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zolpidem

N05CF02

Forms & Strengths

Tablet: 5 mg, 10 mg
Tablet, Extended Release: 6.25 mg, 12.5 mg
Sublingual Tablet (Edluar): 5 mg, 10 mg
Oral Spray (Intermezzo): 1.75 mg, 3.5 mg

Adult Dosing

Immediate release: 5 to 10 mg orally once daily immediately before bedtime
Extended release: 6.25 to 12.5 mg orally once daily immediately before bedtime
Sublingual: 5 to 10 mg sublingually once daily immediately before bedtime
Low-dose (women/elderly/hepatic impairment): 5 mg IR, 6.25 mg ER, or 1.75-3.5 mg SL/Spray

Pediatric Dosing

Safety and efficacy not established in pediatric patients < 18 years of age

Indications

Short-term treatment of insomnia characterized by difficulties with sleep initiation
Intermezzo: Treatment of middle-of-the-night awakening with difficulty returning to sleep

Mechanism of Action

Non-benzodiazepine hypnotic agent (Z-drug)
Acts as an agonist at the benzodiazepine receptor complex (omega-1 subtype)
Selectively modulates the GABA-A receptor channel macromolecular complex, increasing chloride conductance and causing neuronal inhibition

Contraindications

Known hypersensitivity to zolpidem
History of complex sleep behaviors after taking zolpidem
Severe hepatic impairment

Adverse Reactions

Somnolence, dizziness, headache
Drowsiness the next morning, fatigue
Complex sleep behaviors (e.g., sleep-walking, sleep-driving, preparing/eating food while asleep)
Amnesia, hallucinations, depression, agitation
Anaphylaxis and angioedema

Drug Interactions

Central nervous system (CNS) depressants (e.g., opioids, alcohol, tricyclic antidepressants): Enhanced CNS depression and psychomotor impairment
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): Increased zolpidem exposure and risk of adverse effects
Strong CYP3A4 inducers (e.g., rifampin, St. John's wort): Significantly decreased zolpidem plasma concentrations and efficacy

Curated Content: Needs Vetting Before Put to Clinical Use