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Orexin Antagonist

Suvorexant for Insomnia

Phase 4
Recruiting
Led By Shadab Rahman, PhD MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy women aged 40-65 years
Meets criteria for Insomnia Disorder
Must not have
Diagnosis of other primary sleep disorders
Concomitant medications with drug interaction or co-administration concerns
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial investigates if a drug can reduce insomnia in pre-diabetic midlife women.

Who is the study for?
This trial is for midlife women aged 40-65 who are pre-diabetic, experiencing insomnia and hot flashes, including at night. They should have an Insomnia Severity Index score of ≥15. Women must be postmenopausal or late perimenopausal without serious mental health issues, major organ disease, recent surgery, or use of sleep medications.
What is being tested?
The study tests if Suvorexant can improve sleep in women with pre-diabetes and insomnia compared to a placebo (a pill with no active drug). Participants will not know which treatment they receive to ensure the results are unbiased.
What are the potential side effects?
Suvorexant may cause drowsiness during the day, headaches, dizziness, abnormal dreams or nightmares. It might also lead to complex sleep behaviors like sleepwalking which could increase the risk of injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy woman aged between 40 and 65.
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I have been diagnosed with Insomnia Disorder.
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I experience hot flashes, including at night.
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I am postmenopausal or in the late stage of perimenopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a sleep disorder other than the one being studied.
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I am not taking any medications that could interfere with the trial treatment.
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I am willing to stop taking sleep medications during the study.
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I have been diagnosed with cancer recently.
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I am currently using hormone therapy.
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I have a heart or brain condition that could affect my safety in the trial.
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I am extremely obese.
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I am taking medication for pre-diabetes or to make my body more sensitive to insulin.
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I am currently experiencing a major depressive episode.
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I have been diagnosed with diabetes.
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I am not allergic to suvorexant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index Score
Secondary study objectives
Fasting Plasma Glucose

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: suvorexantExperimental Treatment1 Intervention
20mg taken at bedtime for 4 weeks
Group II: placeboPlacebo Group1 Intervention
placebo taken at bedtime for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
2016
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,405 Total Patients Enrolled
8 Trials studying Menopause
122,681 Patients Enrolled for Menopause
Shadab Rahman, PhD MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Suvorexant (Orexin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05593653 — Phase 4
Menopause Research Study Groups: placebo, suvorexant
Menopause Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05593653 — Phase 4
Suvorexant (Orexin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05593653 — Phase 4
~21 spots leftby Dec 2025
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