In recent years, sleep disorders have become increasingly prevalent in China due to changing modern lifestyles and intensified social competition, with generally poor sleep quality across the population. How to improve sleep quality and enhance the quality of life and daytime functioning for insomnia patients has become a significant social concern.

On September 21st, the "2025 China Sleep Medicine Development Forum" was held in Beijing, hosted by the Chinese Sleep Research Association, with the theme "Witnessing the Power of Quality Sleep." During the forum, several experts and scholars shared cutting-edge academic reports on insomnia treatment, highlighting that dual orexin receptor antagonists (DORA), represented by daridorexant, have shown significant improvements in efficacy and safety compared to traditional insomnia medications.

According to Professor Wang Zan, Chief Physician of Neurology at The First Hospital of Jilin University, chronic insomnia is diagnosed when insomnia occurs three or more times per week and persists for three months. Additionally, it's necessary to assess whether other physical or psychiatric conditions are present. From a treatment perspective, traditional benzodiazepine receptor agonists (BZRA) may cause side effects including potential tumor risk, increased fall risk, and cognitive impairment. Non-benzodiazepine receptor inhibitors may affect memory, while melatonin medications can cause delayed reactions.

Professor Wang stated that DORA-class insomnia medications, represented by daridorexant, not only address nighttime sleep issues but also maintain good daytime functioning, making them currently the most ideal choice.

SIMCERE PHARMA's daridorexant (Chinese brand name: Kweiviq®, overseas brand name: QUVIVIQ®) received domestic approval on June 17th this year. As a dual orexin receptor antagonist, it is indicated for treating adult insomnia patients characterized by difficulty falling asleep and/or maintaining sleep, and is not classified as a controlled psychiatric substance.

According to overseas and Chinese clinical research results, daridorexant significantly reduces sleep onset latency (LPS, P<0.05), significantly decreases wake time after sleep onset (WASO, P<0.05) with particularly notable improvements in the latter half of the night, while extending subjective total sleep time (sTST, P<0.05), reducing patients' subjective insomnia symptoms. Due to its mechanism of action and 8-hour half-life, patients experience no hangover or drowsiness effects after use, without impacting normal daytime work, study, and life activities, demonstrating good safety with no withdrawal reactions.

In November 2022, SIMCERE PHARMA entered an exclusive licensing agreement with Switzerland's Idorsia company, obtaining exclusive development and commercialization rights for daridorexant in mainland China and Hong Kong and Macau regions. The medication has been approved for marketing in more than ten countries and regions including the United States, United Kingdom, Switzerland, Japan, and Canada.

Professor Wang Yuping, Chief Physician of Neurology at Xuanwu Hospital of Capital Medical University, presented data from daridorexant's Chinese Phase III clinical trial at the conference. She indicated that regarding primary endpoints, 50mg daridorexant significantly improved nighttime sleep maintenance, measured by cumulative wake time after sleep onset (WASO), reducing it by 35 minutes. For secondary endpoints, namely sleep onset period, it shortened the latency period by 36 minutes.

Regarding safety, there were no substantial differences in adverse events between daridorexant and placebo groups, achieving excellent results without increasing morning drowsiness. Patients showed no withdrawal reactions during the discontinuation observation period and no rebound insomnia.

According to the Chinese Sleep Research Association's "2025 China Sleep Health Survey Report," nearly half (48.5%) of Chinese adults experience sleep disturbances, with higher rates among women and increasing prevalence with age. Primary symptoms include difficulty falling asleep, night awakening, and early awakening.

The "Insomnia Diagnosis and Treatment Guidelines (2025 Edition)" published in the Chinese Medical Journal indicates that for medications used to improve sleep quality and/or extend effective sleep time, the primary recommendations based on drug action duration, adverse reactions, and safety are short- to medium-acting benzodiazepine receptor agonists or dual orexin receptor antagonists, followed by other BZRA or melatonin receptor agonists, sedating antidepressants, and combination use of sedating antidepressants. BZRA representative drugs include estazolam, alprazolam, lorazepam, and oxazepam.

Compared to traditional insomnia medications like benzodiazepines and non-benzodiazepines, DORA-class insomnia medications promote natural sleep by inhibiting excessive orexin nervous system activity.

Besides daridorexant, currently approved dual orexin receptor antagonists in China include Eisai's lemborexant (Chinese brand name: Daweike®), which received approval on May 27th this year and has been approved and launched in more than 20 countries and regions globally.

Market research reveals that on the JD platform, Kweiviq® 50mg*20 tablets is priced at 398 yuan, with a daily treatment cost of approximately 19.9 yuan, while Daweike® 5mg*14 tablets*2 boxes is priced at 498 yuan, with a daily treatment cost of approximately 17.97 yuan. Both medications participated in this year's medical insurance catalog adjustment and are included in the "List of Declared Drugs that Passed Preliminary Formal Review for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog and Commercial Insurance Innovative Drug Catalog Adjustment."

According to the Pharmcube database, current DORA-class insomnia medication development pipelines include: Yangzijiang Pharmaceutical's fazadoresant has submitted an NDA to NCDE; HANSOH PHARMA's novel OX2R antagonist HS-10506 is in clinical trial phase; and Bright Pharmaceuticals' OX2R-targeted BrP-01096 is conducting Phase I clinical trials.

From an international perspective, multinational companies including Merck, Johnson & Johnson, and GSK all have strategic positions in this field.