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

Phase 4

Completed

• Conditions: Insomnia
• Interventions: Drug: placebo; Drug: suvorexant

• Registration Number: NCT03034018
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Study Start: 2017-05-25
• Primary Completion: 2020-04-03
• Study Completion: 2020-04-03
• Results First Submitted: 2021-10-01
• Results First Submitted QC: 2021-10-01
• Results First Posted: 2021-10-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo taken at bedtime for four weeks
suvorexant	suvorexant	suvorexant 10-20 mg taken at bedtime for four weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States