NCT03158025

A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users

A Randomized, Double-Blind, 6-Way Crossover Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action (suvorexant).

Detailed description

This is a single-center, single oral dose, randomized, double-blind, placebo-controlled, 6-way crossover study in healthy, non-dependent recreational sedative users.

Conditions

• Insomnia Disorders

Interventions

Type	Name	Description
DRUG	Zolpidem tablets	Zolpidem 3 x 10 mg tablets will be administered orally.
DRUG	Suvorexant tablets, over-encapsulated	Suvorexant 2 x 20 mg tablets, over-encapsulated, will be administered orally.
DRUG	Lemborexant tablets	Lemborexant 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg tablets will be administered orally.
DRUG	Placebo lemborexant	Placebo 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg lemborexant tablets will be administered orally.
DRUG	Placebo zolpidem	Placebo 3 x 10 mg zolpidem tablets will be administered orally.
DRUG	Placebo suvorexant	Placebo 2 x 20 mg suvorexant tablets, over-encapsulated, will be administered orally.

Timeline

• Start date: 2017-04-19
• Primary completion: 2018-07-04
• Completion: 2018-07-04
• First posted: 2017-05-17
• Last updated: 2020-06-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study