Daridorexant investigated in women during menopausal transition age with insomnia – Idorsia

Idorsia announced the publication of “Efficacy and safety of daridorexant for the treatment of insomnia disorder in women during menopausal transition age: Insights from a randomized controlled trial” in Maturitas, a prestigious international journal of midlife health and beyond. This new analysis of the efficacy and safety of daridorexant in women aged 47–55 years with insomnia disorder – a population representative of the menopausal transition – is based on data from the Phase III randomized controlled trial (NCT03545191) published in Lancet Neurology and provides important insights into the management of insomnia during in midlife women.

One of the most prevalent and burdensome yet under-researched symptoms reported by women in the menopausal transition is sleep disturbance. Multiple factors, including hormonal changes, vasomotor symptoms (e.g. hot flushes, night sweats), psychological changes (e.g. mood symptoms, depression), development of other sleep disorders (e.g. restless legs syndrome, obstructive sleep apnea), and social demands (e.g. caregiving), may contribute, either triggering the onset of or exacerbating preexisting sleep disturbances. Sleep disturbances can have a significant impact on physical and mental health, quality of life, and productivity.

Key findings
Daridorexant 50 mg improved both sleep and daytime functioning compared to placebo.
Change from baseline at Month 3:

• • Wake after sleep onset (WASO) was improved by ~43 minutes.
• • Latency to persistent sleep (LPS) was improved by ~34 minutes.
• • Self-reported total sleep time was improved by ~75 minutes.
• •  Daytime functioning and sleep quality scores were improved.

Furthermore, the incidence of somnolence and fatigue was low and comparable to placebo, and no increase in next-morning sleepiness was observed compared to placebo.

Dr Zoe Schaedel,  GP, British Menopause Society (BMS) Menopause Specialist and co-author of the manuscript, commented: “Insomnia disorder affects approximately one in four women during the menopausal transition, yet is often underdiagnosed and certainly undertreated. This analysis shows that daridorexant 50 mg offered meaningful improvements in sleep and daytime functioning without compromising safety. It is essential that clinicians consider the diagnosis of insomnia disorder when sleep disturbances arise during the menopause transition rather than considering it merely secondary to menopausal symptoms, allowing access to evidence-based treatments.”

New Brigham and Women’s Hospital study
Principal investigators, Dr Bertisch and Dr Redline, from the Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School, have selected daridorexant, Idorsia’s dual orexin receptor antagonist (DORA), to be included in a study, CELESTE, focused on menopause-related insomnia. The study will compare the effectiveness and safety of different approaches to treat menopause-related insomnia, including daridorexant as the only pharmacotherapy approved for the treatment of insomnia. Results will help clinicians and their patients when considering ways to treat menopause-related insomnia.

Delivering on the company’s commitment to advance the science of sleep and insomnia, Idorsia will be providing daridorexant at no cost, to support this ground-breaking study.

Dr. Antonio Olivieri, Chief Medical Officer & Head of Global Medical Affairs at Idorsia commented: “We are excited for daridorexant to be included in this important study, as insomnia is associated with numerous serious health conditions, and is particularly common in women dealing with menopause. Daridorexant works differently from other insomnia medications by decreasing overactive wake signaling, which is a key cause of insomnia. We look forward to seeing the results and continuing to advance the science of insomnia.”

About the CELESTE study NCT07136415
Funded by the Patient-Centered Outcomes Research Institute (PCORI), the CELESTE study will include around 900 peri- and post-menopausal women with insomnia. Participants will receive treatment for 12 months and insomnia symptoms will be measured using surveys at the start of the study and again three, six and 12 months later. Treatments, including daridorexant, which is approved by the FDA for adults with insomnia, will be monitored to see if they work differently based on factors such the severity of hot flashes, presence of sleep apnea, and menopause stage. The study will be randomized with daridorexant being one of the three-arm study and is expected to be conducted over a 60-month period.

See- Schaedel Z,  Bakker TR  et al.  Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial,
Maturitas 2025, Available online 23 December 2025, 108821 In Press, Journal Pre-proof  https://doi.org/10.1016/j.maturitas.2025.108821.