{"id":"auris-sedina","safety":{"commonSideEffects":[{"rate":"10-30%","effect":"Drowsiness"},{"rate":"5-15%","effect":"Dizziness"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-10%","effect":"Nausea"},{"rate":"null","effect":"Memory impairment"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"It works by enhancing the effects of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain, leading to a calming effect and inducing sleep. This is achieved through its action on the GABA_A receptor, a ligand-gated chloride channel that plays a crucial role in regulating neuronal excitability.","oneSentence":"Auris-Sedina is a sedative-hypnotic agent used to treat insomnia.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:02:56.389Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Insomnia"}]},"trialDetails":[{"nctId":"NCT00967317","phase":"PHASE3","title":"Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.","status":"UNKNOWN","sponsor":"Laboratorios Osorio de Moraes Ltda.","startDate":"2009-12","conditions":"Otitis, Efficacy, Tolerability","enrollment":188}],"_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":[],"phase":"phase_3","status":"active","brandName":"Auris-Sedina","genericName":"Auris-Sedina","companyName":"Laboratorios Osorio de Moraes Ltda.","companyId":"laboratorios-osorio-de-moraes-ltda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Auris-Sedina is a sedative-hypnotic agent used to treat insomnia. Used for Insomnia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}