Dormicum (midazolam; sedative-hypnotic)

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

Uses

What is Dormicum used for?

Dormicum is used to relieve anxiety and cause sleepiness among patients due for surgery. It also causes loss of consciousness and short-term memory before and during surgery. Some uses include the treatment of patients in intensive care units, dental extraction, and other minor and major operations. The drug allows individuals to withstand stress and cooperate during hospital procedures.

How should I take Dormicum?

The duration of treatment should be as short as possible. Generally, the duration of treatment varies from a few days to a maximum of 2 weeks. The tapering-off process should be tailored to the individual. Treatment with Dormicum should not be terminated abruptly.

Dormicum tablets should be taken immediately before going to sleep and swallowed whole with fluid.

Dormicum can be taken at any time of the day, provided the patient is subsequently assured of at least 7 to 8 hours of undisturbed sleep.

How do I store Dormicum?

Dormicum is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Dormicum in the bathroom or the freezer. There may be different brands of midazolam that may have different storage needs. 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. 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 Dormicum?

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 Dormicum?

Common expected side effects include irritability, coughing, hiccups, insomnia, nightmares, drowsiness, headache, nausea, vomiting, restlessness, and speech difficulty.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dormicum)?

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:

• Disulfiram
• Flumazenil
• Isoniazid
• Levodopa
• Probenecid
• Ranitidine
• St. John’s wort
• Caffeine
• Cimetidine

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 Dormicum?

Do not drink alcohol for at least 24 hours after taking midazolam. This medication can increase the effects of alcohol, which could be dangerous.

Grapefruit and grapefruit juice may interact with midazolam and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking midazolam.

What health conditions may interact with Dormicum?

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 for an adult?

Oral, Tablet

• 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 :

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, Tablet

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 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.

Maintenance 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 Dormicum available?

Dormicum is available in the following dosage forms and strengths:

• Tablet 7.5mg
• Tablet 15mg
• Solution for injection (IV/IM) 5mg/mL in 3 mL ampule

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 the nearest emergency room.

What should I do if I miss a dose?

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.