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A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia

NCT04009577 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-04-12

Study results available
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Summary

The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) after 2 weeks of receiving LEM.

Conditions

Interventions

DRUG

LEM 5 mg

LEM tablet.

DRUG

LEM 10 mg

LEM tablet.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-03-17
Completion
2020-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009577 on ClinicalTrials.gov