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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
36,674 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons younger than thirty years of age able to participate in this experiment?

"This trial is limited to individuals between the ages of 18 and 39."

Answered by AI

How many people are actively engaging in this experiment?

"Unfortunately, this trial is no longer recruiting. The study originally went live on December 1st 2019 and was last updated November 18th 2022. If you are searching for alternative trials, two studies related to performance-enhancing products currently have open slots along with eighteen clinical investigations focused around Zolpidem Arm that need participants."

Answered by AI

Has recruitment commenced for this research project?

"At present, this medical trial has closed its recruitment process. Originally posted on the 1st of December 2019 and last updated in November 2022, it is no longer accepting participants. If you are searching for other clinical research opportunities, there are presently two studies examining performance enhancing product use and eighteen trials concerning Zolpidem Arm actively enrolling patients."

Answered by AI

Am I eligible to take part in this trial?

"This medical trial is seeking 90 individuals aged 18 to 39 with a history of performance-enhancing product use. To qualify, candidates must pass the 'Volunteer Comprehension Assessment' (VCA) with at least 80% accuracy on their first or second attempt. Additionally, healthy male and female volunteers between these ages may only be included if they are not pregnant or lactating; women who have sexual activity need to take preventive measures against pregnancy. Please read section 5.7 for further details regarding enrollment requirements."

Answered by AI

Have any other studies explored the efficacy of Zolpidem Arm?

"Currently, there are 18 active clinical trials for Zolpidem Arm with two of them in their final phase. The majority of the research is located in Silver Spring, Maryland yet there are 83 other medical centres conducting studies on this drug."

Answered by AI
~24 spots leftby Dec 2025