Last updated on February 2018

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder

Brief description of study

The primary objective of this study is to demonstrate using polysomnography (PSG) that 10 mg lemborexant is superior to zolpidem tartrate extended release 6.25 mg (Ambien CR) on objective sleep maintenance as assessed by wake after sleep onset in the second half of the night (WASO2H) after the last 2 nights of treatment in participants 55 years and older with insomnia disorder.

Detailed Study Description

The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.

Clinical Study Identifier: NCT02783729

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Eisai Medical Information

University of Surrey
Guildford, United Kingdom
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