目的 基于美国美国食品药品管理局不良事件报告系统（FAERS）数据库对新型双重食欲素受体拮抗剂（达利雷生、苏沃雷生、莱博雷生）的不良信号进行挖掘。方法 采用报告比值比（ROR）法与比例报告比值（PRR）法，筛选FAERS数据库2014年第1季度—2025年第3季度中，以达利雷生、苏沃雷生、莱博雷生为首要怀疑药物的不良反应报告。结果 共识别1 113种不良反应，主要集中于神经系统、精神病类、胃肠系统等，其中40种不良反应未被药品说明书收录，部分严重反应需高度警惕。结论 建议临床医生用药前全面评估患者病史，尤其精神疾病、神经系统疾病史，遵循低剂量起始原则，密切随访患者症状；同时告知患者治疗初期避免驾驶等高危活动，为个体化用药提供指导，保障用药安全。

Objective To explore the adverse signals of the new dual orexin receptor antagonists (daridorexant, suvorexant, lemborexant) based on the FAERS database. Methods The ROR method and PRR method were used to screen the adverse reaction reports in the FAERS database from the first quarter of 2014 to the third quarter of 2025, which daridorexant, suvorexant, lemborexant were the primary suspected drugs. Results A total of 1 113 adverse reactions were identified, mainly concentrated in the nervous system, mental disorders, and gastrointestinal system, among which 40 adverse reactions were not included in the drug instructions, and some serious reactions require high vigilance. Conclusion It is recommended that clinicians comprehensively assess the patient’s medical history before prescribing the drugs, especially the history of mental disorders and neurological diseases. Follow the principle of starting with a low dose, closely monitor the patient’s symptoms. At the same time, inform the patient to avoid high-risk activities such as driving during the initial treatment period, providing guidance for individualized medication and ensuring medication safety.

R971