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

Brigham and Women's Hospital
NCT IDNCT07136415ClinicalTrials.gov data as of Apr 2026
Phase

Phase 4

Target enrollment

1,000

Study length

about 5 years

Ages

40–62

Sex

Female only

Locations

5 sites in MA, MI, NC +2

About this study

Researchers are testing whether digital therapy, trazodone, or daridorexant are more effective than each other at treating insomnia in women going through menopause. The trial will also look at the safety of these treatments. Participants will use one of three methods to treat their insomnia for 12 months and provide information about their sleep and health.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Participate in Cognitive behavioral therapy for insomnia (CBT-i)
  • 2.Take Daridorexant
  • 3.Take Trazodone
PhasePhase 4
DrugDaridorexant
Routeoral
Primary goalPROMIS Sleep Disturbance T-score

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

daridorexant, trazodone

Drug routes

oral (Oral Tablet)

Endpoints

Primary: PROMIS Sleep Disturbance T-score

Secondary: Insomnia Severity Index, Menopause-related Quality of Life, Occurrences of events of special interest and/or adverse events, PROMIS Anger Scale, PROMIS Anxiety Scale, PROMIS Cognitive Function Abilities Scale, PROMIS Depression Scale, PROMIS Fatigue Score

Procedures

therapy