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Placebo and zolpidem
Zolpidem is a sedative-hypnotic that binds to GABA-A receptors in the brain to promote sleep onset and maintenance.
Zolpidem is a sedative-hypnotic that binds to GABA-A receptors in the brain to promote sleep onset and maintenance. Used for Insomnia (sleep initiation and maintenance).
At a glance
| Generic name | Placebo and zolpidem |
|---|---|
| Also known as | Ambien® |
| Sponsor | Takeda |
| Drug class | Sedative-hypnotic (non-benzodiazepine) |
| Target | GABA-A receptor (alpha-1 subunit selective) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | FDA-approved |
Mechanism of action
Zolpidem selectively binds to alpha-1 subunit-containing GABA-A receptors, enhancing the inhibitory effects of gamma-aminobutyric acid (GABA) and depressing central nervous system activity. This results in sedation and hypnotic effects that facilitate sleep initiation. The placebo component in this formulation serves as a control or comparative reference in clinical evaluation.
Approved indications
- Insomnia (sleep initiation and maintenance)
Common side effects
- Dizziness
- Drowsiness/somnolence
- Headache
- Complex sleep behaviors
- Amnesia
- Dependence/tolerance
Key clinical trials
- Trial of Zolpidem for Sleep in Children With Autism (PHASE2)
- Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment (PHASE4)
- Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder (PHASE2)
- Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP) (PHASE4)
- Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia (PHASE4)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder (PHASE2)
- A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem (PHASE1)
- A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study (EARLY_PHASE1)
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:
- Placebo and zolpidem CI brief — competitive landscape report
- Placebo and zolpidem updates RSS · CI watch RSS
- Takeda portfolio CI