目的 对国内已上市的2种双重食欲素受体拮抗剂（DORAs）——莱博雷生片与盐酸达利雷生片进行临床综合评价，旨在为医疗机构的新药遴选、目录优化及临床合理用药提供科学依据。方法 系统收集整理参评药物公开资料，依据《中国医疗机构药品评价与遴选快速指南（第二版）》建立的评价体系，从药学特性、有效性、安全性、经济性、其他属性5个维度进行百分制量化评价。结果 综合评价总分从高到低依次为：莱博雷生片（82.4分）和盐酸达利雷生片（79.8分），二者均达到“强推荐”级别。莱博雷生片在有效性（尤其改善入睡潜伏期与夜间清醒时间）、药学特性、经济性及其他属性方面更具优势；盐酸达利雷生片则在安全性方面表现更佳，重度不良反应风险相对较低。结论 莱博雷生片与盐酸达利雷生片均为治疗成人失眠的优选药物，建议医疗机构根据具体的临床需求（如侧重疗效或关注安全性）进行差异化遴选。鉴于DORAs类药物上市时间较短，其评价工作需动态开展，持续纳入新的循证证据与经济信息，以确保评价结果的时效性与准确性。

Objective To clinically assess two domestically marketed dual orexin receptor antagonists(DORAs), Lemborexant Tablets and Daridorexant Hydrochloride Tablets, to provide a scientific basis for drug selection, formulary optimization, and rational clinical use in healthcare institutions. Methods Publicly available data on the evaluated drugs were systematically collected and organized. Based on the evaluation framework established in the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition), a 100-point quantitative assessment was conducted across five dimensions: pharmaceutical properties, efficacy, safety, economy, and other attributes. Results The overall comprehensive evaluation scores, in descending order, were as follows: Lemborexant Tablets(82.4 points) and Daridorexant Hydrochloride Tablets(79.8 points). Both drugs achieved a “strong recommendation” rating. Lemborexant showed advantages in efficacy(particularly in reducing sleep onset latency and wake after sleep onset), pharmaceutical properties, economy, and other attributes. Daridorexant, however, performed better in safety, with a relatively lower risk of severe adverse reactions. Conclusion Both Lemborexant Tablets and Daridorexant Hydrochloride Tablets are recommended as preferred treatments for adult insomnia. Healthcare institutions are advised to make differentiated selections based on specific clinical requirements(e.g., prioritizing efficacy or emphasizing safety). Given the relatively recent market entry of DORAs, their evaluation should be updated dynamically, incorporating new evidence-based data and economic information to ensure the timeliness and accuracy of the assessment results.

R971

国家自然科学基金青年基金资助项目(32201171)