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Zolpidem MR
Zolpidem MR is a Non-benzodiazepine hypnotic (Z-drug) Small molecule drug developed by Astellas Pharma Inc. It is currently FDA-approved for Insomnia (sleep onset and sleep maintenance). Also known as: Stilnox CR, Ambient CR, FK199B.
Zolpidem MR is a sedative-hypnotic that binds to GABA-A receptors in the brain to promote sleep onset and maintenance.
Zolpidem MR is a small molecule that acts as a positive allosteric modulator of the GABA A receptor alpha-1/beta-1/gamma-2. It is used to treat sleep disorders, including sleep initiation and maintenance disorders, primary insomnia, and sleep disorders.
At a glance
| Generic name | Zolpidem MR |
|---|---|
| Also known as | Stilnox CR, Ambient CR, FK199B |
| Sponsor | Astellas Pharma Inc |
| 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 is a non-benzodiazepine hypnotic (Z-drug) that selectively binds to alpha-1 subunit-containing GABA-A receptors, enhancing inhibitory GABAergic neurotransmission. The modified-release (MR) formulation provides biphasic release: an immediate-release component for sleep onset and an extended-release component for sleep maintenance throughout the night.
Approved indications
- Insomnia (sleep onset and sleep maintenance)
Common side effects
- Dizziness
- Headache
- Drowsiness/somnolence
- Nausea
- Complex sleep behaviors
- Amnesia
Key clinical trials
- A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients (PHASE4)
- A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia (PHASE3)
- A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients (PHASE3)
- A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia (PHASE3)
- A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients (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 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 MR CI brief — competitive landscape report
- Zolpidem MR updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about Zolpidem MR
What is Zolpidem MR?
How does Zolpidem MR work?
What is Zolpidem MR used for?
Who makes Zolpidem MR?
Is Zolpidem MR also known as anything else?
What drug class is Zolpidem MR in?
What development phase is Zolpidem MR in?
What are the side effects of Zolpidem MR?
What does Zolpidem MR target?
Related
- Drug class: All Non-benzodiazepine hypnotic (Z-drug) drugs
- Target: All drugs targeting GABA-A receptor (alpha-1 subunit selective)
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Neurology / Sleep Medicine
- Indication: Drugs for Insomnia (sleep onset and sleep maintenance)
- Also known as: Stilnox CR, Ambient CR, FK199B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing