Phase 4
Completed N=60
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Source: ClinicalTrials.gov NCT03034018 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Within-person Change in ISI Score — -8.1; -5.6 score on a scale
◆ Published Evidence
Established
21citations · ~5 / year
A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women.
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.
Linked Publications
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A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Within-person Change in ISI Score |
-8.1; -5.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03034018) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.