Krystal Andrew, Blier Pierre, Culpepper Larry, Nierenberg Andrew A, Takaesu Yoshikazu, Kubota Naoki, Moline Margaret, Malhotra Manoj, Pinner Kate, Yardley Jane
University of California, San Francisco, California, USA.
The Royal Institute of Mental Health Research, Ottawa, Ontario, Canada.
Neuropsychopharmacol Rep. 2025 Mar;45(1):e12509. doi: 10.1002/npr2.12509. Epub 2024 Dec 4.
Individuals with insomnia frequently have comorbid depression or anxiety. This study sought to provide a preliminary indication of the effects of lemborexant (LEM) in subjects treated for mild depression/anxiety symptoms.
E2006-G000-303 (NCT02952820; EudraCT 2015-001463-39; SUNRISE-2) was a 12-month, phase 3, randomized, placebo-controlled, double-blind study where subjects with insomnia disorder were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10) for 6 months. During the second 6 months (not reported), placebo-treated subjects were re-randomized to LEM5 or LEM10. In this post hoc analysis, changes from baseline (CFB) in subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Fatigue Severity Scale, and Insomnia Severity Index were evaluated in subjects treated with medications for symptoms of depression/anxiety (subpopulation).
Of 949 randomized subjects, 61 treated with medications for symptoms of depression/anxiety were included. In the subpopulation, CFB comparing LEM with placebo were generally smaller than the overall population due to a larger placebo response in the subpopulation. However, the magnitudes of CFB within the active treatment groups for sSOL, sWASO, sTST, and sSE were similar between the subpopulation and the overall population. No new safety signals were observed in the subpopulation.
LEM treatment benefited subjects with insomnia treated with medications for depression/anxiety symptoms, with no new safety signals. A greater placebo response in the subpopulation than in the overall population decreased the drug versus placebo effect size for LEM, as has been reported for other insomnia medications.
失眠患者常伴有抑郁症或焦虑症。本研究旨在初步表明lemborexant（LEM）对治疗轻度抑郁/焦虑症状患者的效果。
E2006-G000-303（NCT02952820；EudraCT 2015-001463-39；SUNRISE-2）是一项为期12个月的3期随机、安慰剂对照、双盲研究，失眠症患者被随机（1:1:1）分为安慰剂组、5毫克LEM（LEM5）组或10毫克LEM（LEM10）组，治疗6个月。在第二个6个月期间（未报告），接受安慰剂治疗的受试者被重新随机分为LEM5组或LEM10组。在这项事后分析中，评估了接受抑郁症/焦虑症症状药物治疗的受试者（亚组）中，受试者报告的（主观）入睡潜伏期（sSOL）、睡眠效率（sSE）、睡眠中觉醒时间（sWASO）、总睡眠时间（sTST）、疲劳严重程度量表和失眠严重程度指数相对于基线的变化（CFB）。
在949名随机分组的受试者中，61名接受抑郁症/焦虑症症状药物治疗的受试者被纳入。在该亚组中，由于亚组中安慰剂反应较大，LEM与安慰剂相比的CFB通常小于总体人群。然而，活性治疗组内sSOL、sWASO、sTST和sSE的CFB幅度在亚组和总体人群之间相似。在该亚组中未观察到新的安全信号。
LEM治疗使接受抑郁症/焦虑症症状药物治疗的失眠患者受益，且未出现新的安全信号。如其他失眠药物所报道的那样，亚组中的安慰剂反应大于总体人群，这降低了LEM与安慰剂的效应大小。
