Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

The goal of this clinical trial is to learn how three current insomnia therapies (trazodone, daridorexant, cognitive behavioral therapy for insomnia) compare with each other in peri- and post-menopausal women. It will also learn about the safety of the treatments. The main questions it aims to answer are: Which commonly used insomnia therapies are most effective and safe for improving insomnia symptoms in peri- and post-menopausal people? How well do the treatments work for people from different backgrounds, who are at different stages of menopause, and who have different conditions common during menopause (e.g., sleep apnea, mood disturbance, etc.)? What medical problems do participants have when using these treatments? Participants will: Be asked to take trazodone every night, take daridorexant every night, or participate in an online behavioral program for insomnia, for a total of 12 months. Participate in a total of one in-person visit and 7 virtual visits (phone calls) over the 12 months. Wear (and keep) a Fitbit and fill out a daily sleep diary for at least 4 weeks over the 12 months. Fill out online surveys 4 times over the 12 months.

NCT Number	NCT07136415
Lead Sponsor	Brigham and Women's Hospital Collaborators: Patient-Centered Outcomes Research Institute, University of Pittsburgh, University of Utah, Massachusetts General Hospital, Henry Ford Health System, Wake Forest University Health Sciences
Conditions	Menopausal Women, Insomnia
Enrollment	1,000 participants
Start Date	2026-02-13
Primary Completion	2031-02 (estimated)
Study Completion	2031-02 (estimated)
Updated on ClinicalTrials.gov	2026-06-08