Insomnia
Conditions
Keywords
insomnia, hot flashes, menopause, suvorexant, belsomra
Brief summary
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
Interventions
DRUGsuvorexant
10-20 mg taken at bedtime for four weeks
DRUGplacebo
placebo taken at bedtime for four weeks
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Peri- or postmenopausal women * DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes * Some awakenings co-occur with a hot flash * Score on the Insomnia Severity Index (ISI) measure ≥15 * Hot flashes present, including at night
Exclusion criteria
* Diagnosis of other primary sleep disorders * Shift workers * Current or expected use of hypnotic medications * Current major depressive episode * Lifetime history of bipolar disorder, psychosis, or other serious mental health problem * Current alcohol/substance use disorder * Obesity * Renal or hepatic disease * Pregnancy or breastfeeding * Recent malignancy * Recent surgery * Neurological disorder or cardiovascular disease raising safety concerns * Medical instability considered to interfere with study procedures * Concomitant medications with drug interaction or co-administration concerns * Contraindications or allergic responses to suvorexant * Recent or planned travel across time zones * Excessive coffee or cigarette use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within-person Change in ISI Score | baseline and 4 weeks | The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suvorexant suvorexant 10-20 mg taken at bedtime for four weeks | 27 |
| Placebo placebo taken at bedtime for four weeks | 29 |
| Total | 56 |
Baseline characteristics
| Characteristic | Suvorexant | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 29 Participants | 56 Participants |
| Age, Continuous | 55.2 years STANDARD_DEVIATION 4.5 | 53.4 years STANDARD_DEVIATION 3.9 | 54.3 years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 25 Participants | 20 Participants | 45 Participants |
| Region of Enrollment United States | 27 participants | 29 participants | 56 participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 56 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 29 |
| other Total, other adverse events | 10 / 27 | 6 / 29 |
| serious Total, serious adverse events | 0 / 27 | 0 / 29 |
Outcome results
Primary
Within-person Change in ISI Score
The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.
Time frame: baseline and 4 weeks
Population: Participants who initiated treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Suvorexant | Within-person Change in ISI Score | -8.1 score on a scale |
| Placebo | Within-person Change in ISI Score | -5.6 score on a scale |