0350 Daridorexant in patients with insomnia disorder: number needed to treat, number needed to harm & likelihood to be helped or harmed

Abstract Introduction Patients with insomnia disorder have difficulty initiating or maintaining sleep and impaired daytime functioning. Daridorexant is a dual orexin receptor antagonist approved for the treatment of insomnia. This analysis reports number needed to treat (NNT), harm (NNH), likelihood be helped harmed (LHH) daridorexant 25 mg 50 versus placebo over 3 months. Methods Phase data from one two pivotal trials (N=930: randomized 1:1:1 mg, placebo) were used calculate NNT, NNH, LHH. For NNT analysis, wakefulness after onset, latency persistent sleep, self-reported total time, Insomnia Daytime Symptoms Impacts Questionnaire, Severity Index explored. was assessed using range clinically meaningful thresholds (CMTs), minimal clinical improvement (MiCI) marked improvement. NNH performed on adverse events (AEs) occurring in >1% participants any arm. LHH values calculated all outcomes estimates somnolence fatigue AEs. Results At Month 1 3, at MiCI ranged 5–9 6–12, respectively, statistically significantly different placebo, indicating good therapeutic response. had least < 10 CMTs across outcomes. NNTs between 7–328 8–1666. negative not confirming tolerability profile. AE, 83.3–200 placebo. 4.3–10.2. Conclusion both positive benefit-risk ratio compared Furthermore, showed ‘good’ (i.e. 10) efficacy endpoints relation CMTs. results confirmed profile doses. Support (if any) Funded by Idorsia Pharmaceutical Ltd.