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Dual Orexin Receptor Antagonist

Sleep Medications for Healthy Volunteers

Phase < 1
Waitlist Available
Research Sponsored by Walter Reed Army Institute of Research (WRAIR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy males and non-pregnant, non-lactating female volunteers must be between the ages of 18 and 39
Be between 18 and 65 years old
Must not have
Liver disease or significant liver abnormalities
Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days

Summary

This trial is testing two different drugs to see which induces sleep with the least side effects.

Who is the study for?
Healthy English-speaking adults aged 18-39 can join this trial. Women must use birth control if sexually active. Excluded are those with irregular sleep schedules, depression, kidney/liver disease, heavy alcohol/drug use, certain medical conditions or extreme morning/evening preferences.
What is being tested?
The study tests Suvorexant (10 mg) and Zolpidem against a placebo to see which is better for sleep induction without affecting performance. It's randomized and double-blind, meaning participants and researchers don't know who gets which treatment.
What are the potential side effects?
Suvorexant may cause drowsiness or dizziness the next day; Zolpidem might also affect alertness and coordination after waking up. Both drugs could potentially impact memory or mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have liver disease or significant liver problems.
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I use drugs or products that I can't stop during the study.
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I have been diagnosed with narcolepsy and cataplexy.
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I have been hospitalized or on psychiatric medication for over 6 months due to a mental health condition.
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I have kidney disease or significant kidney problems.
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I have a history of a neurological disorder.
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My BMI is 30 or higher, classifying me as obese.
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I have a history of heart disease.
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I use an inhaler daily for my lung condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
consolidation of episodic memory
psychomotor vigilance test

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Zolpidem ArmActive Control2 Interventions
5 mg of Zolpidem
Group II: Suvorexant ArmActive Control2 Interventions
10 mg of Suvorexant
Group III: PlaceboPlacebo Group1 Intervention
10mg of Avicel

Find a Location

Who is running the clinical trial?

Walter Reed Army Institute of Research (WRAIR)Lead Sponsor
107 Previous Clinical Trials
36,684 Total Patients Enrolled

Media Library

Suvorexant (Dual Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04273776 — Phase < 1
Performance Enhancing Drug Use Research Study Groups: Zolpidem Arm, Placebo, Suvorexant Arm
Performance Enhancing Drug Use Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT04273776 — Phase < 1
Suvorexant (Dual Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04273776 — Phase < 1
~15 spots leftby Dec 2025