For research and educational purposes only. Not medical advice.
Zolpidem Reference
Educational, not medical advice reference for Zolpidem: Sleep; regulatory status, evidence posture, source review, and schedule notes. Also known as Ambien,…
Reference summary
Perlis 2004 J Clin Psychiatry studied long-term non-nightly zolpidem dosing in adults with primary insomnia. The label-level efficacy is well-established for short-term sleep-onset and sleep-maintenance use. The FDA reduced recommended doses for women in 2013 due to next-morning impairment data (5 mg immediate-release, 6.25 mg extended-release for women; men can use the original 10 mg / 12.5 mg).
Regulatory and posture
- Categories
- Sleep
- Aliases
- Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist, Non-benzodiazepine GABA-A agonist (small molecule, not a peptide)
- Evidence posture
- human - Complex sleep behaviors (sleep-walking, sleep-driving, sleep-eating with no memory) carry a label-level Boxed Warning since 2019. Next-morning impairment is dose-dependent and well documented.
- Regulatory status
- FDA-approved as Ambien (1992) for short-term treatment of insomnia, with subsequent approvals for extended-release (Ambien CR, 2005), sublingual (Edluar, 2009), low-dose middle-of-the-night sublingual (Intermezzo, 2011), and oral spray (Zolpimist) formulations. Schedule IV controlled substance.
- Content review status
- label verified