{"id":"cep-10953-armodafinil","safety":{"commonSideEffects":[{"rate":"~20%","effect":"Headache"},{"rate":"~10%","effect":"Nausea"},{"rate":"~5%","effect":"Insomnia"},{"rate":"~5%","effect":"Anxiety"},{"rate":"~5%","effect":"Dizziness"},{"rate":"~5%","effect":"Dry mouth"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Armodafinil is the active R-enantiomer of modafinil, a wakefulness-promoting agent. It binds to and inhibits the dopamine transporter, increasing dopamine concentration in the nucleus accumbens and prefrontal cortex. The drug may also modulate other neurotransmitter systems including norepinephrine and histamine, contributing to its stimulant-like effects without the typical sympathomimetic profile of classical stimulants.","oneSentence":"Armodafinil promotes wakefulness by increasing dopamine levels in the brain, likely through dopamine reuptake inhibition and other monoaminergic pathways.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:05:20.101Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Narcolepsy"},{"name":"Obstructive sleep apnea"},{"name":"Shift work sleep disorder"},{"name":"Excessive daytime sleepiness"}]},"trialDetails":[{"nctId":"NCT00983437","phase":"PHASE3","title":"Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury","status":"TERMINATED","sponsor":"Cephalon, Inc.","startDate":"2009-08-31","conditions":"Traumatic Brain Injury","enrollment":49},{"nctId":"NCT01624480","phase":"PHASE1","title":"Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2012-07","conditions":"Narcolepsy","enrollment":40},{"nctId":"NCT01121536","phase":"PHASE3","title":"Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder","status":"TERMINATED","sponsor":"Cephalon","startDate":"2010-04-30","conditions":"Depression","enrollment":867},{"nctId":"NCT01305408","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder","status":"COMPLETED","sponsor":"Cephalon","startDate":"2011-03","conditions":"Depression","enrollment":399},{"nctId":"NCT01072630","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder","status":"COMPLETED","sponsor":"Cephalon","startDate":"2010-03","conditions":"Depression","enrollment":492},{"nctId":"NCT01072929","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder","status":"COMPLETED","sponsor":"Cephalon","startDate":"2010-01","conditions":"Depression","enrollment":433},{"nctId":"NCT00228553","phase":"PHASE3","title":"Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness","status":"COMPLETED","sponsor":"Cephalon","startDate":"2004-05","conditions":"Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome","enrollment":743},{"nctId":"NCT00079677","phase":"PHASE3","title":"Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome","status":"COMPLETED","sponsor":"Cephalon","startDate":"2004-03","conditions":"Obstructive Sleep Apnea, Sleep Hypopnea","enrollment":263},{"nctId":"NCT00080288","phase":"PHASE3","title":"Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD","status":"COMPLETED","sponsor":"Cephalon","startDate":"2004-03","conditions":"Excessive Sleepiness, Shift Work Sleep Disorder","enrollment":254},{"nctId":"NCT00078325","phase":"PHASE3","title":"Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)","status":"COMPLETED","sponsor":"Cephalon","startDate":"2004-02","conditions":"Obstructive Sleep Apnea, Hypopnea","enrollment":395},{"nctId":"NCT00078312","phase":"PHASE3","title":"Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder","status":"COMPLETED","sponsor":"Cephalon","startDate":"2004-01","conditions":"Narcolepsy, Sleep Apnea, Obstructive, Sleep Apnea Syndromes","enrollment":328},{"nctId":"NCT00078377","phase":"PHASE3","title":"Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy","status":"COMPLETED","sponsor":"Cephalon","startDate":"2004-03","conditions":"Narcolepsy","enrollment":196},{"nctId":"NCT00772005","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia","status":"COMPLETED","sponsor":"Cephalon","startDate":"2008-09","conditions":"Schizophrenia","enrollment":287},{"nctId":"NCT01080807","phase":"PHASE4","title":"Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder","status":"COMPLETED","sponsor":"Cephalon","startDate":"2010-03","conditions":"Excessive Sleepiness","enrollment":385}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"CEP-10953 (Armodafinil)","genericName":"CEP-10953 (Armodafinil)","companyName":"Cephalon","companyId":"cephalon","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Armodafinil promotes wakefulness by increasing dopamine levels in the brain, likely through dopamine reuptake inhibition and other monoaminergic pathways. Used for Narcolepsy, Obstructive sleep apnea, Shift work sleep disorder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}