Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

Phase 3

Completed

• Conditions: Insomnia
• Interventions: Drug: Lemborexant; Drug: Lemborexant-matched placebo; Drug: Zolpidem-matched placebo; Drug: Zolpidem tartrate

• Registration Number: NCT02783729
• Lead Sponsor: Eisai Inc.

Brief Summary

This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

Detailed Description

The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for 30 nights 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. Approximately 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.

Study Timeline

• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-26
• Study Start: 2016-05-31
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2018-03
• Disposition First Submitted: 2018-11-26
• Disposition First Submitted QC: 2018-11-26
• Disposition First Posted: 2018-11-27
• Results First Submitted: 2020-01-03
• Results First Submitted QC: 2020-01-31
• Results First Posted: 2020-02-11
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1006

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lemborexant 10 mg	Zolpidem-matched placebo	Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
Lemborexant 5 milligrams (mg)	Zolpidem-matched placebo	Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
Zolpidem tartrate	Zolpidem tartrate	Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
Placebo	Zolpidem-matched placebo	Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
Lemborexant 10 mg	Lemborexant	Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
Lemborexant 5 milligrams (mg)	Lemborexant	Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
Zolpidem tartrate	Lemborexant-matched placebo	Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
Placebo	Lemborexant-matched placebo	Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30	Baseline, Days 29/30	LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30	Baseline, Days 29/30	SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported.
Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30	Baseline, Days 29/30	WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported.
Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30	Baseline, Days 29/30	WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported.

Trial Locations

Locations (95)

Jasper Summit Research LLC; 🇺🇸 Jasper, Alabama, United States

PACT; 🇺🇸 Glendale, Arizona, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

Southern California Research; 🇺🇸 Fountain Valley, California, United States

Pacific Sleep Medicine Services; 🇺🇸 Oceanside, California, United States

Research Center of Southern California; 🇺🇸 Oceanside, California, United States

Orange County Neuropsychiatric Research Center, LLC; 🇺🇸 Orange, California, United States

SDS Clinical Trials, Inc.; 🇺🇸 Orange, California, United States

Artemis Institute For Clinical Research LLC; 🇺🇸 San Diego, California, United States

Pacific Research Network Inc; 🇺🇸 San Diego, California, United States

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