- Why anesthetics cause prolonged memory loss
- Public Information
- Ontario’s Narcotics Strategy
- Pro and con Midazolam is the sedative of choice to supplement narcotic anesthesia: Pro: Midazolam Is the Sedative of Choice to Supplement Narcotic Anesthesia
- What is Versed?
- Important Information
- Before taking this medicine
- How should I take Versed?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking Versed?
- Versed side effects
- What other drugs will affect Versed?
- Further information
- More about Versed (midazolam)
- Effects of Benzodiazepines After Procedures in Elderly Patients
- Midazolam Injection
- Midazolam Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- More about midazolam
Versed is one of several brand names of the drug midazolam, which is given before and during surgeries and some medical procedures to induce drowsiness, relieve anxiety, and prevent remembering the event.
The drug is also used to cause a loss of consciousness during surgery or when a seriously ill person’s breathing is assisted by a ventilator.
Midazolam may also be used to treat insomnia and seizures in children.
Midazolam belongs to a group of drugs known as benzodiazepines, or central nervous system depressants.
The Food and Drug Administration (FDA) approved midazolam in 1985. It’s only given by or under the supervision of a doctor who’s trained to use it.
Midazolam comes as a tablet, syrup, or injectable solution. Children having surgery typically take the oral syrup.
Midazolam may cause serious breathing problems that could lead to permanent brain injury or death. You should only receive this medicine if your doctor has equipment to monitor your heart and lungs and provide life-saving medical treatment immediately if your breathing stops.
You should tell your physician if you have a severe infection or if you have or have ever had:
- Lung, airway, or breathing problems
- Heart disease
- Kidney disease
- Liver disease
Also, tell your doctor if you are taking any of the following medicines before receiving midazolam:
- Barbiturates such as secobarbital (Seconal)
- Droperidol (Inapsine)
- Medications for anxiety, mental illness, or seizures
- Narcotic medications for pain such as fentanyl (Actiq, Duragesic, Sublimaze), meperidine (Demerol), and morphine (Avinza, Kadian, MS Contin, and others)
- Sleeping pills
You should also alert your physician if you have ever used street drugs or abused prescription medications.
Tell your physician if you have recently stopped drinking large amounts of alcohol before taking this medicine.
You shouldn’t receive midazolam if you have glaucoma (eye conditions, including increased pressure within the eye, that cause damage to the optic nerve and possibly vision loss).
Older adults should receive lower doses of midazolam, as higher doses are more likely to cause serious side effects in people age 65 or older.
If you receive repeated midazolam injections in the intensive care unit (ICU) for a long period of time, you may become dependent on it. Your doctor will probably gradually reduce the drug dosage until it is discontinued entirely to prevent withdrawal symptoms.
Pregnancy and Midazolam
Midazolam is a Pregnancy Category D drug, which means it could harm an unborn baby. You shouldn’t be given this medicine while you are pregnant.
The drug can also pass into breast milk and may harm a breastfeeding baby. Tell your physician if you are breastfeeding before receiving Versed.
Why anesthetics cause prolonged memory loss
Until now, scientists haven’t understood why about a third of patients who undergo anesthesia and surgery experience some kind of cognitive impairment — such as memory loss — at hospital discharge. One-tenth of patients still suffer cognitive impairments three months later.
Anesthetics activate memory-loss receptors in the brain, ensuring that patients don’t remember traumatic events during surgery. Professor Beverley Orser and her team found that the activity of memory loss receptors remains high long after the drugs have left the patient’s system, sometimes for days on end.
Animal studies showed this chain reaction has long-term effects on the performance of memory-related tasks.
“Patients — and even many doctors — think anesthetics don’t have long-term consequences. Our research shows that our fundamental assumption about how these drugs work is wrong,” says Orser, a Professor in the Departments of Anesthesia and Physiology, and anesthesiologist at Sunnybrook Health Sciences Centre.
In the study — led by PhD candidate Agnes Zurek — the team gave healthy male mice a low dose of anesthetic for just 20 minutes and found that receptor activity was increased for a week afterwards. These results suggest the same effect can impact a patient’s learning and memory during a time when they are receiving critical information about their care.
“There’s a lot going on after surgery, which can alter our ability to think clearly. Loss of sleep, new environments and medications can all impact a patient’s mental function. Anesthetics likely compound these issues,” says Orser.
She recommends physicians and family members carefully monitor patients after surgery for any signs of memory loss. “Patients should write everything down or have a second pair of ears with them after surgery. For high-risk groups, physicians need to inform patients about these possible side effects and help manage the impact on recovery and overall health,” says Orser.
The likelihood of a patient experiencing cognitive impairment depends on their age, health, type of surgery and the anesthetic, with chances increasing for more intricate procedures. The incidence is highest in the elderly or those undergoing major surgery such as cardiopulmonary bypass.
“Anesthetics don’t put you to sleep — they induce a pharmacological coma. We shouldn’t take these drugs lightly,” Prof. Orser cautions.
Orser and her team are looking at drugs that can stop the receptors and restore memory loss. While they are still in the early stages of research, they say some of the drugs show very promising results in animal studies.
The study was published in the Journal of Clinical Investigation.
People who are put under general anesthesia may wind up with memory and cognitive deficits for days or weeks after surgery. But now, a new study in mice reveals a possible way to reverse the ill effects of anesthesia drugs on memory.
In the study, scientists gave mice a common anesthetic, and found the drug caused memory impairments that lasted up to a week. But when they gave the mice another drug, after the anesthetic, the memory effects were reversed, the researchers say.
The findings suggest that doctors should tell their patients that anesthesia may affect their memory, said Dr. Beverly Orser, a professor of anesthesiology at the University of Toronto, in Canada, co-author of the study published today (Nov. 3) in The Journal of Clinical Investigation.
“It’s assumed that once the drugs are eliminated, our memories are going to go back to normal,” Orser told Live Science. “But when we test patients before and after a surgical procedure, a large number exhibit deficits in memory performance.”
Patients shouldn’t avoid undergoing necessary surgical procedures, but should be aware of the anesthetic’s potential effects, said Orser, who is a practicing anesthesiologist at Sunnybrook Health Science Centre in Toronto. “Everything’s a balanced risk,” she said.
About 37 percent of young adults and 41 percent of elderly patients who undergo surgery with anesthesia still have cognitive deficits when they’re discharged from the hospital, studies suggest. And for 6 percent of young adults and 13 percent of elderly adults, the problems persist about three months later.
“We all have stories where Grandma was never quite right after surgery,” Orser said.
Orser and her colleagues set out to measure how one common anesthetic affected memory in mice, as a model for humans. In mice, the researchers could study the effects of anesthesia without doing surgery, which would be unethical in humans, Orser said.
In one experiment, the researchers gave mice a low dose of the common anesthetic called etomidate, which works by binding to receptors on an animal’s brain cells called GABAARs.
When the anesthesia wore off, Orser and her team tested the mice’s memory with an examination that Orser called the “little red sports car test.”
Like humans, mice crave novelty. The researchers put the mice in an enclosure with two different objects, which the animals could explore. They then put the mice in an environment where one of the two objects was familiar, while the other was new. If the mice remembered the familiar object, they would spend more time around the novel one.
The old seems new again
After receiving the anesthetic, the mice spent roughly equal time around the familiar and the novel objects, suggesting their memory of the object was impaired. What’s more, these memory deficits lasted up to a week, Orser said.
In previous studies, the researchers found that mice that were given an electric shock in a certain environment would not act afraid of the environment if they had been given the anesthetic drug, Orser said.
But the researchers also found the memory effects appeared to be reversible. When the researchers gave the mice a drug that blocked the receptors targeted by the anesthetic, the animals performed as well in the novelty task as did animals that had not received any anesthetic.
While such drugs may be years away from being used in humans, they show promise for minimizing the cognitive effects of anesthesia, Orser said.
Follow Tanya Lewis on Twitter and Google+. Follow us @livescience, Facebook & Google+. Original article on Live Science.
Before your child receives midazolam,
- tell your child’s doctor and pharmacist if he or she is allergic to midazolam, any other medications, or cherries.
- tell your child’s doctor if your child is taking certain medications for human immunodeficiency virus (HIV) including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), fosamprenavir (Lexiva), indinavir (Crixivan),lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus). Your child’s doctor may decide not to give midazolam to your child if he or she is taking one or more of these medications.
- tell your child’s doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements your child is taking or plans to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Cordarone, Pacerone); aminophylline (Truphylline); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); certain calcium channel blockers such as diltiazem (Cartia, Cardizem, Tiazac, others) and verapamil (Calan, Isoptin, Verelan, others); cimetidine (Tagamet); clarithromycin (Biaxin); dalfopristin-quinupristin (Synercid); erythromycin (E-mycin, E.E.S.); fluvoxamine (Luvox); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); methylphenidate (Concerta, Metadate, Ritalin, others); nefazodone; ranitidine (Zantac); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane). Your child’s doctor may need to change the doses of your child’s medications or monitor your child carefully for side effects. Many other medications may also interact with midazolam, so be sure to tell your child’s doctor about all the medications your child is taking, even those that do not appear on this list.
- tell your child’s doctor what herbal products your child is taking, especially St. John’s wort.
- tell your child’s doctor if your child has glaucoma. Your child’s doctor may decide not to give your child midazolam.
- tell your child’s doctor if your child has or has ever had kidney or liver disease.
- tell your child’s doctor if your child is or may be pregnant, or is breast-feeding.
- you should know that midazolam may make your child very drowsy and may affect his or her memory, thinking, and movements. Do not allow your child to ride a bicycle, drive a car, or do other activities that require him or her to be fully alert for at least 24 hours after receiving midazolam and until the effects of the medication have worn off. Watch your child carefully to be sure that he or she does not fall while walking during this time.
- you should know that alcohol can make the side effects of midazolam worse.
Ontario’s Narcotics Strategy
A number of prescription narcotics and other controlled substance medications are being monitored through the Narcotics Strategy.
Prescription narcotics are drugs commonly prescribed to relieve moderate to severe pain. A couple examples of common narcotic medications include:
- acetaminophen with codeine (Tylenol® 3)
- oxycodone (OxyNEO™)
Controlled substances are drugs listed under Canada’s Controlled Drugs and Substances Act. A few examples of controlled substance medications include:
- methylphenidate (Ritalin®)
- benzodiazepines (Valium®)
- barbiturates (Phenobarbital)
Here is a list of common medications being monitored under the strategy.
|Brand Name||Generic Name|
|tylenol no.3||acetaminophen compound with codeine|
|percocet||oxycodone hcl & acetaminophen|
|statex, ms contin||morphine sulfate|
|codeine, codeine contin||codeine sulfate|
|duragesic patch||fentanyl transdermal system|
|fiorinal||acetylsalicylic acid & butalbital & caffeine|
|suboxone||buprenorphine & naloxone|
|ralivia, ultram, zytram, tridural||tramadol|
|ritalin, concerta||methylphenidate hcl|
|adderall xr||amphetamine salts|
The complete list of monitored drugs includes:
- Controlled Drugs and Substances Act (Canada) – Schedules I – V. Learn more >>
Please speak with your doctor, dentist or pharmacist to see if any drugs you are currently taking are on the list.
Note: The medication lists provided here may change and will be updated from time to time.
For More Information
Pro and con
Midazolam is the sedative of choice to supplement narcotic anesthesia: Pro: Midazolam Is the Sedative of Choice to Supplement Narcotic Anesthesia
Having examined the options for adjuvant drug use during cardiac anesthesia, it becomes increasingly apparent that midazolam is “the drug” of choice and that supplementation with an opioid is an ideal adjuvant. In the hands of experienced cardiac anesthesiologists, the majority of the drugs discussed could provide adequate anesthesia with outcomes that would be difficult to distinguish, with the exception of awakening and time to extubation. Regardless of the inability to differentiate overall outcome, when comparing ease of providing complete “balanced” anesthesia, minimal cost increase, ease of use, hemodynamic stability, reliability of amnesia and ability to decrease narcotic requirement and allow early extubation, midazolam is a clear winner. Given as a continuous infusion or a bolus, potent opioids such as alfentanil, fentanyl or sufentanil enhance the amnestic and hypnotic effect of midazolam, decreasing the required dose. In addition, the combination of midazolam and narcotics decreases the catecholamine response that either one alone would produce. This removes the necessity of marked narcotic overdose required when narcotics alone are used. The result of this anesthetic combination is a technique that can be used in the majority of cardiac patients regardless of their ventricular performance, allowing options for earlier awakening, earlier extubation and decreased ICU stay.
The goal of complete “balanced” anestheisa is best achieved with continuous infusions of micazolam and opioids. Accepting recall of intraoperative events as a necessary evil is unacceptable in the stable cardiac surgery patient. Continous infusion of midazolam with narcotics reliably keeps patients unconscious, prevents recall, and provides a consistent, dependable hypnotic/amnestic foundation upon which opioid analgesia can be added to build a complete anesthetic.
Generic Name: midazolam (oral) (mye DAZ oh lam)
Brand Name: Versed
Medically reviewed by Drugs.com on Nov 19, 2019 – Written by Cerner Multum
- Side Effects
What is Versed?
Versed is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) sedative.
Versed is used to sedate a person who is having a minor surgery, dental work, or other medical procedure.
Versed may also be used for purposes not listed in this medication guide.
Versed can slow or stop your breathing, especially if you have recently used a narcotic (opioid) medication. This medicine is given in a hospital, dentist office, or other clinic setting where your vital signs can be watched closely.
You should not take Versed if you have narrow-angle glaucoma, if you are allergic to cherries, or if you are allergic to this medicine or similar medicines (Valium, Xanax, Ativan, and others).
Do not drink alcohol for at least 24 hours after taking Versed.
Before taking this medicine
You should not take Versed if:
To make sure Versed is safe for you, tell your doctor if you have:
asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
kidney or liver disease;
congestive heart failure; or
if you also use a narcotic (opioid) medication.
Versed can cause birth defects in an unborn baby, and generally should not be used during pregnancy. Tell your doctor if you are pregnant.
Midazolam can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Versed?
Versed can slow or stop your breathing, especially if you have recently used a narcotic (opioid) medication. This medicine should be used only in a hospital, dentist office, or other clinic setting where any serious side effects can be quickly treated.
Versed is usually given as a single dose just before your surgery or procedure.
After you take Versed, you will be watched closely to make sure the medicine is working and does not cause harmful side effects.
Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are in surgery.
Versed can make you very drowsy, dizzy, or light-headed. These effects may last longer in older adults. Use caution to avoid falling or accidental injury after you have received this medicine injection. You may need help getting out of bed for at least the first 8 hours.
What happens if I miss a dose?
Because you will receive Versed in a clinical setting, you are not likely to miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of midazolam can be fatal.
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while taking Versed?
Do not drink alcohol for at least 24 hours after taking Versed. This medication can increase the effects of alcohol, which could be dangerous.
Grapefruit and grapefruit juice may interact with Versed and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking this medicine.
Versed injection can cause extreme drowsiness that may last for 24 hours after you have received the medication. Older adults may feel sleepy for even longer.
Avoid driving or doing anything that requires you to be awake and alert until the effects of Versed have worn off completely.
Versed side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers right away if you have:
cough, wheezing, trouble breathing, weak or shallow breathing;
slow heart rate;
a light-headed feeling, like you might pass out;
agitation, hostility, tremors; or
confusion, hallucinations, unusual thoughts or behavior.
The sedative effects of midazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking Versed.
Common side effects may include:
amnesia or forgetfulness after your procedure;
runny nose, sneezing; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Versed?
Shortly after you take Versed, taking other drugs that make you sleepy or slow your breathing can cause dangerous side effects. Tell your doctor if you regularly use a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Many drugs can interact with Versed. Not all possible interactions are listed here. Tell your doctor about all your current medicines, especially:
heart or blood pressure medicine;
antiviral medicine to treat hepatitis C or HIV/AIDS;
seizure medication; or
This list is not complete and many other drugs can interact with Versed. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 3.01.
More about Versed (midazolam)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Compare Alternatives
- Support Group
- 48 Reviews
- Drug class: benzodiazepines
- FDA Alerts (4)
- Versed injection
- Versed (Advanced Reading)
- Versed Injection (Advanced Reading)
Other brands: Nayzilam
- Midazolam Hydrochloride (AHFS Monograph)
- … +1 more
Related treatment guides
- ICU Agitation
- Light Anesthesia
- Light Sedation
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Isavuconazonium Sulfate
- Morphine Sulfate Liposome
- Opium Alkaloids
- Sodium Oxybate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Ginkgo Biloba
- St John’s Wort
Effects of Benzodiazepines After Procedures in Elderly Patients
to the editor: An independent 93-year-old woman had a successful corneal transplant but was convinced that her ophthalmologist had delegated the procedure to an associate. The ophthalmologist repeatedly identified himself before and during the surgery, but the patient could not recall these exchanges. Although she was told that temporary memory problems were associated with anesthesia, she developed exacerbated fears of becoming demented, lost self-confidence, and became withdrawn, depressed, and unable to care for herself. Eventually, the explanation that anesthetics can block memory formation enabled her to talk about the profound impact of this “minor” side effect; however, she only gradually regained her previous independence.
Memory loss is a major concern of the elderly. Even slight or temporary loss of memory can disrupt the fine balance between independence and disability. Any erosion of self-confidence can lead to depression, noncompliance, and morbidity. In this case, the relatively minor and well-recognized effect of benzodiazepine on memory resulted in serious consequences.
An increasing number of elderly patients undergo “minor surgeries.”1 Short-acting benzodiazepines have significant advantages over general anesthesia. Amnesia of the events surrounding the surgery is generally considered an enhancement of their sedative and anxiolytic properties.
Significant functional deterioration is frequently observed after apparently “minor” surgery in elderly patients. Some of these cases may relate to the use of amnesic benzodiazepines. Both pharmacokinetic and pharmacodynamic studies suggest that the effects of short-acting benzodiazepines may be potentiated in the elderly through age-related reduction in metabolism and changes in the submit makeup of the g amino butyric acid (GABAA) receptor. Age-related increases in the alpha1 submit of the GABAA receptor in hippocampus have been reported.2 Studies3,4 suggest an age-related increase in the amnestic action of nonselective benzodiazepines. An age-related, 50 percent reduction in the EC50 for the sedative hypnotic effects of midazolam (Versed) in humans has been reported.5 The half-life of midazolam is approximately doubled in elderly patients and may be further influenced by obesity, renal, cardiac or hepatic conditions and certain drugs including central nervous system depressants, alcohol, cimetidine (Tagamet), verapamil (Calan), erythromycin, and diltiazem (Cardizem).6
Short-acting benzodiazepines providing excellent conscious sedation, anxiolysis and amnesia for procedures, but may also have adverse effects that can be misinterpreted as cognitive decline. If elderly patients are not informed about the amnesic actions of these agents, they may have significant difficulty following surgery. The amnesic effects are selective in nature, which can distort reality and be disorienting to the patient, even cognitively intact persons.
We are not suggesting that the use of benzodiazepines is inappropriate in elderly patients, but we wish to strongly make two points. First, lower doses may be necessary in the elderly because of altered pharmacokinetic and pharmacodynamic properties. Second and, most important, the patient, family members, and caretakers should be prepared for the amnesic effects and appreciate the significance of these experiences for the elderly patient. Patients may need considerable reassurance and care to “get back to my usual feisty self” after apparently “minor” procedures.
See WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following IV and 10.8% of patients following IM administration) and apnea (15.4% of patients following IV administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube (eg, upper endoscopy and dental procedures).
The following additional adverse reactions were reported after intramuscular administration:
|headache (1.3%)||Local effects at IM Injection site|
| pain (3.7%)
muscle stiffness (0.3%)
Administration of IM midazolam to elderly and/or higher risk surgical patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression. In most of these cases, the patients also received other central nervous system depressants capable of depressing respiration, especially narcotics (see DOSAGE AND ADMINISTRATION).
The following additional adverse reactions were reported subsequent to intravenous administration as a single sedative/anxiolytic/amnestic agent in adult patients:
The following adverse events related to the use of IV midazolam in pediatric patients were reported in the medical literature: desaturation 4.6%, apnea 2.8%, hypotension 2.7%, paradoxical reactions 2.0%, hiccough 1.2%, seizure-like activity 1.1% and nystagmus 1.1%. The majority of airway-related events occurred in patients receiving other CNS depressing medications and in patients where midazolam was not used as a single sedating agent.
For information concerning hypotensive episodes and seizures following the administration of midazolam to neonates (see BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Other adverse experiences, observed mainly following IV injection as a single sedative/anxiolytic/amnesia agent and occurring at an incidence of < 1.0% in adult and pediatric patients, are as follows:
Respiratory: Laryngospasm, bronchospasm, dyspnea, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea.
Cardiovascular: Bigeminy, premature ventricular contractions, vasovagal episode, bradycardia, tachycardia, nodal rhythm.
Gastrointestinal: Acid taste, excessive salivation, retching.
CNS/Neuromuscular: Retrograde amnesia, euphoria, hallucination, confusion, argumentativeness, nervousness, anxiety, grogginess, restlessness, emergence delirium or agitation, prolonged emergence from anesthesia, dreaming during emergence, sleep disturbance, insomnia, nightmares, athetoid movements, seizure-like activity, ataxia, dizziness, dysphoria, slurred speech, dysphonia, paresthesia.
Special Senses: Blurred vision, diplopia, nystagmus, pinpoint pupils, cyclic movements of eyelids, visual disturbance, difficulty focusing eyes, ears blocked, loss of balance, light-headedness.
Integumentary: Hive-like elevation at injection site, swelling or feeling of burning, warmth or coldness at injection site.
Hypersensitivity: Allergic reactions including anaphylactoid reactions, hives, rash, pruritus.
Miscellaneous: Yawning, lethargy, chills, weakness, toothache, faint feeling, hematoma.
Drug Abuse And Dependence
Midazolam is subject to Schedule IV control under the Controlled Substances Act of 1970.
Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs.
Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam.
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. There is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient’s needs. In some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days.
Read the entire FDA prescribing information for Midazolam Injection (Midazolam)
Midazolam Side Effects
Medically reviewed by Drugs.com. Last updated on Feb 15, 2019.
- Side Effects
Commonly reported side effects of midazolam include: apnea and bradypnea. Other side effects include: variable blood pressure. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to midazolam: injection solution
Other dosage forms:
- oral syrup
Injection route (Solution)
Midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Use only in settings that can provide for continuous monitoring of respiratory and cardiac function. The initial dose and all subsequent doses should always be titrated slowly. Midazolam injection should not be administered by rapid injection in the neonatal population as severe hypotension and seizures have been reported.
Along with its needed effects, midazolam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking midazolam:
- decreased awareness or responsiveness
- decreased urine output
- difficulty walking, speaking, or writing
- feeling sad or empty
- lack of appetite
- loss of bladder or bowel control
- loss of consciousness
- loss of interest or pleasure
- memory loss
- muscle twitching
- nightmares or unusually vivid dreams
- rapid weight gain
- severe sleepiness
- strong urge to urinate
- swelling of the face, ankles, or hands
- trouble concentrating
- trouble sleeping
- troubled breathing
- unable to speak
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Some side effects of midazolam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Muscle stiffness
For Healthcare Professionals
Applies to midazolam: compounding powder, injectable solution, intravenous solution, nasal spray, oral syrup
The most commonly reported side effects with oral formulations include emesis and nausea. Decreased tidal volume/respiratory rate and apnea were most commonly reported with parenteral formulations.
Very common (10% or more): Respiratory adverse events (up to 11%)
Common (1% to 10%): Respiratory depression, hypoxia, laryngospasm, upper airway obstruction, rhonchi, congestion
Uncommon (0.1% to 1%): Sneezing/rhinorrhea
Frequency not reported: Apnea, hypercarbia, desaturation, stridor, hiccough
Very common (10% or more): Decreased tidal volume/respiratory rate (up to 23.3%), apnea (up to 15.4%)
Common (1% to 10%): Hiccoughs, coughing, desaturation
Very rare (less than 0.01%): Dyspnea, hiccup, laryngospasm, respiratory arrest
Frequency not reported: Respiratory depression
Postmarketing reports: Bronchospasm, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea, dysphonia, yawning, continued phonation
Respiratory adverse events included hypoxia, laryngospasm, rhonchi, coughing, respiratory depression, airway obstruction, upper airway congestion, and shallow respirations; these side effects occurred more frequently at higher doses.
Decreased tidal volume/respiratory rate occurred in 23.3% of patients given IV formulations and in 10.8% of patients given IM formulations.
Apnea occurred in 15.4% of patients given IV formulations.
Very common (10% or more): Emesis/vomiting (up to 11%)
Common (1% to 10%): Nausea
Frequency not reported: Gagging, salivation
Common (1% to 10%): Nausea, vomiting
Very rare (less than 0.01%): Constipation, dry mouth
Postmarketing reports: Acid taste, excessive salivation, retching, toothache
Common (1% to 10%): Sedation/prolonged sedation, somnolence, depressed levels of consciousness
Frequency not reported: Drooling, dizziness, ataxia, vertigo, dysarthria, loss of balance
Common (1% to 10%): Headache, oversedation, drowsiness, seizure-like activity
Very rare (less than 0.01%): Movement disorder, ataxia, dizziness, seizure, anterograde amnesia
Frequency not reported: Involuntary movements, hyperactivity, decreased alertness, somnolence, prolonged/postoperative sedation, convulsions/drug withdrawal convulsions, feeling faint, tonic/clonic movements and muscle tremor
Postmarketing reports: Vasovagal episode, retrograde amnesia, grogginess, athetoid movements, lethargy, slurred speech, paresthesia, loss of balance, lightheadedness, feeling of burning, emergence delirium or agitation
Common (1% to 10%): Bradycardia, bigeminy
Frequency not reported: Increased heart rate, cardiac arrest, heart failure, decreased systolic and diastolic blood pressure
Common (1% to 10%): Hypotension
Very rare (less than 0.01%): Bradycardia, cardiac arrest, vasodilation
Frequency not reported: Thrombophlebitis, thrombosis, variations in blood pressure and pulse rate
Postmarketing reports: Bigeminy, premature ventricular contractions, tachycardia, nodal rhythm, hematoma, cardiovascular collapse, cardiovascular reactions, severe cardiorespiratory adverse events
Common (1% to 10%): IM injection site pain, IV site tenderness/pain during injection/redness/induration
Uncommon (0.1% to 1%): IM injection site induration/redness/muscle stiffness, IV site phlebitis
Frequency not reported: Injection site erythema, injection site pain
Postmarketing reports: Hive-like elevation at injection site, warmth or coldness at injection site
Common (1% to 10%): Agitation
Frequency not reported: Dysphoria, disinhibition, excitation, aggression, mood swings, hallucinations, confusion, inappropriate/adverse behavior, behavioral/emotional disorders, euphonia, libido disorders, restlessness, irritability, delusions, anger eruptions, nightmares, psychosis, physical dependency, withdrawal symptoms, abuse, depression (existing, unobserved depression)
Frequency not reported: Rage, excitement/paroxysmal excitement, abuse, physical drug dependence and withdrawal syndrome
Postmarketing reports: Argumentativeness, nervousness, anxiety, restlessness, sleep disturbance, insomnia, nightmares, dysphoria, irritability, tension, mood changes, dreaming during sleep
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus and urticaria
Frequency not reported: Angioedema
Postmarketing reports: Hives, rash, pruritus, skin reactions
Frequency not reported: Diplopia, strabismus, blurred vision
Common (1% to 10%): Nystagmus
Postmarketing reports: Blurred vision, diplopia, pinpoint pupils, visual disturbance, difficulty focusing eyes, cyclic movement of the eyelids
Frequency not reported: Fatigue, falls
Common (1% to 10%): Paradoxical reaction
Very rare (less than 0.01%): Fatigue, falls, assault/physical assault
Postmarketing reports: Prolonged emergence from anesthesia, blocked ears, chills, weakness, swelling, dreaming during emergence
Frequency not reported: Hypersensitivity
Frequency not reported: Hypersensitivity, anaphylactic shock
Postmarketing reports: Allergic reaction, anaphylactoid reactions
Frequency not reported: Muscle weakness, fractures
Frequency not reported: Fractures
1. Cerner Multum, Inc. “Australian Product Information.” O 0
2. “Product Information. Versed (midazolam).” Roche Laboratories, Nutley, NJ.
3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about midazolam
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Before receiving midazolam injection,
- tell your doctor and pharmacist if you are allergic to midazolam or any other medications.
- tell your doctor if you are taking certain medications for human immunodeficiency virus (HIV) including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), fosamprenavir (Lexiva), indinavir (Crixivan),lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus). Your doctor may decide not to give you midazolam injection if you are taking one or more of these medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: aminophylline (Truphylline); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); certain calcium channel blockers such as diltiazem (Cartia, Cardizem, Tiazac, others) and verapamil (Calan, Isoptin, Verelan, others); cimetidine (Tagamet); dalfopristin-quinupristin (Synercid); and erythromycin (E-mycin, E.E.S.). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with midazolam, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you have glaucoma (increased pressure in the eyes that may cause gradual loss of vision). Your doctor may decide not to give you midazolam injection.
- tell your doctor if you have recently stopped drinking large amounts of alcohol or if you have or have ever had kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
- talk to your doctor about the risks and benefits of receiving midazolam injection if you are 65 years of age or older. Older adults should usually receive lower doses of midazolam injection because higher doses are more likely to cause serious side effects.
- you should know that midazolam may make you very drowsy and may affect your memory, thinking, and movements. Do not drive a car or do other activities that require you to be fully alert for at least 24 hours after receiving midazolam and until the effects of the medication have worn off. If your child is receiving midazolam injection, watch him or her carefully to be sure that he or she does not fall while walking during this time.
- you should know that alcohol can make the side effects from midazolam injection worse.
- you should know that some studies in young children have raised concerns that repeated or lengthy use (>3 hours) of general anesthetic or sedation drugs such as midazolam in infants and children younger than 3 years of age or in women in the last few months of their pregnancy may affect the child’s brain development. Other studies in infants and toddlers show that a single, short exposure to anesthetic and sedation drugs is unlikely to have negative effects on behavior or learning. However, further research is needed to fully understand the effects of exposure to anesthesia on brain development in young children. Parents and caregivers of children younger than 3 years of age and pregnant women should talk to their doctors about the risks of anesthesia on brain development and appropriate timing of procedures that require general anesthetic or sedation medications.