Suboxone supply away from a person on a Suboxone maintenance program and there is little doubt that they will turn to heroin or OxyContin or another form of opiate once withdrawal symptoms begin. This is not the patients fault- they were sold a faulty bill of goods by many of those people prescribing Suboxone.

Sure, a competent and informed doctor will explain that a patient needs treatment for their psychological and emotional issues as well, and a competent doctor will be informed of the physical effects of long term Suboxone use, but the question is how many doctor’s are uninformed and therefore unable to give this necessary information to their patients? Patients being prescribed Suboxone were told this prescribed medicine would be the solution to their problem of drug addiction. In addition to the fact that a patient is still physically dependent on a substance to function, there are several disturbing effects of Suboxone that are rarely discussed.

Is Suboxone Bad? What can be done to lessen the side effects?

Because Suboxone is often prescribed by individual doctors that are untrained in addiction medicine and treating addiction (look up the requirements that a doctor needs to be allowed to prescribe Suboxone), there are a lot of issues with the drug that go unnoticed and unregulated. Suboxone as a medication for opiate detox is an excellent drug. In the hands of an informed, trained physician, Suboxone can make a painful opiate detox much more comfortable. Suboxone is an excellent drug for aiding an opiate addict through withdrawal symptoms. It works wonderful in that manner. However, long term Suboxone use causes a myriad of medical issues. Furthermore, many long term Suboxone users claim getting off Suboxone is more difficult than even getting off OxyContin or heroin. Why? Because unlike an intensely painful 5-7 or even 14 day detox from opiates, Suboxone can even stay in the body for up to 8 or 9 days, the detox from Suboxone can last weeks or even months and with it brings not only painful physical issues but also highly concerning psychological issues. Patients complain of horrific bouts of depression. Many claim that the withdrawal symptoms of Suboxone, unlike the intense withdrawal of heroin or OxyContin, comes in waves and can lasts for weeks or months.

Long term Suboxone use can cause withdrawal symptoms such as: anxiety, depression, night sweats, fatigue, nausea, restlessness, joint and muscle pain, insomnia, loss of libido, lack of motivation and in some cases psychosis. Unlike opiate withdrawal symptoms that last maybe up to a week, these Suboxone withdrawal symptoms can last for several weeks to several months. How does this sound any better than being physically dependent on heroin or prescription painkillers?

The Truth about Opiate Addictions

The truth is that opiate addicts are often times looked at as being “unable to recover” by many within the medical field. The relapse rate for opiate addicts is extremely high and the rate of overdose and death is much higher than any other drug in the addiction treatment field. Often opiate addicts that go to treatment and achieve some time away from their drug of choice end up using opiates again when they relapse and because of a decreased tolerance end up using too much and overdosing. Many of them die. Because of this, opiate replacement therapy like Suboxone and methadone maintenance is often used by doctors and some treatment centers as a model known as “harm reduction”.

This means that these entities don’t necessarily look at an opiate patient as someone that can ever achieve real abstinence or sobriety, but rather as a number that they are trying no to add as an overdose statistic. Like, “this kid can never get clean so at least let’s try to keep them from killing themselves from an overdose.” This seems like an excellent theory, but there are two main problems:

  1. This idea is selling the patient short. Treating them with a “harm reduction” model rather than actually offering them comprehensive addiction treatment seems to be lazy, uninformed and shows little understanding of addiction treatment. Either that, or the doctor is simply looking for a paycheck since it is much more profitable to keep someone on long term maintenance than actually getting them clean and sober by giving them comprehensive treatment.
  2. The wonder drug Suboxone that is the catalyst for this new “opiate replacement therapy” maintenance model is beginning to cause more harm than good. More and more people are getting prescribed Suboxone, getting less actual treatment and not actually improving the quality of their lives. They are simply not using opiates…sometimes. Often they replace opiate use with increased problem drinking or the use of other illicit drugs like cocaine or benzodiazepines like Xanax. Many still suffer from underlying emotional or traumatic issues that are never addressed. And when these people finally realize that their “solution” of Suboxone has become a problem and actually want to get off the crutch, they find it harder to do than the opiate they were originally trying to get off of in the first place.

Now, there are many competent, informed doctors that utilize Suboxone well, couple it comprehensive treatment and take a holistic look at each patient and their situation. There are certain cases where perhaps Suboxone maintenance or a long term Suboxone detox model is the best solution for an individuals situation. But that is few and far between. More often than not, many doctors prescribing Suboxone are doing so without requiring the patient to get any type of comprehensive treatment. Additionally, many doctors that prescribe Suboxone require little more than an appointment and a cash payment for a patient to receive the medication. Many doctors, after an initial visit, will simply prescribe the medication after a short follow up visit. This certainly does not seem like comprehensive addiction treatment in the eyes of many professionals. This is certainly not a recovery-based model by any stretch of the imagination.

Struggling with an Opiate Addiction? Contact a Recovery Professional Today!

At Maryland Addiction Recovery Center, we do not believe in a “harm reduction model” of treatment. We do not believe in a long-term “maintenance” model of treatment. We DO believe that Suboxone is a useful medication to aid someone in getting off opiates altogether and we DO use it at MARC utilizing a detox protocol. Some of us are former opiate and heroin addicts now in long-term recovery. Some of us have dealt firsthand with a Suboxone maintenance model and have dealt with the issues of getting off Suboxone. We believe that there is a better way, that actual recovery exists, that you can be free and clear and not need to be medication dependent in this way. We believe that no opiate addict is a lost cause and we don’t believe in selling an addict or their family short by offering an easier, softer way. We believe in actual treatment, comprehensive addiction treatment that supports long-term, sustainable recovery. We believe that any addict can recover.

If you or someone you know is in need of detox, treatment, aftercare or sober living due to drugs and alcohol, please call Maryland Addiction Recovery Center at (410) 773-0500 or email [email protected] For more information on all of our services, please visit www.marylandaddictionrecovery.com

*This original blog post claimed that Suboxone was originally approved as a detox medication. Upon further research, it seems that claim was inaccurate. The original FDA approval was for the treatment of opiate dependence with the benefit that it could be prescribed by a physician in the privacy of a doctor’s office.

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Can You Get High Off Suboxone?

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What Is Suboxone?

Suboxone is a medication prescribed for the treatment of opioid addiction. Some of the more commonly abused opioid narcotics are heroin, OxyContin, hydrocodone, and Vicodin. Suboxone is a combination of buprenorphine and naloxone; together, the two drugs may be used to help addicts overcome their dependence on opioids.

  • Buprenorphine is a powerful and potentially addictive opioid painkiller. It belongs in a class of drugs known as partial opioid agonists, meaning that it partially activates the same receptors in the brain as more potent opioids. Buprenorphine produces a sense of euphoria, but it does not provide an intense “high” sensation.
  • Naloxone is an opioid antagonist, meaning that it completely blocks the opioid receptors in the brain and prevents the user from feeling any of the narcotic effects of opioid drugs. It was added to discourage addicts from abusing Suboxone itself and to minimize the risk of overdose.

In conjunction with therapy, Suboxone has been found to be very effective at reducing opioid abuse as long as it is used carefully under a physician’s supervision.1 It is available as a sublingual tablet or a sublingual film. It should not be crushed, chewed, or swallowed whole but allowed to dissolved slowly in the mouth.2

How Suboxone is Abused

Suboxone cannot make you high. Nonetheless, it is commonly misused. As much as 50% of the Suboxone prescribed in the United States is diverted to non-medical uses; often, it is sold illegally on the street along with heroin and other powerful narcotics. Suboxone was approved for the treatment of opioid addiction in 2002. Addicts soon discovered that it could also be used to maintain their addiction. This is because Suboxone alleviates the symptoms of withdrawal that addicts experience between highs. If the unpleasant effects of withdrawal can be successfully managed by using Suboxone, the addict is free to abuse his drug of choice. Also, if the addict cannot get the drug they really want to abuse, Suboxone will keep them in a mellow state until it becomes available.

Since buprenorphine is itself an opioid drugs, some individuals will attempt to get high by tampering with Suboxone and using it improperly. Suboxone tablets can be crushed and the resulting powder taken by nasal insufflation (“snorting”) or dissolved in solution and injected into the bloodstream. However, injection often produces an immediate withdrawal because naloxone cancels out the activity of opioid drugs present in the user’s system, including buprenorphine.

The euphoric effects of Suboxone are mild compared to other opioids; however, users often combine it with other substances to heighten its effects.

The euphoric effects of Suboxone are mild compared to other opioids; however, users often combine it with other substances to heighten its effects. Many combinations can be lethal because both Suboxone and the substances taken with it depress the respiratory system. Some common substances that are abused with Suboxone include the following:

  • Alcohol: Adds to breathing difficulties; potentially fatal.2
  • Sedatives/tranquilizers (benzodiazepines): May slow breathing to dangerous, potentially fatal levels.3
  • Heroin: Naloxone blocks the receptors for heroin stimulation, so the body goes into rapid withdrawal.
  • Stimulants: Effects counter the relaxation provided by the buprenorphine and may lead to stimulant overdose.

Suboxone Doesn’t Make You High

Since everyone reacts differently to drugs, it’s possible that you won’t experience any sort of euphoric effect from abusing Suboxone regardless of the method you use. If you still experience cravings or if you feel “high” while taking Suboxone as prescribed, it’s a sign that it isn’t working properly for you. Be honest with your physician and admit that Suboxone isn’t working.

What Are the Symptoms of a Suboxone Overdose?

If you experience any of the following symptoms of a Suboxone overdose, get medical help immediately:2

  • Lethargy.
  • Confusion.
  • Slow, labored breathing.
  • Feeling faint.
  • Pinpoint pupils.
  • Blurred vision.

How Did I Start Abusing Suboxone?

You can become addicted to Suboxone by taking it for an extended period of time. The longer that you use it, the more likely it is that your body will develop a physical dependence to the drug. Many people struggling with addiction feel that Suboxone withdrawal is just as severe as withdrawal from other opioids like heroin.

Suboxone is intended to be used only for the treatment of opioid addiction. It should be taken on a short-term basis under your doctor’s supervision until you are free of all drugs. If you are using Suboxone for any other purpose, you may have become dependent. Treatment can help.

What Are the Dangers of Abusing Suboxone?

As mentioned previously, injecting dissolved Suboxone may produce instant opioid withdrawal syndrome due to the presence of naloxone. Although snorting or injecting Suboxone provides the user with a mild buzz, the unpleasant naloxone effects often counter that high. In short, the dangers of Suboxone can be summarized as follows:

  • Suddenly discontinuing Suboxone can lead to uncomfortable withdrawal symptoms.
  • Suboxone can have deadly interactions with other drugs like alcohol and sedatives.
  • Suboxone can have uncomfortable side effects, such as respiratory problems, allergic reactions, and problems with coordination.

Seek Help for Your Addiction

Some users find success with Suboxone and others do not. Using Suboxone alone is not enough to treat opioid addiction; you need psychological therapy to address the causes behind your addiction.

Sources

About the Editor

Kindra Sclar, M.A.

Kindra Sclar is a Senior Web Content Editor for American Addiction Centers. Before joining the company, she worked for more than 8 years as a print and web editor for several print and online publishers. Kindra has worked on content…

The following serious adverse reactions are described elsewhere in the labeling:

  • Addiction, Abuse, and Misuse
  • Respiratory and CNS Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Adrenal Insufficiency
  • Opioid Withdrawal
  • Hepatitis, Hepatic Events
  • Hypersensitivity Reactions
  • Orthostatic Hypotension
  • Elevation of Cerebrospinal Fluid Pressure
  • Elevation of Intracholedochal Pressure

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SUBUTEX was supported by clinical trials using SUBUTEX, SUBOXONE (buprenorphine/naloxone sublingual tablet) and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction.

Few differences in adverse event profile were noted between SUBUTEX or buprenorphine administered as a sublingual solution.

The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 1).

Table 1. Adverse Events ≥ 5% by Body System and Treatment Group in a 4-week study

The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.

Table 2. Adverse Events (≥ 5%) by Body System and Treatment Group in a 16-week Study

Postmarketing Experience

The following adverse reactions have been identified during post approval use of buprenorphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequently reported post-marketing adverse events with SUBUTEX not observed in clinical trials, excluding drug exposure during pregnancy, was drug misuse or abuse.

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis has been reported with ingredients contained in SUBUTEX.

Cases of androgen deficiency have occurred with chronic use of opioids .

Glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis.

Read the entire FDA prescribing information for Subutex (Buprenorphine)

Subutex Side Effects

Of course, there’s really no medication that’s without some side effects, and it’s important to have an understanding of Subutex side effects before using it.

First, when someone takes Subutex, they won’t feel a euphoric high, but they may experience some feelings of well-being which are pleasant. When Subutex is taken as directed, it has a relatively low potential for abuse, and it can not only suppress opioid withdrawal symptoms but also decrease cravings for opioids. It also blocks the effects of other opioids.

Some of the common short-term Subutex side effects can include constipation, back pain, hoarseness of the voice, headache, nausea, painful urination, sleep problems or vomiting. Some of the less common but still possible Subutex side effects include diarrhea, feeling lightheaded or dizzy, flushing of the skin or sweating.

Some of the psychiatric Subutex side effects that may occur include insomnia, anxiety, and depression.

In rare cases, severe Subutex side effects can include problems breathing, blurry vision, confusion, shallow breathing, or unusual feelings of tiredness or weakness.

An overdose of Subutex is theoretically possible as well, although not incredibly common. It would usually occur if this drug were combined with something else that depresses the central nervous system, such as alcohol or large amounts of benzodiazepines.

How is it used?

Suboxone Sublingual Film® is a lime-flavoured, rectangular, orange film, which is placed under the tongue to dissolve. The film will not work properly if it is chewed or swallowed.2

Subutex Sublingual Tablets® are also placed under the tongue to dissolve and will not work properly if chewed or swallowed.3

How effective is it?

Buprenorphine treatment is more likely to be successful if it is part of a comprehensive treatment program, which addresses the body, mind and environment in which opioids have been used.

For example, treatment may include a combination of buprenorphine, counselling, alternative therapies and the development of a positive support network of peers, friends and a support group. 1

Buprenorphine maintenance

Buprenorphine maintenance may not work for everyone, so it is important to work with a doctor or drug counsellor to find the best approach.

Advantages of buprenorphine maintenance over heroin use

  • Using buprenorphine on its own is unlikely to result in an overdose.
  • Buprenorphine maintenance keeps the person stable while they make positive changes in their lives.
  • Health problems are reduced or avoided, especially those related to injecting, such as HIV, hepatitis B and hepatitis C viruses, skin infections and vein problems.
  • Doses are required only once a day, sometimes even less often, because buprenorphine’s effects are long lasting
  • Buprenorphine is much cheaper than heroin.4

Effects of buprenorphine

There is no safe level of drug use. Use of any drug always carries some risk. Even medications can produce unwanted side effects. It’s important to be careful when taking any type of drug.

Buprenorphine affects everyone differently, based on:

  • size, weight and health
  • whether the person is used to taking it
  • whether other drugs are taken around the same time
  • the amount taken.

Side effects

The most common side effects of buprenorphine are:

  • constipation
  • headache
  • increased sweating
  • tiredness or drowsiness (especially after a dose)
  • loss of appetite, nausea and vomiting
  • abdominal pain
  • skin rashes, itching or hives
  • tooth decay
  • changes to periods (menstruation)
  • lowered sex drive (males and females)
  • weight gain (particularly for females).1

Withdrawal

Withdrawal from long-term use of buprenorphine may produce some symptoms similar to those experienced through heroin withdrawal.2, 3 It is recommended that withdrawal from buprenorphine is achieved gradually under medical supervision to prevent discomfort and unpleasant effects for the person.1 Withdrawal symptoms vary from person to person, but may include:

  • cold or flu-like symptoms
  • headache
  • sweating
  • aches and pains
  • difficulty sleeping
  • nausea
  • mood swings
  • loss of appetite.1

These effects usually peak in the first 2 to 5 days. Some mild effects may last a number of weeks.

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