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Introduction Insomnia is common, burdensome, and under-researched in women undergoing the menopausal transition. This is the first evaluation of the efficacy and safety of daridorexant (a novel insomnia treatment), specifically in an age group representative of the menopausal transition, enrolled in the phase 3 study NCT03545191.Methods In this randomized, double-blind study, 930 patients with insomnia disorder received daridorexant 25 mg, 50 mg or placebo for 3 months. Subgroup analyses were performed among the 117 women aged 47-55 years (25 mg n=43; 50 mg n=35; placebo n=39). Efficacy endpoints included change from baseline in polysomnography-measured wake after sleep onset (WASO) and latency to persistent sleep (LPS), self-reported total sleep time (sTST) and insomnia-related daytime impairment (Insomnia Daytime Symptoms and Impacts Questionnaire [IDSIQ]).Results At Month 3, daridorexant 50 mg vs placebo decreased WASO and LPS by a least-squares mean (LSM) of 13.8 min (95% CI -29.0, 1.4) and 14.7 min (-30.0, 0.6) respectively, increased sTST by a LSM of 21.8 min (-3.9, 47.4) and decreased (improved) IDSIQ total score by an LSM of -4.1 (-14.4, 6.3) ( figure 1). These results were generally consistent with those of the overall study population. The incidence of somnolence/fatigue was low in both daridorexant groups and comparable to placebo. Comparable improvements in morning sleepiness (visual analogue scale score) were observed across groups.Conclusions These post-hoc exploratory analyses suggest that daridorexant 50 mg improves sleep outcomes and daytime functioning and is well tolerated in women aged 47-55 years with insomnia disorder.Disclosures Funded by Idorsia Pharmaceuticals Ltd.Abstract O12 Figure 1Change from baseline to Month 3 in efficacy endpoints