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Midazolam

Oral
Intravenous
Intramuscular
Intranasal
Class
Hypnotics and sedatives
Subclass
Benzodiazepines
Generic name
Midazolam hydrochloride
Brand names
Nayzilam®
Indications for use
Labeled indications
Adults
•
Facilitation of procedural sedation
Safety risks
Boxed warnings
Drug misuse, drug abuse, benzodiazepine use disorder
•
Use extreme caution in all patients, especially in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness.
Profound sedation, respiratory depression, coma
•
Use extreme caution in patients receiving opioids.
Respiratory depression, airway obstruction
•
Use extreme caution in patients with severe pulmonary disease or conditions associated with respiratory insufficiency such as sleep apnea, cyanotic congenital heart disease, pulmonary hypertension, pneumonia, status asthmaticus, or severe COPD.
Contraindications
Hypersensitivity to midazolam or any of its components or other benzodiazepines
Acute angle-closure glaucoma
Warnings and precautions
Benzodiazepine withdrawal syndrome
•
Do not discontinue abruptly in patients taking the drug for a prolonged period.
Convulsion, somnolence
•
Use caution in patients taking other CNS depressants or using alcohol.
Drug overdose
•
Use caution in individuals with a history of alcholism or substance abuse.
Hypotension, respiratory depression, cardiac arrest
•
Use caution in patients with hemodynamic instability.
Manic episode
•
Use caution in patients with a history of autism, bipolar disorder, or psychosis.
Neonatal abstinence syndrome
•
Use caution in pregnancy.
Seizures
•
Use caution in patients with a history of a seizure disorder.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Suicidal ideation
•
Use caution in patients with severe depression.
Specific populations
Renal impairment
eGFR 20-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Titrate to response. Monitor for signs of respiratory depression and hypotension.
eGFR 10-20 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Titrate to response. Monitor for signs of respiratory depression and hypotension.
eGFR < 10 mL/min/1.73 m²
•
Use with caution. Titrate to response. Monitor for signs of respiratory depression and hypotension.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required. Monitor for respiratory depression and hypotension.
Intermittent hemodialysis
•
Use with caution. Dose as in eGFR < 10 mL/min/1.73 m². Titrate to response. Monitor for respiratory depression and hypotension.
Peritoneal dialysis
•
Use with caution. Dose as in eGFR < 10 mL/min/1.73 m². Titrate to response. Monitor for respiratory depression and hypotension.
Hepatic impairment
Any severity
•
No guidance available. Titrate slowly. Monitor serum concentrations. Monitor for toxicity. - Dosage should be individualized.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Avoid use. Evidence of fetal harm in humans. US FDA pregnancy category D.
•
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
•
Neonates exposed to this drug in the last weeks of pregnancy or in high doses during labor and delivery should be monitored for irregularities in fetal HR, hypotonia, poor sucking, hypothermia, and moderate respiratory depression.
•
If used during pregnancy, monitor the newborn for acute withdrawal syndrome symptoms during the postnatal period.
Breastfeeding
Acceptable for use during breastfeeding.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Apnea, hypertensive crisis, nasal irritation
Common 1-10%
•
Agitation, nystagmus, renal failure, change in taste, cough, dysarthria, fever, headache, headache, hiccups, nasal discharge, nausea, somnolence, throat irritation, vomiting
Uncommon < 1%
•
Bronchospasm, laryngospasm, muscular rigidity, premature ventricular complexes, anxiety, blurred vision, diplopia, dyspnea, hypersalivation, shivering
Unknown frequency
•
Cardiac arrest, cognitive impairment, ↓ cardiac output, ↓ intraocular pressure, ↓ serum cortisol, drug withdrawal syndrome, EEG abnormalities, hives, hypotension, ↑ body temperature, involuntary movements, psychosis, abnormal behavior, depression, seizure, skin rash, suicidal ideation, respiratory arrest, respiratory depression, sedation, thrombophlebitis
Interactions
Drug(s)
Check Interactions
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