For many women, the transition into menopause brings ongoing sleep problems, including frequent awakenings, difficulty falling asleep, and interrupted sleep. These changes can begin as early as the mid-30s and can last for years before menopause. According to the National Institutes of Health (NIH), 16% to 47% of women experience sleep disturbances during perimenopause, increasing to 35% to 60% during menopause.
Kelly Baron, PhD, a clinical psychologist in the Division of Public Health, studies how sleep problems affect women during this transition. “Sleep concerns during perimenopause and menopause are very common yet often overlooked,” said Baron.
Researchers from the University of Utah’s Department of Family & Preventive Medicine (DFPM) are contributing to a five-year landmark initiative aimed at enhancing treatment options for women experiencing menopause-related insomnia. Funded by the Patient-Centered Outcomes Research Institute (PCORI), the study is led by Brigham and Women’s Hospital and brings together a collaborative team of researchers from across the country.
Baron and Benjamin Brown, MD, a family medicine physician in the Division of Family and Community Medicine, are leading the university’s involvement in the project. The study, Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms, will evaluate the effectiveness and safety of three existing treatments: self-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I); the antidepressant trazodone; and daridorexant, a medicine that treats insomnia by blocking the brain’s wakefulness-promoting signals.
“We’re excited to contribute to research that prioritizes patient-reported outcomes and real-world effectiveness,” said Baron.
Community partner and advisory board member Maria Jensen shared her own experience with menopause-related sleep problems. “As someone who has struggled with sleep during menopause, I know how frustrating it can be to feel like your concerns aren’t taken seriously,” said Jensen. “Being part of this study means helping shape research that listens to women. It’s empowering to know our voices are guiding the science.”
The study will enroll 891 participants experiencing perimenopausal and early menopausal insomnia symptoms. Researchers will evaluate sleep quality using a standardized patient questionnaire that measures difficulty falling asleep, staying asleep, and satisfaction with sleep. The study will also assess how treatment impacts mood and overall well-being.
Beyond evaluating how well each treatment improves sleep, the study will examine safety outcomes, including side effects such as drowsiness and fall risk. Researchers will also investigate how individual factors—such as demographics, health status, and sleep history—may influence treatment response.
PCORI emphasizes patient-centered research by involving patients, caregivers, and clinicians in shaping study priorities and outcomes. Through this study, DFPM researchers are helping ensure the work focuses on treatments that are accessible, scalable, and grounded in evidence-based research—insights that could help guide better care for those navigating menopause-related sleep problems.