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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a healthy woman aged between 40 and 65.
Select...
I have been diagnosed with Insomnia Disorder.
Select...
I experience hot flashes, including at night.
Select...
I am postmenopausal or in the late stage of perimenopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Index Score
Secondary outcome measures
Fasting Plasma Glucose
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
~2120
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,769 Total Patients Enrolled
8 Trials studying Menopause
122,765 Patients Enrolled for Menopause
Shadab Rahman, PhD MPHPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have recently traveled across different time zones.I have been diagnosed with a sleep disorder other than the one being studied.I am not taking any medications that could interfere with the trial treatment.I am willing to stop taking sleep medications during the study.I am a healthy woman aged between 40 and 65.I have been diagnosed with cancer recently.You have ever had bipolar disorder, psychosis, or another serious mental health issue.I am currently using hormone therapy.I have a heart or brain condition that could affect my safety in the trial.I have been diagnosed with Insomnia Disorder.I am extremely obese.You currently have a problem with drinking alcohol or using drugs.I have kidney or liver disease.You drink a lot of coffee or smoke a lot of cigarettes.I am taking medication for pre-diabetes or to make my body more sensitive to insulin.I am currently experiencing a major depressive episode.You work hours outside of the typical daytime schedule.I have been diagnosed with diabetes.You often take sleeping pills.I have been experiencing ongoing sleep problems.I am considered pre-diabetic according to the American Diabetes Association.I experience hot flashes, including at night.You have thoughts of hurting yourself.I am not allergic to suvorexant.I am postmenopausal or in the late stage of perimenopause.I have had surgery recently.Your score on the Insomnia Severity Index (ISI) measure is 15 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: placebo
- Group 2: suvorexant
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age requirement for this study extend beyond 50 years old?
"This research is seeking out individuals older than 40 and younger than 65 to voluntarily participate."
Answered by AI
How can the security of suvorexant be ascertained?
"With the approval of suvorexant as a medical treatment, this drug scored an impressive 3 on Power's safety scale."
Answered by AI
Is there current room in this research for additional participants?
"Indeed, the information hosted on clinicaltrials.gov indicates that this research initiative is currently seeking participants. This study was initially launched on January 6th 2023 and has undergone modifications as recently as February 16th 2023. As of now, 61 patients need to be enrolled from a single site."
Answered by AI
How extensive is the patient population for this research study?
"Indeed, clinicaltrials.gov indicates that this research is currently searching for suitable participants - the trial was uploaded to their database on 6th January 2023 and most recently updated 16th February 2023. 61 people are needed from one single centre of investigation."
Answered by AI
Are there opportunities for me to participate in this clinical experiment?
"This clinical study is recruiting 61 women aged 40-65, who meet the criteria for Insomnia Disorder and have an ISI score of 15 or higher. Additionally, postmenopausal/late perimenopausal patients must be pre-diabetic according to American Diabetes Association guidelines and experience persistent sleep disruption due to hot flashes at night."
Answered by AI
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