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评估苏沃雷生和右佐匹克隆作为苯二氮䓬类药物治疗伴发抑郁症患者失眠的替代药物。

Assessment of Suvorexant and Eszopiclone as Alternatives to Benzodiazepines for Treating Insomnia in Patients With Major Depressive Disorder.

机构信息

Departments of Clinical Pharmacology and Therapeutics.

Psychiatry, Kyoto University Hospital, Kyoto, Japan.

出版信息

Clin Neuropharmacol. 2022;45(3):52-60. doi: 10.1097/WNF.0000000000000499. Epub 2022 Apr 14.

Abstract

OBJECTIVES

We investigated the utility of switching from benzodiazepines to suvorexant or eszopiclone to manage benzodiazepine-unresponsive insomnia in patients with major depressive disorder (MDD) in a randomized, open-label study.

METHODS

Patients with MDD who have insomnia symptoms (a score of >7 on the Insomnia Severity Index Japanese version [ISI-J]), who had received benzodiazepine treatment for more than 2 weeks (n = 18) were randomized to 4 weeks of suvorexant (20 or 15 mg/d) or eszopiclone (3 or 2 mg/d) treatment. The primary endpoint was an improvement in insomnia severity from baseline assessed by the ISI-J score at 2 and 4 weeks after switching from benzodiazepines. The secondary endpoints included changes in the scores of the Pittsburgh Sleep Quality Index Japanese version, the Beck Depression Inventory II, Generalized Anxiety Disorder 7, the digit span test, and the digit symbol substitution test from baseline. Adverse events were recorded throughout the study.

RESULTS

Patients taking suvorexant or eszopiclone had improved ISI-J scores (-4.3 for suvorexant and -4.1 for eszopiclone at week 4; P = 0.04 for eszopiclone). Both drugs tended to improve the Beck Depression Inventory II and Generalized Anxiety Disorder 7 scores 2 and 4 weeks after switching. The Pittsburgh Sleep Quality Index Japanese version, digit symbol substitution test, and digit span test scores and the incidence of adverse events did not change from baseline.

CONCLUSIONS

Switching to suvorexant or eszopiclone was well tolerated and improved the severity of benzodiazepine-unresponsive insomnia in MDD patients. Both drugs could be beneficial alternatives to benzodiazepines for treating insomnia in MDD patients.

摘要

目的

我们在一项随机、开放标签研究中调查了将苯二氮䓬类药物转换为苏沃雷生或右佐匹克隆来治疗伴有重度抑郁症(MDD)的患者对苯二氮䓬类药物无反应性失眠的效果。

方法

患有失眠症状(日本版失眠严重度指数[ISI-J]评分>7)且接受苯二氮䓬类药物治疗超过 2 周的 MDD 患者(n=18)被随机分为 4 周的苏沃雷生(20 或 15 mg/d)或右佐匹克隆(3 或 2 mg/d)治疗。主要终点是从基线开始,在转换为苯二氮䓬类药物后 2 和 4 周时,通过 ISI-J 评分评估失眠严重程度的改善。次要终点包括从基线开始,日本版匹兹堡睡眠质量指数、贝克抑郁量表 II、广泛性焦虑症 7 项、数字跨度测试和数字符号替代测试评分的变化。在整个研究过程中记录不良反应事件。

结果

服用苏沃雷生或右佐匹克隆的患者 ISI-J 评分得到改善(苏沃雷生组第 4 周时下降 4.3,右佐匹克隆组下降 4.1;右佐匹克隆组 P=0.04)。两种药物在转换后 2 和 4 周时均趋于改善贝克抑郁量表 II 和广泛性焦虑症 7 评分。日本版匹兹堡睡眠质量指数、数字符号替代测试和数字跨度测试评分以及不良反应事件的发生率与基线相比没有变化。

结论

转换为苏沃雷生或右佐匹克隆的治疗方法耐受良好,并改善了 MDD 患者对苯二氮䓬类药物无反应性失眠的严重程度。两种药物均可能是治疗 MDD 患者失眠的苯二氮䓬类药物的替代药物。

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