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

Recruiting now · Phase 4

Conditions studied: Menopausal Women, Insomnia

In brief

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.

Key facts

Study ID: NCT07136415
Run by: Brigham and Women's Hospital
People needed: 1000
Starts: 2026-02-13
Expected to finish: 2031-02-01
Last updated by the study team: 2026-06-08

Who can join

Age: 40 and older, up to 62. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Age 40-62 years
Assigned female sex at birth
In peri- or early menopause, following the STRAW criteria of self-report of irregular menstrual cycle or within 5 years from the last menstrual period. When menstrual markers are absent or unreliable (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes
Insomnia severity index score > 10 at screening
Insomnia started or worsened during peri- or early menopause
English or Spanish speaking (Spanish-only speaking individuals will be recruited after full development of Spanish-facing materials, which may lag initial study start)

You may not qualify if…

Untreated, previously diagnosed severe sleep apnea (self-report; chart review; clinician assessment)
Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)
Severe daytime sleepiness (Epworth Sleepiness Scale > 15) at screening
Sleep schedule issues that would impact effectiveness of the interventions (e.g., night shift workers with >1 night shift/week; main sleep period outside of 8pm - 11am)
Regular use of hypnotics > 2 nights/week
Limited internet access
Pregnant or lactating or positive urine pregnancy test at baseline visit
Prolonged QTc interval (>460 ms) (by study baseline electrocardiogram (EKG) or EKG report in medical record)
History of the following health conditions: Uncontrolled hypertension; clinically significant heart disease such as arrhythmias requiring medication, cardiomyopathies, heart failure, clinically significant valvular heart disease, or severe coronary artery disease (unstable angina, myocardial infarction in the prior 6 months); hypersomnia or narcolepsy; bipolar disorder, severe depression, or psychosis ; seizure within the past year; use of opioids or substance use disorder; known allergy or contraindication to trazodone or daridorexant (self-report and chart review); known severe chronic liver disease (e.g. cirrhosis); end-stage renal disease on hemodialysis; other severe medical comorbidity (e.g. likely hospitalization within next 6 months or medical conditions that increase risk of participation at a study clinician's discretion)
Use of medications such as those that: Have known potential for significantly prolonging the QT interval (i.e. antiarrhythmics such as amiodarone, sotalol, quinidine, procainamide, dofetilide, and ibutilide), are strong CYP3A4 inhibitors, or are moderate or strong CYP3A4 inducers
Use of one of the interventions in the past 6 months
Other conditions determined by the PI or study clinician to preclude study participation

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
Henry Ford Medical Center — Novi, Michigan, United States (enrolling)
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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