NCT02952820

Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder (SUNRISE 2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 971 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.

Detailed description

This is a long-term (approximately 1 year), multicenter, randomized, controlled, double-blind, parallel group study of two doses of lemborexant and placebo in approximately 900 male or female participants with insomnia disorder. Approximately 40% of participants will be age 65 years or older. The study will last a maximum of 60 weeks, and will include a Screening Period, an approximately 54-week Treatment Period (during which study medication will be administered), and a 2-week Follow-up Period. All participants will receive lemborexant for at least 6 months and will receive placebo at some point during the study. Participants will not know which medication they receive (lemborexant or placebo) until the study has been completed, and will not know the timings at which the medication will change.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	lemborexant
DRUG	Placebo

Timeline

• Start date: 2016-11-15
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2016-11-02
• Last updated: 2020-02-06
• Results posted: 2020-01-21

Locations

114 sites across 12 countries: United States, Canada, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Romania, South Korea, Spain

Regulatory

• FDA-regulated drug study