{"id":"zolpidem-mr","safety":{"commonSideEffects":[{"rate":"5-10%","effect":"Dizziness"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-15%","effect":"Drowsiness/somnolence"},{"rate":"2-5%","effect":"Nausea"},{"rate":"<1%","effect":"Complex sleep behaviors"},{"rate":"1-3%","effect":"Amnesia"}]},"_chembl":{"chemblId":"CHEMBL5483039","moleculeType":null,"molecularWeight":"393.02"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Zolpidem MR is a sedative-hypnotic that binds to GABA-A receptors in the brain to promote sleep onset and maintenance.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:16:40.194Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Insomnia (sleep onset and sleep maintenance)"}]},"trialDetails":[{"nctId":"NCT01181232","phase":"PHASE4","title":"A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2009-10","conditions":"Sleep Initiation and Maintenance Disorders, Primary Insomnia","enrollment":132},{"nctId":"NCT00283946","phase":"PHASE3","title":"A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-02","conditions":"Sleep Initiation and Maintenance Disorders, Sleep Disorders","enrollment":876},{"nctId":"NCT00374777","phase":"PHASE3","title":"A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-08","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":450},{"nctId":"NCT00999219","phase":"PHASE3","title":"A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2006-03","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":55},{"nctId":"NCT00956319","phase":"PHASE4","title":"A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2009-05","conditions":"Sleep Initiation and Maintenance Disorders, Primary Insomnia","enrollment":42},{"nctId":"NCT00630175","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-09","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":113},{"nctId":"NCT00425243","phase":"PHASE3","title":"Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2004-08","conditions":"Sleep Initiation and Maintenance Disorders","enrollment":1025}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Stilnox CR","Ambient CR","FK199B"],"phase":"marketed","status":"active","brandName":"Zolpidem MR","genericName":"Zolpidem MR","companyName":"Astellas Pharma Inc","companyId":"astellas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}