在失眠障碍中Seltorexant的有效性和安全性:一项随机临床试验
Sofie Mesens1, Andrew D Krystal2, Rama Melkote3
1Johnson & Johnson, Beerse, Belgium.
JAMA psychiatry
|August 13, 2025
概括
塞尔托雷克桑 (Seltorexant) 是一种新型的素-2受体对抗剂,有效地改善了成年失眠患者的睡眠启动和维持. 剂量为10毫克和20毫克,在14天内表现出持续的疗效,耐受性良好.
科学领域:
- 药理学 药理学是指药理学的学科.
- 睡眠医学 睡眠医学
- 临床试验 临床试验
背景情况:
- 现有的失眠治疗方法有局限性.
- 素受体对抗剂代表了治疗睡眠障碍的新疗法.
- 塞尔托雷克桑 (Seltorexant) 向素-2受体,调节睡眠和清醒状态.
研究的目的:
- 为了确定最佳的剂量范围,安全性和耐受性seltorexant在成年人失眠障碍.
- 为了评估seltorexant在改善睡眠参数中的有效性,使用了多睡眠学.
主要方法:
- 一个随机的,双盲的,安慰剂和活性控制的,剂量确定研究.
- 参与者每天晚上接受口服塞尔托雷克桑 (5,10或20毫克),安慰剂或佐尔皮,持续14天.
- 多睡眠学测量了持续睡眠的延迟 (LPS) 和睡眠开始后的觉醒 (WASO-6).
主要成果:
- 与安慰剂和皮相比,10 mg和20 mg的塞尔托雷克桑特显著改善了1晚的LPS和WASO-6.
- 对于seltorexant而言,LPS和WASO-6的改善在第13天持续,与皮不同.
- 与安慰剂 (49.3%) 和皮 (42.5%) 相比,与治疗相关的不良事件在塞尔托雷克桑特 (33.8%) 较低.
结论:
- 塞尔托雷克桑10毫克和20毫克有效改善失眠患者的睡眠开始和维持.
- 该药物在14天的治疗中显示出良好的安全性和耐受性.
- 塞尔托雷克桑特是一种有前途的新药理学选择,用于治疗失眠障碍.
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