Last reviewed · How we verify
Zolpidem (SL800750)
Zolpidem is a sedative-hypnotic that selectively binds to benzodiazepine receptors on GABA-A channels in the central nervous system to promote sleep onset.
Zolpidem is a sedative-hypnotic that selectively binds to benzodiazepine receptors on GABA-A channels in the central nervous system to promote sleep onset. Used for Insomnia (sleep onset and maintenance), Short-term treatment of insomnia in adults.
At a glance
| Generic name | Zolpidem (SL800750) |
|---|---|
| Sponsor | Sanofi |
| Drug class | Non-benzodiazepine hypnotic (Z-drug) |
| Target | GABA-A receptor (alpha-1 subunit selective) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | FDA-approved |
Mechanism of action
Zolpidem acts as a positive allosteric modulator of GABA-A receptors, enhancing the inhibitory effects of gamma-aminobutyric acid (GABA) and increasing chloride ion influx into neurons. This hyperpolarizes neuronal membranes and reduces neuronal excitability, leading to sedation and sleep induction. It has selective affinity for the alpha-1 subunit of GABA-A receptors, which contributes to its hypnotic properties with relatively less muscle relaxation or anticonvulsant activity compared to non-selective benzodiazepines.
Approved indications
- Insomnia (sleep onset and maintenance)
- Short-term treatment of insomnia in adults
Common side effects
- Dizziness
- Drowsiness/somnolence
- Headache
- Amnesia/memory impairment
- Complex sleep behaviors
- Dependence/tolerance
Key clinical trials
- Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA (PHASE4)
- Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia (PHASE3)
- Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia (PHASE3)
- Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zolpidem (SL800750) CI brief — competitive landscape report
- Zolpidem (SL800750) updates RSS · CI watch RSS
- Sanofi portfolio CI