{"id":"suvorexant-high-dose-hd","safety":{"commonSideEffects":[{"rate":null,"effect":"Somnolence / next-day drowsiness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Abnormal dreams / nightmares"},{"rate":null,"effect":"Sleep paralysis"}]},"_chembl":{"chemblId":"CHEMBL1083659","moleculeType":"Small molecule","molecularWeight":"450.93"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Suvorexant selectively antagonizes orexin receptors OX1R and OX2R, which are neuropeptide receptors involved in maintaining wakefulness. By blocking these receptors, the drug reduces the activity of wake-promoting neurons, thereby facilitating sleep initiation and consolidation. The high-dose formulation is being evaluated to assess efficacy and safety at elevated exposure levels.","oneSentence":"Suvorexant is an orexin receptor antagonist that blocks wake-promoting signals in the brain to promote sleep onset and maintenance.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:36:54.238Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Insomnia (sleep onset and/or sleep maintenance)"}]},"trialDetails":[{"nctId":"NCT01097629","phase":"PHASE3","title":"Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-05-03","conditions":"Primary Insomnia","enrollment":1020},{"nctId":"NCT01097616","phase":"PHASE3","title":"Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-05-05","conditions":"Primary Insomnia","enrollment":1023}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["MK-4305"],"phase":"phase_3","status":"active","brandName":"Suvorexant High Dose (HD)","genericName":"Suvorexant High Dose (HD)","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Suvorexant is an orexin receptor antagonist that blocks wake-promoting signals in the brain to promote sleep onset and maintenance. Used for Insomnia (sleep onset and/or sleep maintenance).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}