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Midazolam (sedative-hypnotic, sleep aid)

Uses|Precautions & warnings|Side effects|Interactions|Dosage

Midazolam is the generic name of a benzodiazepine which has sedative-hypnotic properties. In the Philippines, midazolam is a dangerous drug assigned to schedule IV. This means only physicians with a S-2 license can prescribe this drug.

midazolam

Uses

What is midazolam used for?

Midazolam is a short-acting benzodiazepine that acts as a central nervous system (CNS) depressant. Depending on the dose, midazolam is used to treat insomnia and anxiety, induce sedation prior to minor surgical and dental procedures, and inducing anesthesia.

How should I take midazolam?

Midazolam is usually available as an oral tablet or an IM/IV injection. The oral tablets should be swallowed whole without crushing or chewing. It is preferably taken on an empty stomach for optimal absorption and effect. You can take it 1-2 hours before a meal or 2-3 hours after a meal.

The IM/IV injection is typically prepared and administered by a licensed healthcare worker in the hospital or clinic. Do not self-administer IM/IV injections.

How do I store midazolam?

This product is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store it in the bathroom or the freezer.

There may be different brands of this drug that may have different storage needs. So, it is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush this product down the toilet or pour them into a drain unless instructed to do so. Additionally, it is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using midazolam?

Consult with your doctor or pharmacist, if you are/have:

  • Pregnant or breastfeeding.
  • Taking any other medicines. This includes both prescription and over-the-counter (OTC) medications, such as herbal remedies and dietary supplements.
  • Any other types of allergies, such as to foods, dyes, preservatives, or animals.
  • Any other illnesses, disorders, or medical conditions, such as liver problems or kidney problems.

You should not take this medicine if you are/have:

  • Narrow-angle glaucoma.
  • Allergic to midazolam or to other benzodiazepines.

Is it safe during pregnancy or breastfeeding?

There is positive evidence that shows there is an increased risk of congenital malformations associated with the use of benzodiazepines. Midazolam is excreted in breastmilk and should be used with caution in breastfeeding mothers.

Please always consult with your doctor to weigh the potential benefits and risks before taking this medication. This medication is pregnancy risk category D, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur from midazolam?

Like all drugs, this product may have side effects. If they occur, side effects are generally mild and resolve once treatment is finished or the dose is lowered. Some reported side effects include:

  • Irritability
  • Coughing, hiccups
  • Worsening of insomnia
  • Nightmares
  • Excessive drowsiness
  • Headache
  • Nausea, vomiting
  • Restlessness
  • Difficulty speaking

Uncommon side effects include mental confusion, hypotension, coma, dizziness, impaired balance, reflexes and coordination, seizures, skin rash, and palpitations. These should be reported immediately to a doctor.

However, not everyone experiences these side effects. In addition, some people may experience other side effects. So, if you have any concerns about a side effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with midazolam?

This medication may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects.

To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist.

Drugs with known interactions:

  • CNS depressants (e.g. alcohol, benzodiazepines, antihistamines)
  • CYP3A4 inhibitors (decrease metabolism and may cause toxicity due to slower clearance):
    • Clarithromycin
    • Erythromycin
    • Diltiazem
    • Itraconazole
    • Ketoconazole
    • Ritonavir
    • Verapamil
    • Goldenseal
    • Grapefruit juice
  • CYP3A4 inducers (increase metabolism and may result in subpar effects due to lower concentration of the drug):
    • Phenobarbital
    • Phenytoin
    • Rifampicin
    • St. John’s Wort
    • Glucocorticoids

If you experience an adverse drug interaction, stop taking this drug and continue taking your other medication. Inform your doctor immediately to reevaluate your treatment plan. Approaches include dose adjustment, drug substitution, or ending therapy.

Does food or alcohol interact with midazolam?

Midazolam may be less absorbed when taken together with food. It is best to take this medication on an empty stomach for maximum absorption and effect. Avoid drinking grapefruit juice while taking this medication as it has a known interaction.

Do not take this drug with alcohol as it may increase the CNS depressive effects which include symptoms ranging from drowsiness to coma to death.

Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with midazolam?

This drug may interact with underlying conditions. This interaction may worsen your health condition or alter the way the drug works. Therefore, it is important to always let your doctor and pharmacist know all the health conditions you currently have, especially:

  • Acute alcohol intoxication
  • Open-angle glaucoma
  • Asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems
  • Kidney or liver disease
  • Congestive heart failure
  • Conditions or chronic pain that require opioid treatment
  • Seizures

Dosage

The information provided is not a substitute for any medical advice. Therefore, you should always consult with your doctor or pharmacist before using any medication.

What is the dose of midazolam for an adult?

Oral

  • For short-term management of insomnia: 7.5 to 15 mg, ideally at bedtime.
  • The dose may need adjustment for elderly patients.

IV/IM injection

  • For sedation for dental and minor surgical procedures:

Initial dose: 2-2.5 mg at a rate of 2 mg/min 5-10 min before procedure, with increments of 0.5-1 mg at intervals of at least 2 min. Total dose: 2.5-7.5 mg.

  • For sedation in critical care:

Loading dose: 0.03-0.3 mg/kg, may be given in increments of 1-2.5 mg at 2 min between each dose.

Maintenance: 0.02-0.2 mg/kg/hr. Patients w/ hypothermia, hypovolaemia or vasoconstriction: Reduce or omit loading dose, and reduce maintenance dose.

  • For anesthesia:

Total dose: 150-250 mcg/kg in premedicated patients and 300-350 mcg/kg for those without premedication. Sedation in combined anaesth: 30-100 mcg/kg by inj or 30-100 mcg/kg/hr by infusion.

  • Premedication in surgery (IM/IV):

70-100 mcg/kg 20-60 min before surgery by deep IM injection or 1-2 mg, 5-30 min before surgery by IV injection, repeat dose if necessary.

What is the dose for a child?

Oral

  • Preoperative sedation:

Ages 6 months to 16 years old: 0.25-1 mg/kg, as a single dose 20-30 minutes before the procedure. Maximum dose of midazolam is 20 mg.

  • Treatment of seizures:

Ages 3-12 months: 2.5 mg; 1-5 years: 5 mg; 5-10 years: 7.5 mg; 10-18 years: 10 mg. Doses are to be given as a single dose.

IV/IM injection

  • Preoperative sedation (IM):

Age 1-15 years: 50-150 mcg/kg. Maximum dose of 10 mg.

*Note: IM route should not be used routinely.

  • Premedication in surgery (IM):

Age 1-15 years: 80-200 mcg/kg given 15-30 mins before surgery by deep IM injection.

  • Sedation for dental and surgical procedures (IV):

Age 6 months to 5 years: 500-100 mcg/kg, maximum dose of 6 mg.

Age 6-12 years: 25-50 mcg/kg, maximum dose of 10 mg.

Initial doses are given over 2-3 minutes with an additional interval of 2-5 minutes.

  • Sedation in critical care (IV):

Age 0-32 weeks: 60 mcg/kg/hr via continuous IV infusion, reduce the dose after 24 hours to 30 mcg/kg/hr. The maximum duration of treatment is 4 days.

Age 32 weeks to 6 months: 60 mcg/kg/hr. The maximum duration of treatment is 4 days for neonates.

Age 6 months to 12 years:

Loading dose: 50-200 mcg/kg given via slow injection over 3 minutes or more.

Maintenence dose: 30-120 mcg/kg/hr given as continuous infusion.

  • Induction of anesthesia (IV):

Age over 7 years: 150 mcg/kg by slow injection.

How is midazolam available?

Midazolam is available in the following brands, dosage forms, and strengths:

  • Midazolam (generic) solution for injection 5 mg/mL (500 mg/100 mL)
  • Dormicum tablets 7.5 mg, 15 mg
  • Dormicum solution for injection 5 mg/mL in 3 mL ampule
  • Dormid solution for injection 1 mg/ mL, 5 mg/mL
  • Dormizol solution for injection 5 mg/mL in 1 mL, 3 mL ampules
  • Midazolex solution for injection 1 mg/ mL, 5 mg/mL
  • Sedoz solution for injection 1 mg/mL in 5 mL vial

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room. You may be given flumazenil as an antidote.

Symptoms of overdose may include:

  • Drowsiness
  • Ataxia (impaired coordination)
  • Dysarthria (muscle weakness and difficulty speaking)
  • Nystagmus (movement or deviation of gaze)

Life-threatening symptoms of overdose include:

  • Apnea (pause in breathing)
  • Hypotension
  • Cardiorespiratory depression (slow heart rate and breathing rate)
  • Loss or weakened reflexes
  • Coma

What should I do if I miss a dose?

In most cases, your dose will be administered by a licensed health professional so missing a dose will be unlikely. In case a dose was missed, do not administer double the dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Midazolam https://www.mims.com/philippines/drug/info/midazolam Accessed June 16, 2021

Midazolam – Injection, USP https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208878Orig1s000lbl.pdf Accessed June 16, 2021

Midazolam (Injection Route) https://www.mayoclinic.org/drugs-supplements/midazolam-injection-route/description/drg-20064813 Accessed June 16, 2021

RA 9165 – Comprehensive Dangerous Drugs Act of 2002 https://www.officialgazette.gov.ph/2002/06/07/republic-act-no-9165 Accessed June 16, 2021

Midazolam. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Accessed June 16, 2021. http://online.lexi.com

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Written by Stephanie Nicole Nera, RPh, PharmD Updated Jun 16
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