drugset / Trial / NCT04009577

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

NCT04009577 ↗

Phase 3 Completed 53 enrolled Eisai Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-07-15
Primary completion
2020-03-17
Completion
2020-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject LEM Unknown 5 mg Oral
Subject LEM Unknown 10 mg Oral

Indications