Chronic insomnia is defined as difficulty initiating and/or maintaining sleep at least three times a week for a minimum of three months and a significant negative impact on daytime functioning. The analysis of the Phase 3 data provides evidence that daridorexant reduces wakefulness throughout the entire night, while decreasing morning sleepiness and improving daytime functioning and alertness in patients with chronic insomnia disorder.1
Yves Dauvilliers,MD, PhD, Professor of Neurology and Physiology, and Head of the clinical and research activity of the sleep laboratory at the University of Montpellier, France, and investigator in the Phase 3 program with daridorexant, commented: “Reducing wakefulness throughout the night without next-day residual effects are two essential characteristics of the ideal sleeping pill. Daridorexant works throughout the entire night, especially in the second half of the night when patients need it the most. Remarkably, it achieves this without residual drug effects and even improves morning sleepiness.”
Results of the analysis of the Phase 3 studies1,2 In Phase 3 studies, daridorexant significantly reduced polysomnography-determined wake after sleep onset (WASO) versus placebo, with rates of daytime somnolence similar to placebo. This analysis examines the effect of daridorexant on WASO in each 2-hour quarter (Q) of the night (8-h recording), and on next-morning sleepiness, daytime alertness and ability to function (assessed daily using visual analog scales (VAS)), and the correlation between these night and day assessments. Data from 930 patients with insomnia disorder randomized to daridorexant 50 mg (n=310), 25 mg (n=310) or placebo (n=310) for 3 months were analyzed. At Month 1, daridorexant 25 mg and 50 mg significantly decreased WASO versus placebo in Q2, Q3 and Q4. The reductions in each quarter increased progressively over the night and appeared dose-dependent, with a greater effect consistently seen in the daridorexant 50 mg group than in the daridorexant 25 mg. Results were similar at Month 3. VAS scores for next-morning sleepiness, daytime alertness and ability to function improved from Day 1 in all groups and continued to improve over time, also in a dose-dependent manner.
Antonio Olivieri, MD, Chief Medical Officer & Head of Global Medical Affairs, commented: “Residual morning sleepiness has historically been assessed as an important safety endpoint for sleep medications, due to the residual sedation observed for benzodiazepines and Z-drugs and the associated risks. This publication contributes to the growing evidence of the safety and efficacy profile of daridorexant. The correlation observed between improvement in morning sleepiness, better daytime alertness, and better ability to function during the day is indicative of the fact that daridorexant is providing restorative sleep and improved days to patients with insomnia disorder. I believe this can be attributed to the new mechanism of action of dual blockade of the orexin receptors, and to the PK/PD profile of daridorexant resulting from a tailored drug discovery program that targeted a compound with rapid onset of effect and a duration of action sufficient to cover the night but short enough to avoid any negative next-morning residual activity at optimally effective doses.”
Notes to the editor
About daridorexant Daridorexant is Idorsia’s dual orexin receptor antagonist (DORA) which blocks the binding of the wake-promoting orexin neuropeptides. Rather than inducing sleep through broad inhibition of brain activity, daridorexant only blocks the activation of orexin receptors and reduces the overactive wake drive shown in individuals with chronic insomnia. Daridorexant is commercially available as QUVIVIQ in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, Sweden, and Japan, and is approved throughout the EU, and in Hong Kong.
About insomnia Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.3
Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.
Insomnia is a common problem with a prevalence of approximately 10% worldwide. On this basis, and assuming a US adult population of around 250 million, there are approximately 25 million adults in the US who suffer from insomnia.
Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Idorsia’s research has shown that poor-quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.
The goals of managing insomnia are to improve sleep quality and quantity, as well as daytime functioning. Current recommended treatment of insomnia includes sleep hygiene recommendations, cognitive behavioral therapy and pharmacotherapy.
About Yves Dauvilliers Yves Dauvilliers, MD, PhD, a graduate of the University of Montpelier, is a Professor of Neurology and Physiology, and Head of the clinical and research activity of the sleep laboratory at the University of Montpellier, France. He is also Vice-President of the European Narcolepsy Network, Vice-President of the French Sleep Medical and Research Society (SFRMS), and past Vice-President of the EU Restless Legs Syndrome. He is a Study Group Member of the European Sleep Research Society (ESRS) and a Member of American Academy of Sleep Medicine (AASM). He is an internationally renowned sleep specialist with widely recognized clinical/research expertise in sleep disorders. He is author or coauthor of more than 550 papers published in international and national peer-reviewed journals and several book chapters. He has also served as editor of three French books related to sleep medicine and is a member of the editorial board for Sleep Medicine and Sleep Medicine Review.
Prof. Dauvilliers serves as a consultant to Idorsia and was an investigator in the Phase 3 program.
References
Dauvilliers Y et al. Sleep Medicine. 2025. doi: 10.1016/j.sleep.2025.106523
Mignot E et al. Lancet Neurol. 2022;21(2):125-139.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed., Text Revision. American Psychiatric Publishing. 2022.
About Idorsia Idorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients.
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.
Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.
Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).
For further information, please contact: Investor & Media Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com
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