Zolpidem

Non-benzodiazepine hypnotic, Sleep aid, Schedule IV controlled substance

Zolpidem (tartrate)

Ambien (IR), Ambien CR (biphasic-release), Edluar (sublingual), Intermezzo (low-dose sublingual for middle-of-night awakening), Zolpimist (oral spray)

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Summary

Classes

Non-benzodiazepine hypnotic, Sleep aid, Schedule IV controlled substance

Pharmacy

Starting dose

5 mg PO at bedtime for women, 5-10 mg for men (per FDA's 2013 sex-specific dose reduction for women due to slower clearance). Ambien CR 6.25 mg women / 6.25-12.5 mg men. Intermezzo SL 1.75 mg women / 3.5 mg men

Preparations

IR tablets 5, 10 mg; CR tablets 6.25, 12.5 mg; SL tablets 1.75, 3.5, 5, 10 mg; oral spray

US FDA Max

10 mg/day (IR); 12.5 mg/day (CR)

Pharmacology

Routes

Oral, sublingual, oromucosal spray

Onset

15-30 minutes

Duration

6-8 hours (IR); 8 hours (CR via biphasic release)

Half-life

~2.5 hours

Bioavailability

~70% (oral)

Pregnancy

Limited human data; case reports of neonatal sedation with late-pregnancy exposure.^{[citation needed]}

Legal status

Schedule IV controlled substance in US. Carries the FDA Boxed Warning for complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating, other parasomnias) added in 2019

Purported mechanism

Selective positive allosteric modulator of the GABA-A receptor preferentially at α1-containing subtypes (the "sedation" subtypes), providing more sedation per unit anxiolysis and muscle relaxation than the non-selective benzodiazepines. The short half-life is the basis of less next-morning grogginess in most patients.▲0▼ The 2013 FDA dose reduction for women reflects slower clearance in women and higher rates of next-morning impaired driving; the 2019 Boxed Warning for complex sleep behaviors followed accumulated case reports. CYP3A4 substrate, so CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) substantially raise plasma exposure.