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Completed

NCT Number: NCT03034018

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

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.

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Key information

Conditions

Insomnia Dyssomnias Hot Flashes Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suvorexant

Drug

10-20 mg taken at bedtime for four weeks

Other names: Belsomra

Placebo

Drug

placebo taken at bedtime for four weeks

Primary outcomes

  1. Within-person Change in ISI Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2017
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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