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Zolpidem (Myslee®)
Zolpidem is a selective benzodiazepine receptor agonist that enhances inhibitory GABA signaling in the central nervous system to promote sleep onset.
Zolpidem is a selective benzodiazepine receptor agonist that enhances inhibitory GABA signaling in the central nervous system to promote sleep onset. Used for Insomnia (sleep onset and maintenance).
At a glance
| Generic name | Zolpidem (Myslee®) |
|---|---|
| Also known as | Myslee, FK199B |
| Sponsor | Astellas Pharma Inc |
| Drug class | Selective benzodiazepine receptor agonist (non-benzodiazepine hypnotic) |
| Target | GABA-A receptor (alpha-1 subunit selective) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | FDA-approved |
Mechanism of action
Zolpidem binds preferentially to the alpha-1 subunit of GABA-A receptors in the brain, potentiating the effect of the inhibitory neurotransmitter GABA. This increases chloride ion influx into neurons, hyperpolarizing the cell membrane and reducing neuronal excitability. The result is sedation and facilitation of sleep initiation with minimal muscle relaxation or anticonvulsant effects compared to non-selective benzodiazepines.
Approved indications
- Insomnia (sleep onset and maintenance)
Common side effects
- Dizziness
- Drowsiness/somnolence
- Headache
- Amnesia
- Complex sleep behaviors
- Dependence/tolerance
Key clinical trials
- Zolpidem Postmarketing Study in Adolescent Patients With Insomnia (PHASE4)
- A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia (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 (Myslee®) CI brief — competitive landscape report
- Zolpidem (Myslee®) updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI