QUVIVIQ® - The World’s New Generation Anti-Insomnia Drug – Approved for Launch，Significantly Improves Sleep and Daytime Functioning
Simcere Pharmaceutical (2096.HK) announced that QUVIVIQ® (generic name: Daridorexant Hydrochloride Tablets), an anti-insomnia drug developed in collaboration with Idorsia in Switzerland, has been approved by the National Medical Products Administration for the treatment of adult patients with insomnia characterized by difficulty falling asleep and/or maintaining sleep, with no psychotropic drug control mark.
• The approval of QUVIVIQ® in China was primarily based on a randomized, double-blind, placebo-controlled, multicenter Phase III registration clinical trial (NCT06010693) and Idorsia’s global clinical data.
• The Phase III clinical study in China, led by Professor Yuping Wang from Xuanwu Hospital, Capital Medical University, enrolled a total of 206 patients with insomnia disorder.
• Clinical studies conducted overseas and in China have demonstrated that QUVIVIQ® exhibits outstanding efficacy in improving latency to persistent sleep (LPS), wake after sleep onset (WASO), measured by PSG, and self-reported (subjective) total sleep time (sTST), sleep quality, and daytime functioning in adult patients with insomnia, with favorable safety and tolerability.
• Significant optimization in sleep onset and maintenance: QUVIVIQ® demonstrated statistically significant reductions in both latency to persistent sleep (LPS, P<0.05) and wake after sleep onset (WASO, P<0.05), with particularly notable improvements in the latter half of the night, as objectively measured by PSG.
• Extended total sleep time: QUVIVIQ® significantly extended subjective total sleep time (sTST, P<0.05), with patients reporting reduced subjective insomnia symptoms.
• Enhanced daytime functioning: With its mechanism of action and a half-life of 8 hours, QUVIVIQ® aligns with physiological sleep-wake cycles. The Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ) scores in the QUVIVIQ® 50 mg group were significantly improved compared to those in the placebo group at Months 1 and 3, with no next-day residual sedation, drowsiness, or impairment to daily work, study, or life.
• Favorable safety profile, no withdrawal effects, and no evidence of dependence: No serious adverse events were reported during treatment. No withdrawal symptoms or rebound insomnia were observed upon discontinuation, and no dependence-related findings have been reported post-marketing.
• According to the 2025 China Sleep Health Survey Report by the Chinese Sleep Research Society, nearly half (48.5%) of Chinese adults experience sleep disturbances, with higher prevalence among women and increasing rates with age.
• Primary symptoms include difficulty falling asleep, nighttime awakenings, and early morning awakenings.
Professor Yuping Wang from Xuanwu Hospital, Capital Medical University, stated: “QUVIVIQ® is the first to achieve dual breakthroughs in improving nighttime sleep and enhancing daytime functioning. Results from the Phase III clinical trial in China show particularly significant improvements in sleep maintenance during the latter half of the night, with lower morning drowsiness than placebo—a key unmet need in current insomnia therapies As the new generation anti-insomnia treatment, QUVIVIQ® is poised to bridge the gap for long-term safe insomnia management, heralding the end of an era dominated by dependency and residual effects associated with traditional hypnotics.”
Jinsheng Ren, Chairman and CEO of Simcere Pharmaceutical, commented: “QUVIVIQ® represents a groundbreaking innovation in global sleep medicine. Its launch in China will address the patients’ needs for better sleep quality and daytime functioning. We look forward to bringing this globally recognized therapy to a great number of Chinese patients with insomnia, offering a more effective and safer option to usher in a new era of high-quality sleep.”
André C. Muller, Chief Executive Officer of Idorsia, commented: “We are very happy with the excellent collaboration we have nurtured with Simcere. I want to congratulate everyone at Simcere and the team that supported them from Idorsia. Together they have been able to take QUVIVIQ through to approval at an incredible pace, just 2.5 years since the signing of the license agreement.”
• As the world's new generation anti-insomnia treatment, QUVIVIQ® has been approved in 11 countries/regions, including the U.S., U.K., Switzerland, Canada, and China Hong Kong.
• It is the only dual orexin receptor antagonist (DORA) approved by the European Medicines Agency (EMA) for improving daytime functioning.
• QUVIVIQ® global Phase III data were published in The Lancet Neurology (January 2022)1; the Chinese Guidelines for Diagnosis and Treatment of Insomnia in Adults (2023) awarded QUVIVIQ® a Class IA recommendation; the Chinese Guidelines for Diagnosis and Treatment of Insomnia Disorder, 2nd Edition (2025) lists QUVIVIQ® as a strong recommendation (Grade A evidence).
• Recognizing the market potential of QUVIVIQ® in China, Simcere Pharmaceutical Group and Idorsia have entered into a supplementary agreement to adjust their existing collaboration terms.
• Simcere will make a cash payment of USD 50 million while reducing sales milestones and royalties for QUVIVIQ®.
• This adjustment will more effectively advance the commercialization of QUVIVIQ® and enhance patient access to this innovative insomnia treatment.
• QUVIVIQ® is a best-in-class dual orexin receptor antagonist (DORA) for insomnia.
• Unlike traditional sedative-hypnotic drugs that promote sleep through central nervous system depression, QUVIVIQ® selectively blocks orexin neuropeptides (orexin-A and -B) from binding to their receptors, facilitating sleep onset and maintenance without altering sleep architecture.
• It demonstrates low next-day drowsiness, improves daytime functioning, and is suitable for long-term use, with no evidence of dependence to date.
• On November 15, 2022, Simcere Pharmaceutical entered into an exclusive licensing agreement with Idorsia for the development and commercialization of QUVIVIQ® in Greater China.