A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study

NCT04273776 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: WRAIR #2492
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.

Conditions

Performance Enhancing Product Use

Outcome Measures

Primary Outcomes (2)

• consolidation of episodic memory

  presentation of word lists

  5 days

• psychomotor vigilance test

  measures reaction time

  4 days

Study Arms (3)

Suvorexant Arm

ACTIVE COMPARATOR

10 mg of Suvorexant

Drug: Suvorexant 10 mg; Drug: Placebos

Zolpidem Arm

ACTIVE COMPARATOR

5 mg of Zolpidem

Drug: Zolpidem; Drug: Placebos

Placebo

PLACEBO COMPARATOR

10mg of Avicel

Drug: Placebos

Interventions

Suvorexant 10 mg DRUG

10 mg of suvorexant

Suvorexant Arm

Zolpidem DRUG

5 mg of zolpidem

Zolpidem Arm

Placebos DRUG

Avicel

Placebo; Suvorexant Arm; Zolpidem Arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and non-pregnant, non-lactating female volunteers must be between the ages of 18 and 39
• learned English as a first language (inclusive)\*.
• To be included in the study, volunteers will have to pass a "Volunteer Comprehension Assessment" with a score of 80% or greater. A maximum of two attempts is permitted. See section 5.7 for details.
• Females of child-bearing potential must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.)
• Volunteers must have learned English as their first language. This is because there are cognitive tests administered during the study that require a mastery of the English language.

You may not qualify if:

• Self-reported habitual nightly sleep amounts outside the target range of approximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist).
• Any use of prescription or over-the-counter sleep aids during the 3-month period prior to screening determined by the examining study medical investigator to be indicative of a potential sleep disorder (e.g., use of a sleep aid for several nights following travel across multiple time zones would not necessarily constitute evidence of a sleep disorder).
• Self-reported nighttime lights-out times earlier than 2000 or later than 0100 during weeknights (Sunday through Thursday) (Post-consent Checklist)
• Self-reported morning wake-up times earlier than 0500 or later than 0900 during weekdays (Monday through Friday) (Post-consent Checklist)
• Self-reported habitual napping (\> 3 times a week) in conjunction with normal sleep habits (Post-consent Checklist).
• Self-reported symptoms suggestive of a sleep disorder (including but not limited to insomnia, narcolepsy, sleep disordered breathing/sleep apnea, idiopathic hypersomnia, restless leg syndrome, parasomnias, REM behavior disorder, etc.) (Post-Consent Checklist, Medical History/Exam form; Berlin Questionnaire); history of a sleep disorder (Medical History and Examination) or evidence of such from a prior polysomnographic assessment.
• Objective evidence of narcolepsy + cataplexy using the Ullanlinna Narcolepsy Scale
• Objective evidence of insomnia using the Insomnia Severity Index.
• STATE TRAIT ANXIETY INVENTORY - TRAIT (STAI-T) - Scores above 40.
• MORNING-EVENINGNESS QUESTIONNAIRE -Scores lower than 31 or greater than 69.
• Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or approximately 20 ounces of brewed coffee) per day on average (Post-consent Checklist)
• Score of 14 or above on the Beck Depression Inventory (BDI form)
• History of cardiovascular disease (including but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of myocardial infarction) (Medical History/Exam form)
• Underlying acute or chronic pulmonary disease requiring daily inhaler use (Medical History /Exam form)
• Kidney disease or significant kidney abnormalities (Medical History/Exam form, laboratory results) as determined by examining study medical investigator.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Interventions

suvorexant; Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study sessions will be randomized prior to the study (e.g. Session 1 = placebo, Session 2 = zolpidem, etc.) and volunteers will be assigned a session (treatment group) when they are scheduled for their enrollment visit (Day 1). The randomization schedule will be generated using a random number generator by a person who is not involved in data collection prior to commencement of the study, with the following qualification (hence "pseudo-random"): that all volunteers participating in the same session be randomized or "blocked" together (i.e., assigned the same condition). This will help ensure double-blinding since it may be obvious to volunteers and staff within the same session if some volunteers receive placebo whereas others receive active drug. To help maintain confidentiality, each participant will also be given a unique numerical identifier (e.g., 01-120).
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomization will occur at the level of the study session such that all volunteers participating in the same session will be "blocked" together (i.e., assigned the same condition).

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: December 1, 2019
• Primary Completion: November 21, 2024
• Study Completion: December 12, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)