What question did this study set out to answer?

To evaluate the efficacy and safety of daridorexant in treating insomnia disorder in women aged 47-55 during menopausal transition.

January 14, 2026Open Access

Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial.

Key Points

To evaluate the efficacy and safety of daridorexant in treating insomnia disorder in women aged 47-55 during menopausal transition.
Randomized, double-blind, placebo-controlled design
Participants aged 47-55 years with insomnia were assigned to daridorexant 25 mg, 50 mg, or placebo
Treatment lasted for 3 months with daily assessments
Sleep outcomes were measured using polysomnography and questionnaires
Daridorexant 50 mg reduced wake after sleep onset (WASO) and latency to persistent sleep (LPS) significantly compared to placebo
Total sleep time (sTST) increased by an average of 21.8 minutes with daridorexant 50 mg
Improvements were also noted in insomnia-related daytime impairment as measured by the IDSIQ
Low incidence of somnolence and morning sleepiness observed across all groups

Abstract

Objectives To evaluate the efficacy and safety of daridorexant in women aged 47-55 years with insomnia disorder, an age group representative of the menopause transition.Study Design In this randomized, double-blind, placebo-controlled study (NCT03545191), conducted in 10 countries between May 2018 and May 2020, 930 patients with insomnia disorder were randomized using interactive response technology (1:1:1) to receive a single film-coated tablet of daridorexant 25 mg, 50 mg, or placebo every evening for 3 months. Subgroup analyses were performed among the 117 women aged 47-55 (25 mg n = 43; 50 mg n = 35; placebo n = 39).Main Outcome Measures Efficacy endpoints included change from baseline to Month 3 of treatment 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, as recorded on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Safety endpoints included adverse events and score on a visual analog scale for morning sleepiness. Efficacy was analyzed in all randomized subjects, and safety in all who received at least one treatment dose.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 an 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). No marked deviations from the effect in the overall population were observed. The incidence of somnolence/fatigue was low and comparable across groups. Morning sleepiness improved in all groups.Conclusions These analyses suggest that daridorexant 50 mg provides benefit in sleep outcomes and daytime functioning in women aged 47-55 with insomnia disorder. Daridorexant 50 mg is well tolerated in this population, with no increased risk of next-morning sleepiness or somnolence.Gov Identifier NCT03545191.

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