Zolpidem
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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
Common uses
Insomnia, sleep-onset type (FDA, short-term)0, Insomnia, sleep-maintenance type (Ambien CR; FDA)0, Middle-of-night awakening with ≥4 hours sleep remaining (Intermezzo SL; FDA)0
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[1]
Bioavailability
~70% (oral)[1]
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[1]
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[1].
References
- ↑ 1.0 1.1 1.2 1.3 FDA Prescribing Information, Ambien (zolpidem tartrate), Sanofi, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s041lbl.pdf