Study Comparing Digital Therapy, Trazodone, and Daridorexant for Treating Insomnia in Peri- and Post-Menopausal Women

What this Trial Is About

Researchers are evaluating how three common treatments for insomniatrazodone, daridorexant, and cognitive behavioral therapy for insomnia CBT-Icompare in effectiveness and safety for peri- and post-menopausal women. The study aims to understand which therapies work best for improving insomnia symptoms and how they affect people with varying backgrounds, menopause stages, and related health conditions such as sleep apnea and mood disturbances. Participants will be randomly assigned to one of three groups an online CBT-I program lasting 6-9 weeks with ongoing access for 12 months, nightly oral trazodone with dose adjustments over 12 months, or nightly oral daridorexant for 12 months with safety monitoring. Both medications are FDA-approved for related uses, and the study will monitor treatment safety and adherence throughout. Participants will attend one in-person visit and seven virtual visits during the 12-month study. They will complete surveys, wear a Fitbit to track sleep, and keep a daily sleep diary at various times. Safety and side effects will be monitored through phone calls, and at certain visits, weight and other assessments will be conducted. The main measure of success is the PROMIS Sleep Disturbance T-score at 6 months.

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