基于临床试验评价新型双重食欲素受体拮抗剂类抗失眠药物daridorexant的有效性及安全性

Evaluation of Efficacy and Safety of a Novel Anti-Insomnia Drug Daridorexant,a New Dual Orexin Receptor Antagonist,Based on Clinical Trials

双重食欲素受体拮抗剂(DORAs)是一类新型抗失眠药物,可通过抑制过度的促觉醒信号、抵消失眠患者的脑过度活跃状态,帮助患者改善失眠症状。Daridorexant是一种新型DORAs,已在多国获批用于治疗成人失眠,其较好地弥补了传统镇静催眠药物及类似机制抗失眠药物未满足的临床需求,如降低了跌倒、次日残留效应等不良反应的发生,且在日间功能恢复、老年群体用药及长期应用依从性等方面具有优越性。本文基于已完成的Ⅰ~Ⅲ期临床研究,对daridorexant的有效性和安全性进行综述,以期为进一步研发和临床应用提供参考依据。

Dual orexin receptor antagonists(DORAs)are a novel class of anti-insomnia drugs that suppress excessive arousal signals,counteract excessive brain activity in insomnia patients,and help alleviate insomnia symptoms.Daridorexant,a new type of DORAs,has been approved for the treatment of adult insomnia in multiple countries.Daridorexant significantly addresses the unmet clinical needs of traditional antiinsomnia drugs and their similar mechanisms,such as reducing the occurrence of adverse reactions such as falls and residual effects the next day;it also offers advantages in terms of daytime functional recovery,elderly population,and long-term application compliance.This article reviews the effectiveness and safety of daridorexant based on completed Phase I~III clinical studies,providing references for its further development and clinical application.