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

Recruiting in Palo Alto (17 mi)

+113 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eisai Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eisai Medical Information

Principal Investigator

Eisai Inc.

Eligibility Criteria

Inclusion Criteria

Male or female, age 18 years or older at the time of informed consent

Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep, and/or awakening earlier in the morning than desired despite adequate opportunity for sleep

Frequency of complaint ≥3 times per week

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Treatment Details

Interventions

Lemborexant (Orexin Antagonist)
Placebo (Other)

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: lemborexant 5 milligrams (mg)Experimental Treatment1 Intervention

Lemborexant 5 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Group II: lemborexant 10 mgExperimental Treatment1 Intervention

Lemborexant 10 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Group III: Placebo matched to lemborexantPlacebo Group1 Intervention

Lemborexant-matched placebo will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Lemborexant is already approved in Canada, Japan for the following indications: