Expected to provide new hope for over 200 million people with insomnia: Xiansheng Pharmaceutical's new generation of innovative anti insomnia drugs have been approved in clinical trials for sleep | drugs | Xiansheng
On July 20th, the new anti insomnia drug Daridorexant hydrochloride tablets, jointly developed by Xiansheng Pharmaceutical and Idorsia, Switzerland, have been approved for clinical trials by the National Medical Products Administration. They are intended for the treatment of adult insomnia patients whose symptoms persist for at least 3 months and have an impact on daytime function. Overseas clinical studies have shown that this drug can significantly improve sleep onset and maintenance in people with insomnia, prolong sleep time, support safe long-term medication, and is expected to bring better treatment to a large number of chronic insomnia patients in China.
Daridorexant is a dual orexin receptor antagonist, which is different from traditional insomnia drugs that promote sleep by calming the brain. It blocks the activation of orexin receptors, reduces arousal drive, promotes sleep, and maintains sleep status without changing the patient's sleep structure. No residual effects of the next day were observed.
The subjects who received 50 milligrams of Daridorexant treatment showed a significant decrease in sleep latency by 34.8 minutes in the third month of treatment, a significant decrease in wakefulness time by 29.4 minutes after falling asleep, and a significant increase in self-reported total sleep time by 57.7 minutes. Based on this calculation, patients taking this medication are equivalent to gaining nearly an entire night's sleep per week.
According to the National Health Commission's guidelines for the diagnosis and treatment of mental disorders, the prevalence of insomnia in the Chinese population ranges from 10% to 20%, which means that out of 1.3 billion people, 200 to 300 million suffer from insomnia, but the medical treatment rate is less than 30%. Many people with insomnia mainly rely on medication control to alleviate their condition. At present, the anti insomnia drugs approved for marketing in China are mainly divided into two categories: benzodiazepines represented by alprazolam, estazolam, diazepam, and clonazepam, as well as non benzodiazepines represented by zolpidem and dexzopiclone. But the former is prone to damaging the sleep structure, with significant residual effects the next day, and patients usually feel tired after waking up; The latter's sleep maintenance effect is not ideal, and after medication, it will still wake up repeatedly or early at night. There is a huge space between demand and reality.
The Idorsia research team found that the causes of human insomnia are closely related to appetite hormones. Antagonism of the appetite hormone system can help insomnia patients maintain a natural sleep structure, leading to the development of the dual orexin receptor antagonist Daridorexant. It reduces overactive central arousal by blocking the binding of the awakening neuropeptide, orexin, to its receptors. Because its unique mechanism can reduce arousal drive, induce sleep occurrence, do not change sleep structure, and has no residual effects the next day, it is expected to become a disruptive iteration of traditional insomnia drugs.
The phase III clinical data of Daridorexant has been published in The Lancet Neurology. Compared to placebo, a 50 milligram dose of Daridorexant significantly improved the patient's sleep onset time, sleep maintenance time, and self-reported total sleep time at the first and third months. In addition, no symptoms such as drug dependence, rebound insomnia, abuse, or withdrawal reactions were observed in clinical studies.
In addition, studies have shown that this drug can not only improve nighttime sleep in adults and elderly individuals with chronic insomnia, but also improve daytime function in patients. It is currently the only DORA class insomnia drug approved by the European Medicines Agency to improve daytime function. At present, the drug has obtained clinical data for up to 12 months of continuous treatment, and research results support its safe long-term use.
On November 15, 2022, Xiansheng Pharmaceutical entered into an exclusive licensing agreement with Idorsia, granting Daridorexant exclusive rights for domestic development and commercialization. At present, the drug has been approved for marketing in the United States, United Kingdom, Italy, Germany, Switzerland, and Canada. There is currently no such dual orexin receptor antagonist type insomnia medication on the market in China.