Phase 4 N=60 Randomized Quadruple-blind Treatment

Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT03034018 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Within-person Change in ISI Score — -8.1; -5.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: suvorexant (Drug); placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Brigham and Women's Hospital
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Within-person Change in ISI Score	-8.1; -5.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03034018). 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.