Expert consensus and regulatory recommendations on clinical application of daridorexant
CHEN Gui-hai
LI Yi
LI Zhi-yu
PAN Ji-yang
WANG Xu-yi
WANG Yu-ping
ZHANG Xiao-chu
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.
Keywords：insomnia disorderdaridorexantdual orexin receptor antagonistabusehuman abuse potential studycontrolled substance
Publication Date：2024-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 836-843 )