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idorsia Media Release March 10 , 2021 FDA accepts the new drug application for review of Idorsia's daridorexant for the treatment of adult patients with insomnia ● The application includes robust data from the Phase 3 registration program , which demonstrated efficacy of daridorexant on objective and subjective sleep parameters , and an improvement in daytime functioning , while maintaining a favorable safety profile Allschwil , Switzerland - March 10 , 2021 Idorsia Ltd ( SIX : IDIA ) today announced that the US Food and Drug Administration ( FDA ) has accepted the new drug application ( NDA ) for review of Idorsia's investigational dual orexin receptor antagonist , daridorexant , for the treatment of adult patients with insomnia . Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria . Insomnia , a condition of overactive wake signaling , is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning . Dissatisfaction with sleep refers to the difficulty to initiate and / or maintain sleep on at least three nights per week for at least three months , despite adequate opportunity to sleep . Jean - Paul Clozel , MD and Chief Executive Officer of Idorsia commented : " I'm very happy that this first regulatory hurdle is behind us . This was a huge NDA and the team has done an excellent job in preparing the dossier , on which the FDA can judge the properties and merits of daridorexant . We now stand - by to work with the FDA to answer any questions that might arise concerning the effect of daridorexant on sleep , daytime functioning and its safety profile . " The NDA includes data from a comprehensive clinical and non - clinical development program . In the Phase 3 registration program , daridorexant showed statistically significant and clinically meaningful improvements in sleep during the night and , for the first time for an insomnia treatment , in daytime functioning , which were sustained over time . The Phase 3 program provided a deep understanding of the safety and tolerability profile of daridorexant . Adverse reactions reported with a frequency of ≥ 2 % in daridorexant - treated patients and greater ( ≥ 1 % ) than in placebo - treated patients in 3 - month efficacy trials were headache , somnolence , fatigue , dizziness , and nausea . The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo . Patients reported no next - morning sleepiness compared to placebo as assessed by the morning visual analogue scale ( VAS ) . These results make daridorexant the first sleep medication to demonstrate an improvement in sleep and daytime functioning , as measured by a newly developed and validated instrument , while keeping a favorable safety profile in adult and elderly patients .