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

Summary

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.

Conditions

• Menopausal Women
• Insomnia

Interventions

BEHAVIORAL

Cognitive behavioral therapy for insomnia (CBT-i)

This is a program called SHUT-i and is composed of six self-guided sessions on a website over 6-9 weeks. Each session will be about 45-60 minutes long. CBT-I involves changing behaviors that cause sleep problems to persist. However, it also includes teaching skills to teach the participant to identify thoughts and feelings that may contribute to sleep problems.

DRUG

Trazodone

Trazodone is a heterocyclic medication that is FDA-approved for depression (starting dose 150mg). An estimated 4 in 5 trazodone prescriptions are for insomnia. Low-dose trazodone's frequent off-label use stems from a long-standing perception that trazodone is an effective and safer sleep aid compared to other drugs despite potential risks documented in small studies. A starting dosage of 25 mg will be used. After 1 week, patients will be instructed to increase the dose as needed to 50mg if tolerated. A second dose adjustment will be made at 4 weeks. At four weeks, study staff will contact participants and review medication adherence, and a standardized checklist will be used to assess ongoing symptoms and side effects and to consider an increase in dose to 100mg.

DRUG

Daridorexant

Daridorexant is a DORA drug. Dual orexin receptor antagonists (DORAs) are the newest class of FDA-approved medications for insomnia based on efficacy data from pivotal clinical trials demonstrating their efficacy for sleep onset and maintenance. A single dose of 50 mg (1 pill each night within 30 minutes of bedtime) was selected based on better efficacy without evidence of higher risks than the 25mg dose. However, 25mg dosage will be instructed if the participant has moderate liver impairment and/or taking a moderate CYP3A4 inhibitor.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Suzanne Bertisch, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

62 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-13

Primary Completion

2031-02-28

Completion

2031-02-28

FDA Drug

Yes

Countries

• United States

Study Locations