In recent years, sleep health issues have received increasing market attention. Public data shows that in 2021, the market size of anti insomnia drugs in China has reached the level of billions of yuan, and it is expected to reach 21.19 billion yuan by 2030. In this context, anti insomnia drugs with both medical and consumer properties have gradually become another "golden track" for pharmaceutical companies to increase their layout after GLP-1 weight-loss drugs.
It is reported that since 2026, there has been a round of intensive achievements in the field of insomnia drugs in China. From approval for market launch to clinical promotion, from innovative chemical drugs to Class 1.1 new Chinese medicine drugs, multiple technological routes are advancing in parallel.
On July 27th, the innovative anti insomnia drug Fazan Lei Sheng tablets began its online debut. This is the first domestically developed dual orexin receptor antagonist (DORA) that can be used to treat adult insomnia patients characterized by difficulty falling asleep or maintaining sleep. This drug is the second Class 1 innovative drug launched by Yangtze River Pharmaceutical Group this year and was approved for insomnia in May of this year.
On June 20th, the National Medical Products Administration officially approved the launch of the global new generation of innovative anti insomnia drug, Dalirasen (trade name: Kewei Ke), jointly developed by Xiansheng Pharmaceutical and Swiss company Idorsia, in China. This medication is suitable for treating adult insomnia patients characterized by difficulty falling asleep and/or maintaining sleep. Dali Leisheng, as an innovative dual orexin receptor antagonist, works by precisely blocking the binding of orexin neuropeptides (including orexin A and B) to their receptors, effectively reducing abnormally elevated orexin levels and naturally inducing sleep.
On June 8th, Tianshi Li announced that the company has received the "Drug Registration Certificate" for the innovative Chinese medicine category 1.1, Zao Ren Ning Xin Dripping Pills. This medicine is used to improve insomnia caused by traditional Chinese medicine syndrome differentiation of liver and blood deficiency, with occasional sleep and wakefulness, accompanied by dizziness or vertigo, dry eyes, etc. This product is developed based on the experience of Chinese medical masters, with outstanding clinical value, and has successfully entered the high-quality insomnia treatment track with a scale of over 15 billion yuan. The announcement mentioned that the company's cumulative R&D investment in this project is 98.78 million yuan.
In June, Jiqun Pharmaceutical independently developed a short-term insomnia specific drug, Ganuosi, after 11 years of research and development ® Succinic acid docetamine tablets have been officially approved for market by the National Medical Products Administration. Clinical data shows that Janos ® It can effectively shorten the time to fall asleep, prolong the overall sleep duration, and reduce the number of nighttime awakenings, with a lasting effect of 8-12 hours.
In May, Kanghong Pharmaceutical launched a randomized, double-blind, placebo-controlled, dose escalation phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of KHN707 tablets in health trial participants. KHN707 tablets are chemical drugs, with indications for insomnia. The main purpose of this experiment is to evaluate the safety and tolerability of a single oral dose of KHN707 tablets for health trial participants; The secondary objectives are to evaluate pharmacokinetic characteristics, explore the impact on QTc interval, and assess the effect of bedtime administration on pharmacokinetics.
Overall, in 2026, there will be intensive progress in the field of insomnia drugs in China, indicating that domestic pharmaceutical companies are shifting from "following imitation" to "precise regulation and awakening" in differentiated competition. In the future, whoever can meet the needs of patients in this field in a safer, more convenient, and more in line with their daily needs, is expected to gain more competitive advantages in this billion dollar market