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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
suvorexant
placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, hot flashes, menopause, suvorexant, belsomra

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

suvorexant

placebo

Arm Description

suvorexant 10-20 mg taken at bedtime for four weeks

placebo taken at bedtime for four weeks

Outcomes

Primary Outcome Measures

Within-person Change in ISI Score
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2017
Last Updated
March 1, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03034018
Brief Title
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Official Title
A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
insomnia, hot flashes, menopause, suvorexant, belsomra

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suvorexant
Arm Type
Experimental
Arm Description
suvorexant 10-20 mg taken at bedtime for four weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo taken at bedtime for four weeks
Intervention Type
Drug
Intervention Name(s)
suvorexant
Other Intervention Name(s)
Belsomra
Intervention Description
10-20 mg taken at bedtime for four weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo taken at bedtime for four weeks
Primary Outcome Measure Information:
Title
Within-person Change in ISI Score
Description
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.
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadine Joffe, MD MSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35022783
Citation
Rahman SA, Nathan MD, Wiley A, Crawford S, Cohn AY, Harder JA, Grant LK, Erickson A, Srivastava A, McCormick K, Bertisch SM, Winkelman JW, Joffe H. A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women. Sleep. 2022 Mar 14;45(3):zsac007. doi: 10.1093/sleep/zsac007.
Results Reference
derived

Learn more about this trial

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

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