{"id":"ft218","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Enuresis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FT218 uses Avadel's proprietary Micropump technology to deliver sodium oxybate in a sustained-release manner, allowing for once-nightly dosing instead of the multiple daily doses required by immediate-release sodium oxybate. Sodium oxybate is a central nervous system depressant that enhances slow-wave sleep and reduces cataplexy and excessive daytime sleepiness in narcolepsy patients.","oneSentence":"FT218 is a long-acting formulation of sodium oxybate that provides extended-release delivery to treat narcolepsy and other sleep-wake disorders.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:32.250Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Narcolepsy type 1 with cataplexy"},{"name":"Narcolepsy type 2"}]},"trialDetails":[{"nctId":"NCT06525077","phase":"PHASE3","title":"Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Avadel","startDate":"2024-08-01","conditions":"Idiopathic Hypersomnia","enrollment":150},{"nctId":"NCT04451668","phase":"PHASE3","title":"An Open Label Study of FT218 in Subjects With Narcolepsy","status":"COMPLETED","sponsor":"Avadel","startDate":"2020-06-12","conditions":"Narcolepsy, Cataplexy, Excessive Daytime Somnolence","enrollment":184},{"nctId":"NCT02720744","phase":"PHASE3","title":"Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy","status":"COMPLETED","sponsor":"Avadel","startDate":"2016-11-17","conditions":"Excessive Daytime Sleepiness, Cataplexy, Narcolepsy","enrollment":212}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":19,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["LUMRYZ"],"phase":"phase_3","status":"active","brandName":"FT218","genericName":"FT218","companyName":"Avadel","companyId":"avadel","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FT218 is a long-acting formulation of sodium oxybate that provides extended-release delivery to treat narcolepsy and other sleep-wake disorders. Used for Narcolepsy type 1 with cataplexy, Narcolepsy type 2.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}