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Midazolam marketed in English-speaking countries and Mexico under the trade names Dormicum,Hypnovel, and Versed,) is a short-acting drug in the benzodiazepine class developed by Hoffmann-La Roche in the 1970s. The drug is used for treatment of acute seizures, moderate to severe insomnia, and for inducing sedation and amnesia before medical procedures. It possesses profoundly potent anxiolytic, amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative properties.Midazolam has a fast recovery time and is the most commonly used benzodiazepine as a premedication for sedation; less commonly it is used for induction and maintenance of anesthesia.
Administration of midazolam by the intranasal or the buccal route (absorption via the gums and cheek) as an alternative to rectally administered diazepam is becoming increasingly popular for the emergency treatment of seizures in children.Midazolam is also used for endoscopy procedural sedation and sedation in intensive care. The anterograde amnesia property of midazolam is useful for premedication before surgery to inhibit unpleasant memories.Midazolam, like many other benzodiazepines, has a rapid onset of action, high effectiveness and low toxicity level. Drawbacks of midazolam include drug interactions, tolerance, and withdrawal syndrome, as well as adverse events including cognitive impairment and sedation. Paradoxical effects occasionally occur, most commonly in children and the elderly, particularly after intravenous administration.
Indications
Intravenous midazolam is indicated for procedural sedation (often in combination with an opioid, such as fentanyl), for preoperative sedation, for the induction of general anesthesia, and for sedation of ventilated patients in critical care units. Midazolam is superior to diazepam in impairing memory of endoscopy procedures, but propofol has a quicker recovery time and a better memory-impairing effect. It is the most popular benzodiazepine in the intensive care unit (ICU) because of its short elimination half-life, combined with its water solubility and its suitability for continuous infusion. However, for long-term sedation, lorazepam is preferred due to its long duration of action, and propofol has advantages over midazolam when used in the ICU for sedation, such as shorter weaning time and earlier tracheal extubation.
Pregnancy and breast feeding
Midazolam, when taken during the third trimester of pregnancy, may cause severe risk to the neonate, including benzodiazepine withdrawal syndrome, with possible symptoms including hypotonia, apnoeic spells, cyanosis, and impaired metabolic responses to cold stress. Symptoms of hypotonia and the neonatal benzodiazepine withdrawal syndrome have been reported to persist from hours to months after birth.Other neonatal withdrawal symptoms include hyperexcitability, tremor and gastrointestinal upset (diarrhea or vomiting). Breast feeding by mothers using midazolam is not recommended.
Neonates
Midazolam is sometimes used in neonatal intensive care unit care. When used, additional caution is required in neonates; midazolam should not be used for longer than 72 hours due to risks of tachyphylaxis, and the possibility of development of a benzodiazepine withdrawal syndrome, as well as neurological complications. Bolus injections should be avoided due to the increased risk of cardiovascular depression, as well as neurological complications.
Children
In 2011, the European Medicines Agency granted a marketing authorisation for a buccal application form of midazolam, sold under the trade name Buccolam. Buccolam was approved for the treatment of prolonged, acute, convulsive seizures in patients from three months to less than 18 years of age. This was the first application of a paediatric-use marketing authorisation (PUMA).
Pharmacokinetics
Midazolam is a short-acting benzodiazepine in adults with an elimination half-life of one to four hours; however, in the elderly, as well as young children and adolescents, the elimination half-life is longer. Midazolam is metabolised into an active metabolite alpha1-hydroxymidazolam. Age related deficits, renal and liver status affect the pharmacokinetic factors of midazolam as well as its active metabolite.
History
Midazolam is among about 35 benzodiazepines which are currently used medically, and was synthesised in 1975 by Walser and Fryer at Hoffmann-LaRoche, Inc in the United States. Owing to its water solubility, it was found to be less likely to cause thrombophlebitis than similar drugs. The anticonvulsant properties of midazolam were studied in the late 1970s, but not until the 1990s did it emerge as an effective treatment for convulsive status epilepticus
This medication is used in children before a procedure or anesthesia to cause drowsiness, decrease anxiety, and cause forgetfulness of the surgery or procedure. It should be used while the child is under the care of a health professional. It is not for home or long-term use.
Midazolam belongs to a class of medications called benzodiazepines, which produce a calming effect on the brain and nerves (central nervous system). It is thought to work by increasing the effect of a certain natural chemical (GABA) in the brain.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used short-term for sleep problems (e.g., trouble sleeping, "night terrors").
How to use midazolam
A healthcare professional will prepare and measure your dose. Take this medication by mouth as directed by your doctor. It is usually given as a single dose before a procedure or anesthesia.
The dosage is based on your medical condition, response to therapy, weight, and other medications you may be taking.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as shaking, sweating, vomiting, abdominal/muscle cramps, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase the dose, take it more frequently, or take it for a longer time than prescribed. Talk with the doctor if this medication stops working well. Properly stop the medication when so directed.
Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless the doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in the bloodstream. Consult the doctor or pharmacist for more details.
Nausea, vomiting, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify the doctor or pharmacist promptly.
Remember that the doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell the doctor immediately if any of these unlikely but serious side effects occur: rapid/slow/shallow breathing, mental/mood changes (e.g., agitation, aggressive behavior), uncontrollable movements (e.g., shaking/tremor), slow/fast heartbeat, vision changes (e.g., blurred vision).
Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, trouble breathing.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.
Before taking midazolam, tell the doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., diazepam); or if you have any other allergies. This product may contain inactive ingredients (such as cherry flavoring), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle).
Before using this medication, tell the doctor or pharmacist your medical history, especially of: kidney disease, liver disease, breathing problems (e.g., chronic obstructive pulmonary disease-COPD, sleep apnea), heart disease (e.g., congestive heart failure), glaucoma (open-angle), personal or family history of regular use/abuse of drugs/alcohol.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell the doctor or dentist that you are using this medication.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Infants born to mothers who used similar medications for an extended time have had withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Consult your doctor for more details.
This medication passes into breast milk. Consult your doctor before breast-feeding.
The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with the doctor or pharmacist first.
This drug should not be used with the following medications because very serious interactions may occur: delavirdine, efavirenz, HIV protease inhibitors (e.g., ritonavir, saquinavir, atazanavir), sodium oxybate.
If you are currently using any of these medications listed above, tell the doctor or pharmacist before starting midazolam.
Before using this medication, tell the doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs affecting liver enzymes that remove midazolam from your body (such as azole antifungals including itraconazole/ketoconazole, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifabutin/rifampin, St. John's wort, certain anti-seizure medicines including carbamazepine/phenytoin, calcium channel blockers including diltiazem/verapamil, certain SSRIs including fluoxetine/fluvoxamine, nefazodone, conivaptan, aprepitant).
Tell the doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenobarbital), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine, morphine), psychiatric medicines (e.g., chlorpromazine, clozapine, amitriptyline, trazodone), a certain herbal product (kava).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask the pharmacist about using those products safely.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately.Symptoms of overdose may include: drowsiness, confusion, loss of coordination.
Notes
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current procedure only. Do not use it later for another condition or procedure unless told to do so by the doctor. A different medication may be necessary in that case.
Laboratory and/or medical tests (e.g., breathing, blood pressure, heartbeat) should be performed periodically to monitor your progress or check for side effects. Consult the doctor for more details.
Missed Dose
Not applicable.
Storage
Not applicable. This medication is given in a hospital, clinic, or doctor's office and will not be stored at home.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
