达利雷生临床应用专家共识及监管建议
Expert consensus and regulatory recommendations on clinical application of daridorexant
陈贵海 1李毅 1李志裕 1潘集阳 1王绪轶 1王玉平 1张效初1
作者信息
- 1. 达利雷生临床应用专家共识及监管建议专家写作组
- 折叠
摘要
失眠障碍对患者及社会造成了沉重的负担,国内亟须疗效及安全性俱佳、滥用风险低、可及性理想、可长期使用、有效改善日间功能的非管制类创新机制催眠药.作为美国FDA及欧洲EMA批准上市的双重食欲素受体拮抗剂(dual orexin receptor antagonist,DORA),达利雷生(daridorexant)针对失眠患者展现出良好的疗效及安全性,可改善日间功能,且无明确的耐药性、依赖性及滥用证据,其公共卫生风险显著低于被列入《精神药品品种目录》的苯二氮(卓)类药物和γ-氨基丁酸(γ-aminobutyric acid,GABA)能"Z类药物".综合多方面证据,针对达利雷生的药监管理力度宜与该药可能产生的临床及公共卫生效益相权衡,以更好地满足人民群众的失眠治疗需求.
Abstract
Insomnia disorder imposes a heavy burden on patients and society,and there is an urgent need in China for non-controlled innovative hypnotic drugs with good efficacy and safety,low risk of abuse,ideal accessibility,long-term use,and effective improvement of daytime function.As a dual orexin receptor antagonist(DORA)approved by the US FDA and the EMA,daridorexant has demonstrated good efficacy and safety for insomnia patients,improved daytime function,and no clear evidence of tolerance,dependence,and abuse.Its public health risk is significantly lower than that of benzodiazepines and gamma-aminobutyric acid(GABA)"Z-drugs"listed in the"Catalogue of Psychotropic Drugs".Considering various pieces of evidence,the drug regulatory intensity for daridorexant should be balanced with the potential clinical and public health benefits it may bring,in order to better meet the insomnia treatment needs of the people.
关键词
失眠障碍/达利雷生/双重食欲素受体拮抗剂/滥用/人类滥用潜力研究/管制物质Key words
insomnia disorder/daridorexant/dual orexin receptor antagonist/abuse/human abuse potential study/controlled substance引用本文复制引用
出版年
2024
NETL
NSTL
万方数据