CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
suvorexant +1 moredrug
Likely dose
Suvorexant 10-20 mg taken at bedtime for four weeksAI-extracted
Key inclusion· 5
  • ✓Peri- or postmenopausal women
  • ✓DSM-5 insomnia disorder with hot flash attribution
  • ✓Awakenings co-occur with hot flashes
  • ✓Insomnia Severity Index score ≥15
Key exclusion· 13
  • ✕Other primary sleep disorders
  • ✕Shift work employment
  • ✕Current or expected hypnotic use
  • ✕Current major depressive episode

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03034018
NCT03034018Phase 4Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women

Brigham and Women's Hospital·interventional·Posted Jan 27, 2017·Updated Mar 14, 2022

In Brief

A Phase 4 clinical trial evaluating suvorexant and placebo for Insomnia. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartMay 25, 2017
Primary CompletionApr 3, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.4 years ago

Interventions

suvorexantdrug

10-20 mg taken at bedtime for four weeks

placebodrug

placebo taken at bedtime for four weeks