Daridorexant for adults with attention deficit hyperactivity disorder (ADHD) and insomnia disorder: an exploratory study.

The main goal of this naturalistic study was to assess the effect of one month of daridorexant treatment in adults with a primary diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) and comorbid Insomnia Disorder. The working hypothesis was that daridorexant, a dual orexin receptor antagonist with demonstrated efficacy for insomnia, would improve both subjective and objective sleep quality in this clinical population. ADHD and Insomnia Disorder were clinically diagnosed by two experienced psychiatrists and further confirmed using standardized psychometric tools. Participants were evaluated at baseline and after one month of therapy using self-report questionnaires—the Insomnia Severity Index (ISI) and the Sleep Condition Indicator (SCI) —and one-week actigraphy (ActTrust 2®, Condor Instruments Ltda.) during the fourth treatment week. Actigraphy provided objective estimates of Total Sleep Time (TST), Sleep Onset Latency (SOL), Sleep Efficiency (SE), Wake After Sleep Onset (WASO), and midsleep variability (StDev Midsleep). Since several parameters were not normally distributed (SCI, SE, StDev Midsleep, SOL), non-parametric tests (Related-Samples Wilcoxon Signed Rank Test) were applied, with multiple-comparison control via Benjamini–Hochberg’s False Discovery Rate (FDR) correction (q = 0.05). After treatment, ISI and SCI scores indicated significant better perceived sleep quality, while actigraphy showed increased TST and SE as well as reduced SOL, with moderate-to-strong effect sizes. No significant changes emerged for WASO or StDev Midsleep. After FDR correction, improvements in ISI, SCI, and TST remained significant.

Author affiliation: Brain Center Firenze (BCF Research), Florence, Italy

本自然观察研究的核心目标为评估为期1个月的达利雷生（daridorexant）治疗对原发性诊断为注意缺陷多动障碍（Attention-Deficit/Hyperactivity Disorder，ADHD）共病失眠障碍（Insomnia Disorder）的成人患者的疗效。本研究的工作假说为：作为一种已被证实对失眠具有疗效的双重食欲素受体拮抗剂（dual orexin receptor antagonist），达利雷生可改善该临床人群的主、客观睡眠质量。注意缺陷多动障碍与失眠障碍均由两名经验丰富的精神科医师进行临床诊断，并通过标准化心理测量工具进一步验证。研究对象在基线期与1个月治疗结束后接受评估：采用自评问卷——失眠严重指数量表（Insomnia Severity Index，ISI）与睡眠状态指数量表（Sleep Condition Indicator，SCI）——并于第4治疗周开展为期1周的体动记录仪（actigraphy，ActTrust 2®，Condor Instruments Ltda.）监测。体动记录仪可提供以下客观睡眠参数的估算值：总睡眠时间（Total Sleep Time，TST）、入睡潜伏期（Sleep Onset Latency，SOL）、睡眠效率（Sleep Efficiency，SE）、入睡后觉醒时长（Wake After Sleep Onset，WASO）以及睡眠中变异度（StDev Midsleep）。鉴于多项参数（SCI、SE、StDev Midsleep、SOL）不符合正态分布，本研究采用非参数检验——相关样本威尔科克森符号秩检验（Related-Samples Wilcoxon Signed Rank Test）——并通过Benjamini-Hochberg错误发现率（False Discovery Rate，FDR）校正（q=0.05）进行多重比较校正。治疗结束后，ISI与SCI评分显示受试者感知睡眠质量显著改善，体动记录仪监测结果显示TST与SE升高、SOL缩短，且效应量为中等到强水平。WASO与StDev Midsleep未出现显著变化。经FDR校正后，ISI、SCI与TST的改善仍具有统计学显著性。

作者单位：意大利佛罗伦萨脑科学中心（Brain Center Firenze，BCF Research）