Lederer Katharina, Benes Heike, Fine Alan, Shoffner Sylvia, Bacchelli Sandro, Diaz David Castro, Batista Jose Emilio, Rowles Racheal, Marco Tobias Di, Meinel Michael
Advanced Sleep Research GmbH, Berlin, Germany.
Somni Bene, Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany.
J Sleep Res. 2025 Mar 13:e70002. doi: 10.1111/jsr.70002.
This double-blind, placebo-controlled, two-way crossover trial evaluated the efficacy and safety of daridorexant in patients with chronic insomnia and comorbid nocturia. In total, 60 patients aged ≥55 years with insomnia complaints for ≥3 months, Insomnia Severity Index (ISI) ≥13 and ≥3 voids/night for ≥1 month were randomised (1:1) to daridorexant 50 mg/placebo for 4 weeks followed by crossover after a 14-21-day washout period. The primary endpoint was change from baseline to Week (W) 4 in self-reported total sleep time (sTST). Other endpoints included change in ISI score, sleep depth and quality (visual analogue scale scores), nocturnal voids (mean number, time to first) and daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire score [IDSIQ]). At W4, daridorexant significantly increased sTST versus placebo (least-squares mean difference [LSMD] 20.9 min, 95% confidence interval [CI] 8.0-33.7; p = 0.002); significant improvements were also seen at W1-3. Compared with placebo, daridorexant significantly decreased (p < 0.001) ISI at both timepoints, W2 (LSMD -3.7, 95% CI -5.1 to -2.3) and W4 (LSMD -3.3, 95% CI -4.7 to -1.8) and significantly improved (p < 0.05) sleep depth (W1, 2, 3, 4), sleep quality (W1, 2, 3) and IDSIQ total score (W1, 3). Daridorexant versus placebo reduced the number of voids (LSMD [95% CI]: W1-0.6 [-0.9 to -0.3], p < 0.001; W4-0.3 [-0.7 to +0.1], p = 0.090) and increased median time to first void (difference to placebo, W1: +31 min, p = 0.0027; W4: +23 min, p = 0.2026). No adverse events of special interest (falls/urinary incontinence) were reported during daridorexant treatment. In conclusion, in patients with chronic insomnia and nocturia, daridorexant improves both conditions with a favourable safety profile.
这项双盲、安慰剂对照、双向交叉试验评估了达立多雷克斯对慢性失眠合并夜尿症患者的疗效和安全性。总共60名年龄≥55岁、有失眠主诉≥3个月、失眠严重程度指数（ISI）≥13且每晚排尿≥3次持续≥1个月的患者被随机（1:1）分为接受50毫克达立多雷克斯/安慰剂治疗4周，在14 - 21天的洗脱期后进行交叉治疗。主要终点是自我报告的总睡眠时间（sTST）从基线到第4周（W4）的变化。其他终点包括ISI评分的变化、睡眠深度和质量（视觉模拟量表评分）、夜间排尿次数（平均次数、首次排尿时间）以及日间功能（失眠日间症状和影响问卷评分[IDSIQ]）。在W4时，与安慰剂相比，达立多雷克斯显著增加了sTST（最小二乘均值差异[LSMD]为20.9分钟，95%置信区间[CI]为8.0 - 33.7；p = 0.002）；在W1 - 3时也观察到了显著改善。与安慰剂相比，达立多雷克斯在两个时间点（W2和W4）均显著降低了ISI（p < 0.001），W2时LSMD为 - 3.7，95% CI为 - 5.1至 - 2.3；W4时LSMD为 - 3.3，95% CI为 - 4.7至 - 1.8，并且显著改善了睡眠深度（W1、2、3、4）、睡眠质量（W1、2、3）和IDSIQ总分（W1、3）（p < 0.05）。达立多雷克斯与安慰剂相比减少了排尿次数（LSMD[95% CI]：W1为 - 0.6[-0.9至 - 0.3]，p < 0.001；W4为 - 0.3[-0.7至 + 0.1]，p = 0.090），并增加了首次排尿的中位时间（与安慰剂的差异，W1：+31分钟，p = 0.0027；W4：+23分钟，p = 0.2026）。在达立多雷克斯治疗期间未报告特别关注的不良事件（跌倒/尿失禁）。总之，对于慢性失眠和夜尿症患者，达立多雷克斯可改善这两种情况，且安全性良好。
