目的 通过挖掘莱博雷生不良反应风险信号，以期促进临床安全合理用药。方法 下载美国食品药品监督管理局不良事件报告系统（FAERS）数据库中莱博雷生2019年1月—2024年12月数据，采用报告比值比（ROR）和比例报告比值比（PRR）2种公式法检测莱博雷生不良事件信号。结果 共检测到以莱博雷生为首要怀疑药物的不良事件信号为1 249次，涉及目标人群为656例。其中女性356例（54.27%）多于男性237例（36.13%），45岁以上患者共计127例（19.36%）。阳性不良事件信号种类主要系统器官分类（SOC）为神经系统疾病、精神病类、全身性疾病及给药部位各种反应等。按阳性信号频数排名靠前的不良反应为药物无效、睡眠性瘫痪、嗜睡等。按阳性信号强度排名靠前的为睡眠性瘫痪、猝倒症、睡惊症等。结论 以上不良反应信号和风险提出了警示作用，为合理使用莱博雷生提供了参考依据。

Objective To mining the risk signal of adverse reaction of lemborexant, to promote the safe and rational clinical drug use. Methods Download lemborexant adverse event in FAERS database from January 2019 to December 2024 to detect lemborexant adverse event signals by using ROR and PRR. Results A total of 1 249 adverse reaction signal events were detected with lemborexant as the primary suspected drug, involving a target population of 656 cases. Among them, there were 356 females (54.27%) and 237 males (36.13%), with 127 patients aged 45 and above (19.36%). Types of positive adverse reaction signals were detected, with the main SOC being nervous system disorders, psychiatric disorders, and general disorders, and administration site conditions. The top adverse reactions ranked by the frequency of positive signals were drug inefficacy, sleep paralysis, lethargy, etc. Sleep paralysis, cataplexy and sleep fright were the top ones according to the positive signal intensity. Conclusion Above adverse reaction signals and risks put forward a warning effect, and provided a reference basis for rational use of lemborexant.

R971