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

Insomnia, or trouble sleeping, is common. It affects about 1 in 10 adults. People with insomnia are not happy with how long or how well they sleep. Insomnia has been linked to a higher risk of depression, heart disease, memory problems, and lower quality of life. It can also lead to missing work and having accidents. Sleep problems like insomnia are also common or people going through perimenopause and post-menopause. CBT-I teaches people to change behaviors and thoughts that make it hard to sleep. Daridorexant is an FDA-approved medicine for insomnia. Trazodone is FDA-approved to treat depression, but many doctors also prescribe it to help with sleep. This is called off-label use, which means it is used for a purpose the FDA has not officially approved. Studies show that trazodone is one of the most common medicines prescribed for insomnia in the United States. We do not yet know how well CBT-I, trazodone, and daridorexant compare, especially for people in perimenopause and post-menopause. Throughout the duration of the study, the participant will be given one of the three therapies. This study takes about 12 months to complete for each participant. The following visits and procedures will happen: Consent telephone or virtual call Screening Visit: Baseline surveys, urine pregnancy test, electrocardiogram, height and weight assessment. The 7 days after this visit, the participant will also be asked to wear their Fitbit for 24 hours every day, fill out diaries in the morning and night, and wear a home sleep apnea test for one night. Randomization Call: The participant will be randomized (like a flip of a coin) to receive one of the three insomnia therapies (CBT-I, trazodone, or daridorexant) a week after their baseline visit. 1-week and 4-weeks Call: Quick phone call with study staff for any study treatment adjustments. 3-Months and 6-Months Call/Visit: Fill out surveys. At 6-months, weight will be measured. During the visit window, the participant will also be asked to wear their Fitbit for 24 hours every day and fill in a sleep diary in the morning and night for a total of 7 days. 9-Months Call: Quick phone call with study staff to see if there are any issues. 12-Months Call/Visit: Fill out surveys. During the visit window, the participant will also be asked to wear their Fitbit for 24 hours every day and fill in a sleep diary in the morning and night for a total of 7 days. The Fitbit is for the participant to keep and does not have to be returned.