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The hypnotics Daridorexant hydrochloride tablets obtained the clinical trial approval issued by the national medical products administration

Release time:2023-07-21

On July 20, 2023, Daridorexant hydrochloride tablets obtained the clinical trial approval issued, which aimed at the treatment of adult insomnia patients with symptoms persisting for at least 3 months and affecting daytime function. Overseas clinical studies have shown that Daridorexant can significantly improve the sleep time of insomniacs and support safe long-term medication of the drug, which is expected to bring better treatments to the large number of chronic insomnia patients in China.


Insomnia is a disease that causes a wide range of disturbances, and clinical symptoms are often characterized by difficulty in falling asleep and/or difficulty in maintaining sleep. A recent meta-analysis of the prevalence of insomnia in the Chinese general population showed that the prevalence of insomnia in China is about 15%,[i] with hundreds of millions of people suffering from insomnia. There is a strong demand from insomnia sufferers for innovative medicines that can improve the quality of sleep and daytime function.


Daridorexant is a dual orexin receptor antagonist (“DORA”), which blocks the binding of the wake-promoting orexin neuropeptides (orexin A and orexin B) with its receptors. Rather than assisting sleep through broad inhibition of brain activity, Daridorexant only antagonizes the activation of orexin receptors by the orexin neuropeptides and consequently, Daridorexant decreases the wake drive, allowing sleep to occur without altering the sleep architecture.


Daridorexant’s Overseas Products ——QUVIVO’s Diagram

Phase 3 data has been reported in The Lancet Neurology: the pivotal studies demonstrated that Daridorexant significantly improved sleep onset, sleep maintenance, and self-reported total sleep time at the first and third month of treatment compared to placebo without altering the sleep architecture.


In addition, the studies also showed that Daridorexant is safe and well-tolerated with no evidence of dependency, rebound insomnia, withdrawal symptoms or drug abuse, which is different from those reported with benzodiazepine receptor agonists. Clinical data on Daridorexant are available for up to 12 months of continuous treatment, which can support the long-term medication of Daridorexant.


In addition to improving the nighttime sleep of adults with chronic insomnia disorder, Daridorexant also has a positive impact on the daytime functioning of the patients and is also the only DORA approved by the European Medicines Agency (EMA) that have an impact on daytime functioning.


Currently, Daridorexant has been approved in the United States, Great Britain, Italy, Germany, Switzerland and Canada. On November 15, 2022, the Group entered into an exclusive license agreement with Idorsia, and was granted an exclusive right to develop and commercialize Daridorexant in the Greater China region.



Headquartered near Basel, Switzerland — a European biotech-hub — Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet — the ideal constellation to translate R&D efforts into business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,300 highly qualified specialists dedicated to realizing their ambitious targets. 

[i] Cao, X. L., Wang, S. B., Zhong, B. L., Zhang, L., Ungvari, G. S., Ng, C. H., Li, L., Chiu, H. F., Lok, G. K., Lu, J. P., Jia, F. J., & Xiang, Y. T. (2017). The prevalence of insomnia in the general population in China: A meta-analysis. PloS one, 12(2), e0170772.https://doi.org/10.1371/journal.pone.0170772.