Menopause-related insomnia affects approximately one in four women during the menopausal transition, yet it remains significantly underdiagnosed and undertreated. A new analysis published in Maturitas journal and reported by The Manilla Times is changing that narrative. Idorsia’s daridorexant, a dual orexin receptor antagonist (DORA), has demonstrated meaningful improvements in both sleep quality and daytime functioning for midlife women struggling with insomnia—offering clinicians and patients a much-needed evidence-based treatment option.
Understanding the Challenge
Sleep disturbance stands as one of the most prevalent yet under-researched symptoms during menopause. The causes are complex and multifaceted: hormonal shifts, vasomotor symptoms like hot flushes and night sweats, mood changes, emerging sleep disorders such as sleep apnea, and increased caregiving demands all converge to disrupt sleep. The consequences extend far beyond nighttime restlessness. Poor sleep during menopause significantly impacts physical and mental health, quality of life, and productivity, making effective treatment essential.
Compelling Study Results
The new analysis examined data from Idorsia’s Phase 3 randomized controlled trial involving women aged 47-55 with insomnia disorder. The results are noteworthy. At three months, the 50 mg dose of daridorexant delivered substantial improvements compared to placebo: wake time after sleep onset decreased by approximately 43 minutes, time to persistent sleep improved by about 34 minutes, and self-reported total sleep time increased by roughly 75 minutes. Beyond these objective measures, daytime functioning and sleep quality scores showed significant improvement.
Importantly, the safety profile was favorable. The incidence of somnolence and fatigue remained low and comparable to placebo, with no increase in next-morning sleepiness, a critical consideration for patients who need to function safely during their days.
A Shift in Clinical Perspective
Dr. Zoe Schaedel, a menopause specialist and co-author of the analysis, emphasizes a critical insight: “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.” This reframing is significant, recognizing menopause-related insomnia as a distinct condition opens the door to targeted, evidence-based interventions rather than dismissing it as an inevitable aspect of menopause.
Expanding the Research
Building on these findings, Brigham and Women’s Hospital, affiliated with Harvard Medical School, is launching the CELESTE study, a landmark investigation funded by the Patient-Centered Outcomes Research Institute. This 60-month study will recruit approximately 900 peri- and post-menopausal women to compare the effectiveness and safety of different treatment approaches for menopausal insomnia, including daridorexant as the only FDA-approved pharmacotherapy. Idorsia is supporting this groundbreaking research by providing daridorexant at no cost.
