Menopausal WomenPhase 4CELESTENCT07136415
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
A Phase 4 study testing Cognitive behavioral therapy for insomnia (CBT-i), Trazodone and Daridorexant in people with Menopausal Women and Insomnia, run by Brigham and Women's Hospital at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 62 years, women only
- Conditions the study is for
- Menopausal Women, Insomnia
- What is being tested?
- Cognitive behavioral therapy for insomnia (CBT-i), Trazodone and Daridorexant
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Feb 2026to Feb 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Sharon Ng, MS, 617-525-7097, shng1@mgh.harvard.edu
Suzanne Bertisch, MD, MPH
- Recruiting
Henry Ford Medical Center
Novi, Michigan, 48377
Heba Afaneh, 248-344-7363, hafaneh1@hfhs.org
Christopher Drake, PhD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Molly Hundertmark, 412-330-1453, hundertmarkmr2@upmc.edu
Sanjay Patel, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Alesia Booth, 801-585-1767, alesia.booth@hsc.utah.edu
Kelly Baron, PhD, MPH
- Not yet recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103
Hanna Noughani, 801-585-1767, Hanna.Noughani@Advocatehealth.org
Katie Sharkey, MD, PhD
About this study
Official title: CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal People
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Menopausal Women, Insomnia
- Being tested
- Cognitive behavioral therapy for insomnia (CBT-i), Trazodone, Daridorexant
- Keywords
- menopause, insomnia, cognitive behavioral therapy, trazodone, daridorexant
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomnia (CBT-i)Behavioural
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.
TrazodoneDrug
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.
DaridorexantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-i) | Active comparator | Participants will be asked to take part in the CBT-i program over the course of 6-9 weeks, with the option of revisiting content throughout the study duration (12 months). Receives: Behavioral: Cognitive behavioral therapy for insomnia (CBT-i) |
| Trazodone | Active comparator | Participants will be asked to take trazodone (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study. Dosage adjustments may occur. Receives: Drug: Trazodone |
| Daridorexant | Active comparator | Participants will be asked to take daridorexant (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study. Receives: Drug: Daridorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep Disturbance T-score
The primary outcome is PROMIS sleep disturbance, which fulfills the criteria for content validity of a patient-reported outcome with reported relevance, comprehensiveness, ease of use, and treatment responses among people with menopause-related insomnia from diverse geographic locations. Sleep disturbance is one of the most bothersome symptoms of the menopause transition and one of the top reasons health care providers report women seek care.
The PROMIS sleep disturbance scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of sleep disturbance. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Measured: 6 Months
Secondary outcomes (19)
PROMIS Sleep-related Impairment Score
Validated questionnaire assessing daytime alertness. The PROMIS sleep-related impairment scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of sleep-related impairment.
Measured: 6 months
Sleep latency (average)
Measurement of time it takes to fall asleep after going to rest. This is measured in time units (minutes, hours) by self-report and Fitbit. This will be analyzed as a 7-day average.
Measured: 6 months
Client Satisfaction Measure
This is measured via the Client Satisfaction Questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: 6 months
Vasomotor Symptoms
The severity and frequency of vasomotor symptoms assessed via self-report and measured by Likert scale and number of hot flashes per day/night, respectively.
Measured: 6 months
Occurrences of events of special interest and/or adverse events
Occurrence of events of special interest (falls, fall-related injuries, drowsiness, dizziness, headache, nausea, dry mouth, palpitations) will be measured for each arm by self-report or chart review. Occurrence of adverse events will also be assessed by number of participants with treatment-related adverse events as defined by CTCAE v4.0
Measured: Throughout the study duration (up to 1 year)
Number of awakenings
Measure of number of awakenings per night by Fitbit.
Measured: 6 months
Sleep duration
Measured by Fitbit, in hours and minutes.
Measured: 6 months
PROMIS Depression Scale
The PROMIS depression scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of depression symptoms.
Measured: 6 months
PROMIS Anxiety Scale
The PROMIS anxiety scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of anxiety symptoms.
Measured: 6 months
PROMIS Cognitive Function Abilities Scale
The PROMIS cognitive function abilities scale will be used and the possible range of raw score is 4-20. A higher score represents better cognitive function.
Measured: 6 months
PROMIS Anger Scale
The PROMIS anger scale will be used and the possible range of raw score is 5-25. A higher score means higher levels of anger.
Measured: 6 months
PROMISE Global Health Score
The PROMIS global health scale will be used and the possible range of raw score is 8-40. A higher score indicates better physical and mental health.
Measured: 6 months
PROMIS Fatigue Score
The PROMIS fatigue scale will be used and the possible range of raw score is 8-40. A higher score indicates higher levels of fatigue.
Measured: 6 months
PROMIS Interest in Sexual Activity Score
The PROMIS interest in sexual activity scale will be used and the possible range of raw score is 2-10. A higher score indicates greater interest in sexual activity.
Measured: 6 months
PROMIS Satisfaction with Sex Life Score
The PROMIS satisfaction with sex life scale will be used and the possible range of raw score is 4-20. A higher score indicates higher satisfaction with sex life.
Measured: 6 months
Menopause-related Quality of Life
The menopause-related quality of life (MENQOL) scale will be used and the possible range of raw score is 29-232. A higher score indicates higher severity of menopause-related symptoms.
Measured: 6 months
Work Productivity and Activity Impairment
The Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire is a 6-item instrument to measure impairments over the past 7 days in both paid work and unpaid work due to one's health. Higher numbers indicate greater impairment and less productivity. Four main outcomes can be yielded from WPAI and are presented as percentages (0-100%).
Measured: 6 months
Insomnia Severity Index
The Insomnia Severity Index will be used and the possible range of raw score is 0-28. A higher score means more severe symptoms of insomnia.
Measured: 6 months
PROMIS Pain Interference
The PROMIS pain interference scale will be used and the possible range of raw score is 4-20. A higher score means higher levels of pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start13 Feb 2026
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Pittsburgh, University of Utah, Massachusetts General Hospital, Henry Ford Health System, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Suzanne M. Bertisch, MD, MPH, Brigham and Women's Hospital
- Investigators
- Suzanne Bertisch, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136415
- Sponsor's protocol ID
- 2025P001920
- Acronym
- CELESTE
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal People
- ClinicalTrials.gov ID
- NCT07136415
- Acronym / sponsor ID
- CELESTE / 2025P001920
- Conditions
- Menopausal Women, Insomnia
- Keywords
- menopause, insomnia, cognitive behavioral therapy, trazodone, daridorexant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Pittsburgh, University of Utah, Massachusetts General Hospital, Henry Ford Health System, Wake Forest University Health Sciences
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-i) | Active comparator | Behavioral: Cognitive behavioral therapy for insomnia (CBT-i)Participants will be asked to take part in the CBT-i program over the course of 6-9 weeks, with the option of revisiting content throughout the study duration (12 months). |
| Trazodone | Active comparator | Drug: TrazodoneParticipants will be asked to take trazodone (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study. Dosage adjustments may occur. |
| Daridorexant | Active comparator | Drug: DaridorexantParticipants will be asked to take daridorexant (oral pill administration) for the duration of the study (12 months), with safety monitoring conducted by study staff throughout the study. |
Who may qualify
- Ages
- 40 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive behavioral therapy for insomnia (CBT-i) |
| TrazodoneTrazodone 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 | Trazodone |
| DaridorexantDaridorexant 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. | Drug | Daridorexant |
Primary outcome
PROMIS Sleep Disturbance T-score
Time frame: 6 Months
The primary outcome is PROMIS sleep disturbance, which fulfills the criteria for content validity of a patient-reported outcome with reported relevance, comprehensiveness, ease of use, and treatment responses among people with menopause-related insomnia from diverse geographic locations. Sleep disturbance is one of the most bothersome symptoms of the menopause transition and one of the top reasons health care providers report women seek care. The PROMIS sleep disturbance scale will be used and the possible range of raw score is 8-40. A higher score means higher levels of sleep disturbance. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
19 secondary outcomes
PROMIS Sleep-related Impairment Score
Time frame: 6 months
Sleep latency (average)
Time frame: 6 months
Client Satisfaction Measure
Time frame: 6 months
Vasomotor Symptoms
Time frame: 6 months
Occurrences of events of special interest and/or adverse events
Time frame: Throughout the study duration (up to 1 year)
Number of awakenings
Time frame: 6 months
Sleep duration
Time frame: 6 months
PROMIS Depression Scale
Time frame: 6 months
PROMIS Anxiety Scale
Time frame: 6 months
PROMIS Cognitive Function Abilities Scale
Time frame: 6 months
PROMIS Anger Scale
Time frame: 6 months
PROMISE Global Health Score
Time frame: 6 months
PROMIS Fatigue Score
Time frame: 6 months
PROMIS Interest in Sexual Activity Score
Time frame: 6 months
PROMIS Satisfaction with Sex Life Score
Time frame: 6 months
Menopause-related Quality of Life
Time frame: 6 months
Work Productivity and Activity Impairment
Time frame: 6 months
Insomnia Severity Index
Time frame: 6 months
PROMIS Pain Interference
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Bertisch, MD, MPH principal investigator
Brigham and Women's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive behavioral therapy for insomnia (CBT-i), Trazodone and Daridorexant in people with Menopausal Women and Insomnia, run by Brigham and Women's Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Ng, MS (617-525-7097, shng1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Sleep Disturbance T-score (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.