3053 Efficacy and safety of daridorexant in patients with chronic insomnia disorder and comorbid nocturia

Abstract Introduction Chronic insomnia and nocturia are frequently associated, particularly in older adults impacting sleep quality, daytime functioning and quality of life. This study evaluated the efficacy and safety of daridorexant in patients with insomnia and comorbid nocturia. Methods This double-blind, placebo-controlled, two-way cross-over study randomised 60 patients aged ≥55 years with chronic insomnia and self-reported nocturia to 4-weeks nightly treatment of daridorexant 50 mg or placebo. This was followed by a 14–21-day washout period, after which patients received the alternate 4-week treatment. The primary endpoint was change from baseline to Week 4 in self-reported total sleep time (sTST). Other insomnia endpoints included change from baseline in ISI score, sTST, depth of sleep and daytime functioning (Insomnia Daytime symptoms and Impacts Questionnaire [IDSIQ] total score. Nocturia endpoints, evaluated using the Minze diary Pod, included change from baseline in number and time to first nocturnal void. Safety endpoints included adverse events (AEs) and AEs of special interest (AESI: falls, urinary incontinence). Results Daridorexant (vs. placebo) significantly increased mean sTST (56.6 vs. 35.7 mins; p = 0.002) at Week 4; significant improvements were seen from Week 1. Daridorexant (vs. placebo) significantly (p < 0.05) decreased ISI scores (Weeks 2, 4) and significantly (p < 0.05) improved depth of sleep (Weeks 1–4) and IDSIQ total score (Weeks 1, 3). Daridorexant (vs. placebo) reduced the number of nocturnal voids (Week 1: −1.5 vs. -1.0, p < 0.001; Week 4: −1.6 vs. -1.3, p = 0.09) and increased median time to first nocturnal void (difference to placebo, Week 1: +31 mins, p = 0.0027; Week 4: +23 mins, p = 0.2026). No serious AEs//AEs leading to discontinuation were reported in the study. No AESIs were reported during daridorexant administration. Conclusion In patients with insomnia and comorbid nocturia, daridorexant improves sleep, daytime functioning and nocturia symptoms, with no increased risk of falls or urinary incontinence. Funding: Idorsia Pharmaceuticals Ltd