Expert consensus and regulatory recommendations on clinical application of daridorexant
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.
NETL
NSTL
万方数据
