On July 25, 2025, Simcere Pharmaceutical Group (2096.HK) announced that the results of the Chinese Phase III clinical trial of QUVIVIQ® (Daridorexant Tablets), a novel dual orexin receptor antagonist (DORA) developed in collaboration with Idorsia, were recently published in SLEEP, the official journal of the Sleep Research Society [1]. This randomized, double-blind, placebo-controlled, multicenter study (NCT06010693) demonstrated that Daridorexant significantly improved multiple insomnia-related parameters, enhancing both sleep quantity and quality without next-morning residual effects. The findings highlight Daridorexant as a potential breakthrough therapy for patients with insomnia in China.
The study, led by Professor Yuping Wang of Xuanwu Hospital, Capital Medical University, enrolled 206 patients with insomnia disorder. Patients were randomized to receive either 50 mg Daridorexant or placebo for one month. Key findings included:
Primary endpoint：Significant improvement in sleep maintenance
Wake After Sleep Onset (WASO) measured by PSG: The Daridorexant group showed significantly greater improvement from baseline compared to the placebo group (-35.0 min vs. -19.5 min, p=0.0009), with particularly notable improvements in the latter half of the night.
Secondary endpoints： improvement in sleep onset and total sleep time:
Latency to Persistent Sleep (LPS) measured by PSG: Daridorexant achieved significantly greater reduction in sleep onset latency versus baseline compared to placebo (-35.7 vs. -22.2 min, p=0.0031).
Subjective Total Sleep Time (sTST) self-reported by the patient: Daridorexant group reported significantly longer subjective sleep time than placebo (50.3 min vs. 33.5 min, p=0.021)
Safety:
Adverse event incidence was comparable between Daridorexant and placebo (21.6% vs. 18.4%). No next-day residual effects, withdrawal symptoms, or rebound insomnia were observed. Daridorexant also yielded significantly lower morning sleepiness scores on the Visual Analog Scale (VAS，higher scores = more sleepiness) versus placebo, suggesting improved morning alertness.
Enhancing Daytime Functioning: Breaking Limitations of Traditional Anti-Insomnia Drugs
Statistics show that 48.5% of Chinese adults suffer from insomnia, representing more than hundreds of million affected individuals. Commonly prescribed sleep medications in China, such as benzodiazepines and non-benzodiazepines, often cause next-day drowsiness, risk of dependence, withdrawal symptoms and rebound insomnia upon discontinuation, as well as potential for addiction. This vast patient population has significant unmet needs for safer and more effective novel insomnia therapies.
Daridorexant targets the core pathophysiology of insomnia by precisely blocking the binding of wake-promoting neuropeptides orexin A/B to their receptors (OX1R/OX2R), thereby suppressing hyperarousal to restore sleep-wake balance. Multiple clinical studies conducted both in China and overseas have shown that Daridorexant preserves the natural sleep architecture by maintaining physiological sleep cycles, in contrast to traditional medications altering the sleep stages, and helps patients achieve restful sleep and refreshed awakening.
Professor Yuping Wang emphasized at the 18th Annual Conference of the Chinese Neurologist Association: "The primary conclusions of Daridorexant Phase3 trial in China align with its previous international multicenter Phase3 results, confirming its ability to significantly reduce sleep onset latency, improve sleep maintenance, provide positive subjective patient experiences, and demonstrate low incidence of next-morning drowsiness. No withdrawal symptoms or rebound insomnia were observed after discontinuation."
The Chinese phase3 study results are overall in consistency with the conclusions made from previous global studies regarding safety and efficacy of Daridorexant.
A study published in January 2022 in The Lancet Neurology [2] showed that the Daridorexant group had significantly lower IDSIQ (Insomnia Daytime Symptoms and Impact Questionnaire) scores compared to the placebo group at Months 1 and 3, with no next-day residual sedation or drowsiness. Additionally, a real-world retrospective analysis of Daridorexant [3] revealed that a total of 78.7% of patients reported an improvement to some degree in daytime symptoms, with nearly one-third of patients overall (32.5%) reporting that their daytime symptoms were nearly or entirely resolved.
The Chinese prescribing information for Daridorexant indicates that it has a half-life of 8 hours, providing a full night coverage aligned with physiological sleep-wake cycles.
Daridorexant was jointly developed by Simcere Pharmaceutical Group and Idorsia in Switzerland. Approved by the National Medical Products Administration on June 17, 2025, it is indicated for adult patients with insomnia characterized by difficulty falling asleep and/or maintaining sleep, and it is not classified as a controlled psychotropic substance. Previously approved for marketing in over ten countries and regions, including the United States, the European Union, the United Kingdom, Switzerland, and Canada, Daridorexant is the first DORA approved by EMA with evidence of improving daytime functioning.