被捧为“神药”的它，说明书要改了！小心抑郁、自杀倾向……

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a revision of the prescribing information for Montelukast formulations to enhance public safety regarding medication use, particularly concerning neuropsychiatric adverse reactions [2][4]. Group 1: Regulatory Changes - The NMPA's announcement includes a unified revision of the prescribing information for Montelukast formulations, which encompasses Montelukast sodium tablets, chewable tablets, granules, and orally dissolving films [2]. - The revised prescribing information will include warnings about neuropsychiatric adverse reactions reported across all age groups, including severe reactions such as depression and suicidal tendencies [4]. Group 2: Clinical Implications - Montelukast, developed by Merck and first approved in 1998, is a selective leukotriene receptor antagonist primarily used for treating asthma and allergic rhinitis [7]. - The drug is commonly used in children due to concerns about the side effects of inhaled corticosteroids, although it may cause side effects such as drowsiness, mental excitement, nightmares, and even depressive tendencies [7]. - Medical professionals are advised to conduct a thorough benefit/risk analysis based on the newly revised prescribing information when selecting medications for patients [9].