{"id":"ramelteon-and-zolpidem","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Complex sleep behaviors"}]},"_chembl":{"chemblId":"CHEMBL1218","moleculeType":"Small molecule","molecularWeight":"259.35"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ramelteon selectively binds to melatonin MT1 and MT2 receptors to regulate circadian rhythm and promote sleep onset, while zolpidem acts as a selective GABA-A receptor modulator to enhance sleep maintenance. The combination leverages complementary mechanisms to address both sleep initiation and consolidation in patients with insomnia.","oneSentence":"This is a fixed-dose combination of ramelteon (a melatonin receptor agonist) and zolpidem (a non-benzodiazepine hypnotic) that promotes sleep through dual mechanisms targeting different sleep-wake pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:03:41.282Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Insomnia characterized by difficulty with sleep onset and/or sleep maintenance"}]},"trialDetails":[{"nctId":"NCT00539110","phase":"PHASE2","title":"Differential Effects of Zolpidem Versus Ramelteon in Burned Children","status":"COMPLETED","sponsor":"Shriners Hospitals for Children","startDate":"2009-12","conditions":"Sleep, Burns","enrollment":10},{"nctId":"NCT00893269","phase":"PHASE1","title":"The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2008-10","conditions":"Marijuana Dependence","enrollment":36},{"nctId":"NCT00568789","phase":"PHASE4","title":"Safety of Ramelteon in Elderly Subjects","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-06","conditions":"Insomnia","enrollment":33},{"nctId":"NCT00492232","phase":"PHASE4","title":"Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia","status":"COMPLETED","sponsor":"Takeda","startDate":"2007-04","conditions":"Chronic Insomnia","enrollment":135}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":74,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Rozerem™","TAK-375","Ambien®"],"phase":"marketed","status":"active","brandName":"Ramelteon and zolpidem","genericName":"Ramelteon and zolpidem","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a fixed-dose combination of ramelteon (a melatonin receptor agonist) and zolpidem (a non-benzodiazepine hypnotic) that promotes sleep through dual mechanisms targeting different sleep-wake pathways. Used for Insomnia characterized by difficulty with sleep onset and/or sleep maintenance.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}