Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
| Status: | Recruiting |
|---|---|
| Conditions: | Hot Flash, Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 1/18/2019 |
| Start Date: | May 25, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Aleta Wiley, MPH |
| Email: | awiley1@bwh.harvard.edu |
| Phone: | 6170525-9627 |
A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
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.
and postmenopausal women who are experiencing sleep difficulties related to nighttime hot
flashes.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Hadine Joffe, MD, MSc
Phone: 617-525-9627
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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