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By the way, doctor: Should I take Lunesta to help me sleep?

Published: February, 2006

Q. I have chronic problems sleeping. I hear that Lunesta, a sleeping pill, can be taken long-term. Is that true? Do you recommend it?

A. Lunesta (eszopiclone) is the newest member of a class of prescription sleeping pills called nonbenzodiazepines, which includes zolpidem (Ambien) and zaleplon (Sonata)—also known as Z drugs. These drugs have risen rapidly in popularity, overtaking benzodiazepine medications such as lorazepam (Ativan) and temazepam (Restoril). One of the problems with the older benzodiazepine drugs is that people develop tolerance if they’re taken for longer than 10 days. If you take them regularly, you may need to keep raising the dose to get the same effect.

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New Dosing for Lunesta Cuts Next-day “Hangover” Effect

Recommended starting dose of the sleep aid Lunesta (eszopiclone) is now 1 mg, and reflects new findings that higher doses cause “hangover” effect—impaired large motor skills and memory. Unlike similar action taken to reduce medication side effects of Ambien, the dosage reduction is recommended in both men and women with insomnia.

By Michelle L. Bryson, PharmD, BCPS and

Following reports of a “hangover” effect—memory loss, lack of coordination, and impaired driving skills—after taking Lunesta (eszopiclone), the Food and Drug Administration (FDA) requested the manufacturer of the sleep aid to change the drug label and lower the current recommended starting dose.

According to the FDA, “data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake.”

Taken at bedtime, the recommended starting dose of Lunesta “has been decreased from 2 mg to 1 mg for both men and women” to reduce medication side effects. “The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness. Using lower doses means less drug will remain in the body in the morning hours,” noted the agency in a safety alert sent to doctors.

“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” said Ellis Unger, MD, director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs.”

Why the Dosage Change

The FDA took action following the results of a post-marketing study. The study showed that when people took 3 mg of Lunesta, the next-morning they had “severe psychomotor and memory impairment in both men and women 7.5 hours after taking the drug.” The researchers who conducted the study said that doses can cause impairment to driving skills, memory, and coordination as long as 11 hours after the drug is taken. Despite these long-lasting effects, patients were often unaware they were impaired.

This dosage reduction comes after similar action by the FDA in January 2013, when it requested dose reduction for products containing the popular sleep aid zolpidem (Ambien and Ambien CR). In that case, however, next-day impairment was found only in women taking the recommended dose. The FDA recommended that manufacturers lower the dose of Ambien by half in women.

Pain and Sleep

Many patients with acute and chronic pain have trouble failing asleep and, once asleep, staying asleep. The more pain, the more sleep disturbances, and vice versa. Therefore, many doctors treating patients with chronic pain will evaluate the patient for signs and symptoms of insomnia: patient’s daytime function, overall health, and sleep quality. The next step is to eliminate any habits (like caffeine intake, watching TV in bed, frequent napping) or medications (certain medication can cause insomnia) that may be causing sleep problems.

The main goals of treating insomnia include improving sleep time and quality and reducing daytime impairment. If your doctor recommends a sleep aid or medication, be aware that daytime drowsiness is listed as a common side effect for all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. “The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the-counter drugs, and will update the public as new information becomes available,” noted the press release.

What Patients Should Do

Patients currently taking the 2 mg and 3 mg doses of Lunesta should contact their health care professional to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.

Updated on: 05/24/17

Lunesta

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

CNS Depressant Effects And Next-Day Impairment

LUNESTA is a central nervous system (CNS) depressant and can impair daytime function in some patients at the higher doses (2 mg or 3 mg), even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of symptoms (or even with subjective improvement), and impairment may not be reliably detected by ordinary clinical exam (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of LUNESTA may develop, patients using 3 mg LUNESTA should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.

Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of LUNESTA and concomitant CNS depressants should be considered .

The use of LUNESTA with other sedative-hypnotics at bedtime or the middle of the night is not recommended.

The risk of next-day psychomotor impairment is increased if LUNESTA is taken with less than a full night of sleep remaining (7- to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants; or co-administered with other drugs that increase the blood levels of eszopiclone .

Need To Evaluate For Co-Morbid Diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including LUNESTA. Because some of the important adverse effects of LUNESTA appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly .

Severe Anaphylactic And Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including LUNESTA. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with LUNESTA should not be rechallenged with the drug.

Abnormal Thinking And Behavioral Changes

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative/hypnotics.

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with LUNESTA alone at therapeutic doses, the use of alcohol and other CNS depressants with LUNESTA appears to increase the risk of such behaviors, as does the use of LUNESTA at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of LUNESTA should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above are drug-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Withdrawal Effects

Following rapid dose decrease or abrupt discontinuation of the use of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs .

Timing Of Drug Administration

LUNESTA should be taken immediately before bedtime. Taking a sedative/hypnotic while still up and about may result in short-term memory impairment, hallucinations, impaired coordination, dizziness, and lightheadedness.

Special Populations

Use In Elderly And/Or Debilitated Patients

Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. The dose should not exceed 2 mg in elderly or debilitated patients .

Use In Patients With Concomitant Illness

Clinical experience with eszopiclone in patients with concomitant illness is limited. Eszopiclone should be used with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

A study in healthy volunteers did not reveal respiratory-depressant effects at doses 2.5-fold higher (7 mg) than the recommended dose of eszopiclone. Caution is advised, however, if LUNESTA is prescribed to patients with compromised respiratory function.

The dose of LUNESTA should not exceed 2 mg in patients with severe hepatic impairment, because systemic exposure is doubled in such subjects. No dose adjustment appears necessary for subjects with mild or moderate hepatic impairment. No dose adjustment appears necessary in subjects with any degree of renal impairment, since less than 10% of eszopiclone is excreted unchanged in the urine.

The dose of LUNESTA should be reduced in patients who are administered potent inhibitors of CYP3A4, such as ketoconazole, while taking LUNESTA. Downward dose adjustment is also recommended when LUNESTA is administered with agents having known CNS-depressant effects.

Use In Patients With Depression

Sedative/hypnotic drugs should be administered with caution to patients exhibiting signs and symptoms of depression. Suicidal tendencies may be present in such patients, and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.

Patient Counseling Information

See FDA-approved patient labeling (Medication Guide).

Inform patients and their families about the benefits and risks of treatment with LUNESTA. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with LUNESTA and with each prescription refill. Review the LUNESTA Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that LUNESTA should be taken only as prescribed.

Tell patients that LUNESTA can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients taking the 3 mg dose against driving and other activities requiring complete mental alertness the day after use. Inform patients that impairment can be present despite feeling fully awake.

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with eszopiclone. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur.

Sleep-Driving And Other Complex Behaviors

Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including “sleep driving” and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms.

Suicide

Tell patients to immediately report any suicidal thoughts.

Alcohol And Other Drugs

Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use LUNESTA if they drank alcohol that evening or before bed.

Tolerance, Abuse, And Dependence

Tell patients not to increase the dose of LUNESTA on their own, and to inform you if they believe the drug “does not work”.

Administration Instructions

Patients should be counseled to take LUNESTA right before they get into bed and only when they are able to stay in bed a full night (7–8 hours) before being active again. LUNESTA tablets should not be taken with or immediately after a meal. Advise patients NOT to take LUNESTA if they drank alcohol that evening.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

In a carcinogenicity study in rats, oral administration of eszopiclone for 97 (males) or 104 (females) weeks resulted in no increases in tumors; plasma levels (AUC) of eszopiclone at the highest dose tested (16 mg/kg/day) are approximately 80 (females) and 20 (males) times those in humans at the maximum recommended human dose (MRHD) of 3 mg/day. However, in a 2- year carcinogenicity study in rats, oral administration of racemic zopiclone (1, 10, or 100 mg/kg/day) resulted in increases in mammary gland adenocarcinomas (females) and thyroid gland follicular cell adenomas and carcinomas (males) at the highest dose tested. Plasma levels of eszopiclone at this dose are approximately 150 (females) and 70 (males) times those in humans at the MRHD of eszopiclone. The mechanism for the increase in mammary adenocarcinomas is unknown. The increase in thyroid tumors is thought to be due to increased levels of TSH secondary to increased metabolism of circulating thyroid hormones, a mechanism not considered relevant to humans.

In a 2-year carcinogenicity study in mice, oral administration of racemic zopiclone (1, 10, or 100 mg/kg/day) produced increases in pulmonary carcinomas and carcinomas plus adenomas (females) and skin fibromas and sarcomas (males) at the highest dose tested. The skin tumors were due to skin lesions induced by aggressive behavior, a mechanism not relevant to humans. A carcinogenicity study of eszopiclone was conducted in mice at oral doses up to 100 mg/kg/day. Although this study did not reach a maximum tolerated dose, and was thus inadequate for overall assessment of carcinogenic potential, no increases in either pulmonary or skin tumors were seen at doses producing plasma levels of eszopiclone approximately 90 times those in humans at the MRHD of eszopiclone (and 12 times the exposure in the racemate study). Eszopiclone did not increase tumors in a p53 transgenic mouse bioassay at oral doses up to 300 mg/kg/day.

Mutagenesis

Eszopiclone was clastogenic in in vitro (mouse lymphoma and chromosomal aberration) assays in mammalian cells. Eszopiclone was negative in the in vitro bacterial gene mutation (Ames) assay and in an in vivo micronucleus assay.

(S)-N-desmethyl zopiclone, a metabolite of eszopiclone, was positive in in vitro chromosomal aberration assays in mammalian cells. (S)-N-desmethyl zopiclone was negative in the in vitro bacterial gene mutation (Ames) assay and in an in vivo chromosomal aberration and micronucleus assay.

Impairment Of Fertility

Oral administration of eszopiclone to rats prior to and during mating, and continuing in females to day 7 of gestation (doses up to 45 mg/kg/day to males and females or up to 180 mg/kg/day to females only) resulted in decreased fertility, with no pregnancy at the highest dose tested when both males and females were treated. In females, there was an increase in abnormal estrus cycles at the highest dose tested. In males, decreases in sperm number and motility and increases in morphologically abnormal sperm were observed at the mid and high doses. The no-effect dose for adverse effects on fertility (5 mg/kg/day) is 16 times the MRHD on a mg/m² basis.

Use In Specific Populations

Pregnancy

Risk Summary

Available pharmacovigilance data with LUNESTA use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. Administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose was approximately 200 times the maximum recommended human dose (MRHD) of 3 mg/day based on mg/m² body surface area (See Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) throughout organogenesis showed no evidence of teratogenicity up to the highest doses tested. In rats, reduced fetal weight and increased incidences of skeletal variations and/or delayed ossification were observed at the mid and high doses. The no-observed-effect dose for adverse effects on embryofetal development is 200 times the MRHD of 3 mg/day on a mg/m² basis. No effects on embryofetal development were observed in rabbits; the highest dose tested is approximately 100 times the MRHD on a mg/m² basis.

Oral administration of eszopiclone (60, 120, or 180 mg/kg/day) to pregnant rats throughout the pregnancy and lactation resulted in increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response at all doses. The lowest dose tested is approximately 200 times the MRHD on a mg/m² basis. Eszopiclone had no effects on other developmental measures or reproductive function in the offspring.

Lactation

There are no data on the prescence of eszopiclone in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LUNESTA and any potential adverse effects on the breastfed infant from LUNESTA or from the underlying maternal condition.

Pediatric Use

Safety and effectiveness of LUNESTA have not been established in pediatric patients. LUNESTA failed to demonstrate efficacy in controlled clinical studies of pediatric patients with Attention-Deficit/Hyperactivity (ADHD) associated insomnia.

In a 12-week controlled study, 483 pediatric patients (aged 6-17 years) with insomnia associated with ADHD (with 65% of the patients using concomitant ADHD treatments) were treated with oral tablets of LUNESTA (1 or 2 or 3 mg tablets, n=323), or placebo (n=160). LUNESTA did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 12 weeks of treatment. Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse reactions observed with LUNESTA versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%). Nine patients on LUNESTA (3%) discontinued treatment due to an adverse reaction compared to 3 patients on placebo (2%).

In studies in which eszopiclone (2 to 300 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, neurobehavioral impairment (altered auditory startle response) and reproductive toxicity (adverse effects on male reproductive organ weights and histopathology) were observed at doses ≥ 5 mg/kg/day. Delayed sexual maturation was noted in males and females at ≥10 mg/kg/day. The no-effect dose (2 mg/kg) was associated with plasma exposures (AUC) for eszopiclone and metabolite (S)-desmethylzopiclone approximately 2 times plasma exposures in humans at the maximum recommended dose (MRHD) in adults (3 mg/day).

When eszopiclone (doses from 1 to 50 mg/kg/day) was orally administered to young dogs from weaning through sexual maturity, neurotoxicity (convulsions) was observed at doses ≥ 5 mg/kg/day. Hepatotoxicity (elevated liver enzymes and hepatocellular vacuolation and degeneration) and reproductive toxicity (adverse effects on male reproductive organ weights and histopathology) were noted at dose ≥10 mg/kg/day. The no-effect dose (1 mg/kg) was associated with plasma exposures (AUC) to eszopiclone and (S)-DMZ approximately 3 and 2 times, respectively, plasma exposures in humans at the MRHD in adults.

Geriatric Use

A total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. The overall pattern of adverse events for elderly subjects (median age = 71 years) in 2-week studies with nighttime dosing of 2 mg eszopiclone was not different from that seen in younger adults . LUNESTA 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population. Compared with non-elderly adults, subjects 65 years and older had longer elimination and higher total exposure to eszopiclone. Therefore, dose reduction is recommended in the elderly patients .

Hepatic Impairment

No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. Exposure was increased in severely impaired patients compared with the healthy volunteers. The dose of LUNESTA should not exceed 2 mg in patients with severe hepatic impairment. LUNESTA should be used with caution in patients with hepatic impairment .

Every evening, millions of Americans use a prescription drug to help them get to sleep and stay asleep, usually a generic version of Ambien (zolpidem), Sonata (zaleplon), or Lunesta (eszopiclone). These three medications are all so-called “z-drugs”: non-benzodiazepine drugs that induce sleep by causing a sort of hypnotic, calming effect. They’re considered safer to use than the benzodiazepine drugs, which have a higher risk of dependence and overdose.

How effective are these sleep drugs, anyway, and who do they work for best? It’s a straightforward question, but answering it isn’t so simple.

What do everyday people say?

Our friends at Iodine collected data about the real-life experiences of people taking these drugs. Data comes from hundreds of people sharing their experiences with Ambien, Lunesta, and Sonata, and rating these drugs in three respects:

  1. How well they thought the drug worked
  2. How much of a hassle the drug created in terms of side effects and other challenges
  3. How satisfied they were with the drug (a “worth it” score)

First, younger people are less satisfied with sleep medications and find them to be more of a hassle in terms of side effects, and older people find sleep drugs to work better with fewer side effects.

And then there’s the bottom line: which drug works best.

Iodine data shows a clear preference for Ambien (zolpidem) in terms of overall satisfaction (“worth it” score). People taking Ambien say it’s worth it 67% of the time, while those taking Lunesta (eszopiclone) say it’s worth it 55% of the time, and those taking Sonata (zaleplon) say it’s worth it 42% of the time.

That still leaves a lot of people unsatisfied with these sleep medications, meaning lots of people are still going to struggle with insomnia—even with medications.

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What do clinical studies say?

The above results show us that most of the people surveyed were satisfied with Ambien, but we still haven’t discussed dosage. That’s where clinical studies might be helpful. A study from Japan, for example, compared eszopiclone (Lunesta) to zolpidem (Ambien) and found that at doses of 2 mg or higher, these drugs were equally effective at helping people fall asleep. However, eszopiclone (Lunesta) was more effective in overall sleep efficiency (defined as the percentage of time people stayed asleep).

But, the effect depended entirely on dose. At lower doses of 1 mg, eszopiclone’s advantage disappeared. That’s important because the FDA reduced the recommended dose for eszopiclone from 2 mg to 1 mg, following reports that people on higher doses were less alert in the morning and at a higher risk of drowsiness during activities such as driving a car. This followed an earlier FDA adjustment in the recommended dose for zolpidem in women from 10 mg to 5 mg.

Keep in mind: Studies on sleep medications are usually done in sleep laboratories, which are poor proxies for real life, and they normally only include a small number of people over one or two nights because these types of studies are expensive. It’s difficult to apply the results from clinical trials to real life, and your best bet is to discuss treatment options with a healthcare professional and to keep your doctor in the loop as you try any new drug.

How much do these drugs cost?

At GoodRx, the lowest price for the generic version of Ambien, zolpidem, is around $8 for a prescription of thirty 10 mg tablets. The lowest GoodRx price for zaleplon (generic Sonata) is about $14 for a similar prescription. Eszopiclone (generic Lunesta) is around the same price.

Considering that people report greater satisfaction with zolpidem than the others, it looks like the cheapest drug might also be the one people prefer most. In other words, Ambien (zolpidem) offers the best bang for the buck.

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      • 10 Steps to Take if an Addict or Alcoholic Refuses Treatment
      • What Are the Health Effects of Teen Substance Abuse?

    Zolpidem (Ambien)& Eszopiclone (Lunesta): What Is Less Addictive?

    Unfortunately, both zolpidem (Ambien) and eszopiclone (Lunesta) can be addictive, especially if abused. The question of which one is more or less addictive, however, is difficult to answer. Like almost every aspect of the disorder of addiction, it is a deeply personal experience. That is, different people will experience the drugs differently. Some will develop an addiction to Lunesta after using Ambien without incident, and vice versa.

    For those who are concerned about the potentially addictive nature of either drug, it is important to know the facts, maintain open communication with the prescribing physician, and report any unusual symptoms or concerns.

    Zolpidem (Ambien) & Eszopiclone (Lunesta) is Prescribed For

    Zolpidem or, Ambien, is prescribed to treat insomnia, or the issue of having a hard time falling or staying asleep throughout the night. It is a sedative-hypnotic drug that works by slowing down the brain’s functions, allowing the brain and the body to relax and go to sleep.

    Lunesta or, Eszopiclone, is prescribed for the treatment of insomnia, for those who experience difficulties falling asleep or staying asleep. It is classified as a hypnotic medication that works by slowing down the brain’s function, which in turn allows the brain and body to rest.

    What are Side Effects of Using Zolpidem (Ambien)

    There are a number of potential side effects that can occur when taking Ambien. Some of the milder effects may pass as the body adjusts to the medication, but if they persist, it is important to call the prescribing doctor. Severe or life-threatening side effects require immediate medical treatment.

    Serious side effects that may require medical attention and care may include:

    • Itching, hives, or rash
    • Swelling of the lips, face, tongue, throat, or eyes
    • Difficulty swallowing
    • Difficulty breathing
    • Hoarseness
    • Nausea and vomiting
    • Shortness of breath
    • Chest pain
    • Pounding heartbeat
    • Problems with vision

    What are Side Effects of Using Eszopiclone (Lunesta)

    Mild to severe side effects may occur in some people who take Lunesta. For some, the symptoms are mild and only occur when the patient is adjusting to the medication, but for others, they may persist. Moderate to severe side effects should be reported to the prescribing doctor, and the patient should seek immediate emergency care. Serious side effects may include:

    • Itching, rash, and/or hives
    • Swelling of the extremities, face, tongue, eyes, throat, and/or lips
    • Difficulty swallowing or breathing
    • Hoarseness

    Zolpidem (Ambien) & Eszopiclone (Lunesta) Special Precautions

    Users of Ambien may experience a “waking sleep,” in which they engage in activities, such as driving, eating, having sex, engaging in conversation, or otherwise being active and ambulatory as if they are awake when they are in fact asleep. They often have no memory of what occurred the next morning. This can be extremely dangerous, and patients who believe that this is happening to them should contact their doctor.

    Users of Lunesta have reported engaging in activities while under the influence of the drug, but waking without memory of those events. Behaviors can include making and preparing food, having sex, having conversations, driving a car, and more. If this occurs, patients are encouraged to contact the prescribing physician right away.

    Zolpidem (Ambien) & Eszopiclone (Lunesta) Abuse

    It is possible to abuse Ambien. Taking more than is prescribed, taking doses too close together, or using other drugs in combination with Ambien – including over-the-counter sleeping pills, prescription drugs, or illicit substances including alcohol – can put a person at extreme risk. Overdose is a possibility, as is fatality due to accident under the influence.

    Abuse of Lunesta can occur if the person takes the drug outside the bounds of a prescription. That is, if the drug is taken without a personal prescription or if the patient takes more than prescribed, then they may be at an increased risk of overdose or accident under the influence. If the patient mixes Lunesta with alcohol, OTC sleep medications, painkillers, or other illicit substances, risk of medical emergency and/or fatality increases further.

    Zolpidem (Ambien) Addiction

    Ambien addiction is rare, but it does occur. It is possible to feel both physically and psychologically dependent on the drug, feeling as if it is impossible to function without it despite negative consequences that may occur and risks that may develop. If this occurs, treatment is needed.

    Eszopiclone (Lunesta) Addiction

    It is rare but possible to become addicted to Lunesta. Physical and psychological dependence (e.g., cravings) define addiction. If the individual is unable to moderate or stop using the drug despite negative consequences and risks, then treatment is recommended.

    For those who are addicted to Lunesta or Ambien, medical detox followed by intensive therapeutic treatment with an addiction focus as well as a focus on holistic methods of managing the sleep disorder can help.

    Two medications commonly used to treat insomnia or sleep disturbances are Ambien and Lunesta. These were developed as safer alternatives to benzodiazepine medications like Ativan or Valium, which can become addictive after two weeks. These medications are sedative-hypnotics, meaning they slow the activity of the brain enough to allow the person to fall asleep; they do not force a person to fall asleep or pass out. Both medications, however, are associated with a potential for substance abuse.

    Ambien

    This is the brand name for the sedative-hypnotic sleep medication, zolpidem.

    What are the signs of Ambien addiction?

    Ambien can be addictive for some people. Signs of addiction include escalating the dose without consulting a doctor; compulsively ingesting the drug, even when attempting to stop taking it; taking the drug for euphoric effects rather than as a medical treatment; needing more to achieve the original effect; lying about the dose or becoming defensive when asked about it; “doctor-shopping” to get more Ambien; worrying about the next dose and obsessing about taking Ambien; and maintaining a large supply of the drug.

    What are Ambien’s side effects?

    Ambien can cause several side effects even when used as prescribed. These include:

    • Short-term memory problems
    • Anxiety
    • Somnolence, or falling asleep during the day
    • Impaired driving or other activities
    • Abnormal thoughts or behaviors, including increased aggression, abnormal extroversion, hallucinations, worsening mood disorders like depression, agitation, or suicidal thoughts
    • Parasomnias: walking, talking, eating, driving, or having sex while asleep

    The most dangerous of these side effects are the parasomnias, especially sleep-driving. However, there are other, more common side effects which are less dangerous, including:

    • Fatigue or drowsiness
    • Headache
    • Diarrhea
    • Feeling “drugged”
    • Dizziness
    • Nausea or appetite changes

    Are there risks of long-term use?

    People who take Ambien for a long time are at greater risk of tolerance, dependence, and addiction. These conditions can lead to withdrawal symptoms that may be very uncomfortable and lead to relapse or overdose.

    Long-term abuse of the substance can lead to cognitive changes, including slowed reaction time and thinking. The person may sleep excessively due to exhaustion induced by the drug. They may be less able to drive, perform job activities, complete schoolwork, or perform other actions that require physical coordination.

    People who struggle with long-term abuse of Ambien are also at risk of developing digestive problems and damaging their liver.

    Lunesta

    Like Ambien, Lunesta is a sedative-hypnotic used in the short-term treatment of insomnia. It was developed as a safer alternative to benzodiazepines; however, the drug can lead to addiction and side effects. Lunesta is the most popular brand name of the generic medication, eszopiclone.

    Are there safer drug alternatives to Lunesta?

    There are not many prescription alternatives to Lunesta that are safer or more effective. Ambien is a similar medication; benzodiazepines have been prescribed as short-term treatments for insomnia as well. These drugs are all very habit-forming and potentially addictive, so ultimately, a person must discuss their prescription with their doctor to determine if the medication is safe, especially if the person has a history of substance abuse.

    Insomnia may have an underlying physical or psychological cause. If the person continues to suffer from insomnia after they have finished their Lunesta prescription, it is possible that an underlying mental or physical health issue is the cause.

    Sometimes, over-the-counter sleep medications can be as effective as Lunesta, with less risk of dependence or addiction. Herbal supplements like Valerian root can relax a person enough to rest, but these substances can interact with many prescription medications. Other sleep aids may include antihistamines, which are also used to treat allergies, so do not take these drugs when also taking antihistamines for allergies or another condition.

    Can you overdose on Lunesta?

    It is possible to overdose on Lunesta, although there are not as many symptoms associated with overdose as with other drugs. The main two symptoms include intense drowsiness while awake; if the person is asleep, they may have overdosed if they cannot be woken up. Call 911 to get emergency medical attention for someone who may have overdosed on Lunesta.

    Can Lunesta cause withdrawal symptoms?

    When a person stops taking Lunesta, especially if they struggle with addiction to this medication, they may experience withdrawal symptoms. The most common symptom is rebound insomnia. Other symptoms include:

    • Anxiety
    • Unusual dreams or nightmares
    • Stomach cramps
    • Muscle pain
    • Nausea or vomiting
    • Weakness
    • Shakiness
    • Seizures (very rare)

    Prescription Drug Categories

    • Opiates
    • Benzodiazepines
    • Stimulants
    • Barbiturates

    Lunesta (Eszopiclone) And Alcohol – The Dangers And Effects Of Mixing

    Trusted Content

    Medically reviewed by

    Dr. Gerardo Sison, Pharm.D

    Revised on September 27, 2019

    Lunesta (eszopiclone) and alcohol both slow down functions in the body, and can be dangerous when combined. Drinking alcohol while taking Lunesta can increase the risk for overdose and be a sign of substance abuse.

    Lunesta, the brand name for eszopiclone, is a prescription sedative used to treat insomnia. Comparable to drugs such as Ambien (zolpidem) and Sonata (zaleplon), Lunesta is a fast-acting drug capable of helping people fall asleep quickly and stay asleep.

    However, Lunesta can also have some concerning side effects, such as sleep-walking and lasting drowsiness. Drinking alcohol while taking Lunesta can increase the risk for these effects, as well as several other potential dangers that in severe cases can be lethal.

    Although some people who drink alcohol while taking Lunesta may be unaware of the dangers, mixing the two substances is also a sign of drug abuse and addiction. If you or someone you know is struggling with an addiction to alcohol and Lunesta, addiction treatment may be needed.

    What Are The Side Effects Of Drinking While Taking Lunesta?

    Lunesta and alcohol belong to a category of substances known as central nervous system (CNS) depressants. This means that they both slow, or depress, functions in the body that are controlled by the central nervous system. This includes cognitive functions such as concentration, as well as physical reflexes and movement.

    When taken together, the individual effects of these drugs can become even more intense. In the case of alcohol and Lunesta, this can be dangerous, leading to extreme sedation and other potentially life-threatening symptoms.

    The most common side effects that can occur from mixing alcohol and Lunesta include:

    • drowsiness
    • decreased coordination
    • slowed or difficulty breathing
    • lack of control over reflexes or movements
    • memory problems
    • confusion
    • bizarre behavior
    • aggression
    • depression
    • suicidal thoughts
    • hallucinations
    • loss of consciousness
    • coma

    The likelihood of experiencing these side effects can depend on the dose of Lunesta taken and the amount of alcohol consumed. Other factors such as older age, having a history of substance abuse, and other medical conditions may increase the chance of negative side effects.

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    Why Would Someone Mix Lunesta And Alcohol?

    In some cases, people who are taking Lunesta may be unaware of the side effects of drinking alcohol while taking the drug. Others may mix the two if they feel that Lunesta alone isn’t strong enough to help them fall asleep.

    Combining sleeping pills with alcohol can also be a sign of drug abuse. This is more common among people who struggle with addiction, as mixing the two can make their combined effects stronger than taking one or the other alone.

    In addition to its primary effect of drowsiness, high doses of Lunesta may cause euphoria and hallucinations. Mixing it with alcohol may increase the chance of experiencing these symptoms and make them more intense.

    Dangers Of Mixing Lunesta And Alcohol

    Sleeping pills like Lunesta are listed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as drugs that can have harmful interactions with alcohol. Due to this, the FDA advises against drinking alcohol while taking Lunesta.

    The most immediate danger of mixing alcohol with Lunesta is the high risk for overdose. This can lead to serious health complications without treatment, including death.

    Other dangers of mixing Lunesta with alcohol include:

    • amnesia
    • engaging in risky behaviors while only half-awake
    • increased suicide risk
    • drug abuse and addiction

    Memory Problems

    One of the side effects that can occur when taking Lunesta is memory impairment or amnesia. This is most common among people who either do not go to bed after taking the drug or take a dose of 2 milligrams (mg) or higher.

    Mixing alcohol with Lunesta can worsen or increase the chance of memory problems. People who mix alcohol with Lunesta may experience blackouts or be unable to recall events that occurred after consuming taking the two substances.

    High-Risk Behaviors

    In 2014, the FDA issued a drug safety statement reporting that people who take Lunesta dosages of 2 mg or more may be at risk for engaging in activities while only half-awake.

    The most common sleepwalking activities reported by those taking Lunesta include:

    • ‘sleep-driving’ (driving while not fully awake)
    • holding conversations
    • making phone calls
    • having sex
    • eating food
    • unsafe use of the kitchen stove

    The FDA reported just earlier this year that this effect has led to serious injuries among people who take the drug. The federal agency is therefore now requiring that a warning about this risk be listed on prescription labels for Lunesta and other drugs for insomnia.

    The most common consequences that have occurred as a result of this side effect include burns, falls, vehicle collisions, near-drowning, and suicide attempts.

    Drinking while taking Lunesta may increase the chance of engaging in these sleep-walking behaviors and cause dangerously impaired judgment capable of leading to injury.

    Increased Risk For Overdose

    Lunesta overdose can occur after taking excessive doses of Lunesta but is rarely life-threatening on its own. Alcohol, however, can not only increase the risk for Lunesta overdose but also make it more likely to result in deadly consequences.

    Mixing alcohol and Lunesta can have serious consequences on breathing, heart function, and lead to unconsciousness or coma. If you suspect that someone you know has overdosed on Lunesta after drinking alcohol, call 9-1-1 or seek emergency medical assistance right away.

    Suicide Risk

    Lunesta has the potential to worsen depression in people with a history of depression or suicidal thoughts. Alcohol abuse can also lead to mood problems like depression as a result of alcohol’s effects on the brain or the strain of struggling with addiction.

    Mixing the two can worsen their mood-altering effects and increase the risk of suicide.

    Polysubstance Abuse And Addiction

    Drinking alcohol while abusing Lunesta is a sign of polysubstance abuse, which is a term defined as abusing one or more substances at the same time.

    Millions of people across the United States are estimated to have a serious drug or alcohol problem in any given year, and this includes medications that have been prescribed by a doctor.

    Mixing prescription sleeping pills with alcohol can have a significant impact on a person’s life, affecting relationships, ability to work, and general wellbeing. Drug abuse tends to become worse over time and may lead to physical dependence and addiction.

    Polysubstance abuse affects people of all ages and can have devastating consequences. The most effective way to overcome an addiction to Lunesta and alcohol is to seek professional treatment.

    Treatment For Polysubstance Abuse

    Abusing alcohol and sleeping pills is not a simple problem, and requires more than a simple solution. Chronic abuse of these substances can often lead to dependence, making it difficult for someone to stop using them all at once.

    The first step for treating dependence on Lunesta and alcohol is to undergo detox. Alcohol and drug detox can be an uncomfortable process and sometimes dangerous. The safest and most effective option for avoiding relapse and health risks is to enter a medical detox program.

    Our treatment programs at Addiction Campuses provide a wide array of inpatient and outpatient treatment services that can be effective for people struggling with drug and alcohol problems. This includes medically supervised detox services and behavioral treatment such as individual counseling and group therapy.

    If you or someone you know is struggling with polysubstance abuse, don’t wait to reach out for help. Contact us today to learn more about Addiction Campuses’ treatment programs for overcoming Lunesta and alcohol abuse.

    Written by Addiction Campuses Editorial Team

    © 2020 AddictionCampuses.com. All rights reserved.

    This page does not provide medical advice.

    Article Sources

    U.S. Food and Drug Administration (FDA) –

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