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AzTrials

Insomnia DisorderPhase 3NCT02952820

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

A Phase 3 study testing lemborexant in people with Insomnia Disorder, run by Eisai Inc. at 114 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insomnia Disorder
What is being tested?
lemborexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
971 participants
Where
114 sitesin 12 countries
Study dates
15 Nov 2016to 8 Jan 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 18 years or older at the time of informed consent
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder, as follows:
  • 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
  • Duration of complaint ≥3 months
  • Associated with complaint of daytime impairment
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  • History of (Subjective Sleep Onset Latency) sSOL ≥30 minutes on at least 3 nights per week in the previous 4 weeks and/or subjective Wake after Sleep Onset (sWASO) ≥60 minutes on at least 3 nights per week in the previous 4 weeks
  • History of regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
  • Regular bedtime, between 21:00 and 01:00 and regular wake time, the time the participant gets out of bed for the day, between 05:00 and 10:00
  • Insomnia Severity Index (ISI) score ≥15
  • Confirmation of current insomnia symptoms as determined from the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥60 minutes on at least 3 of the 7 nights
  • Confirmation of time spent in bed, as determined from on the Sleep Diary completed on 7 mornings between the first and second screening visit, such that there are not more than 2 nights with duration of time spent in bed 7 hours and 10 hours
  • Confirmation of regular bedtimes and wake times such that the participant has a regular time spent in bed, either sleeping or trying to sleep, between 7 and 10 hours for the final 7 nights of the before visit 3.
  • Confirmation of regular bedtime between 21:00 and 01:00 and time of getting out of bed for the day between 05:00 and 10:00 for the final 7 nights of the before visit 3.
  • Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
  • Willing to not start a behavioral or other treatment program for insomnia during the participants participation in the study

Who cannot join

  • A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia.
  • STOPBang score greater than or equal to (>=) 5
  • International Restless Legs Scale (IRLS) score >=16
  • Epworth Sleepiness Scale (ESS) score >15
  • Reports symptoms potentially related to narcolepsy that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
  • Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior, eg, making phone calls, or preparing and eating food while asleep
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  • For participants who underwent polysomnography (PSG) within the previous year:
  • Age 18 to 64 years: Apnea Hypopnea Index ≥10, or Periodic Limb Movements with Arousal Index ≥10
  • Age ≥65 years: Apnea Hypopnea Index >15, or Periodic Limb Movements with Arousal Index >15
  • Beck Depression Inventory - II (BDI II) score >19 at Screening
  • Beck Anxiety Inventory (BAI) score >15 at Screening
  • Habitually naps more than 3 times per week
  • Females who are breastfeeding or pregnant at Screening or Study Baseline
  • Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.)
  • Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study
  • History of drug or alcohol dependency or abuse within approximately the previous 2 years
  • Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males), or unwilling to limit alcohol intake to no more than 2 drinks per day or forego having alcohol within the 3 hours before bedtime for the duration of his/her participation in the study
  • A prolonged QT/QT interval corrected by Fridericia's formula (QTcF >450 ms) as demonstrated by a repeated electro cardiogram(ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms)
  • Current evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal, neurological [including participants who lack capacity and/or whose cognitive decline indicates disorientation to person/place/time and/or situation], or psychiatric disease or malignancy other than basal cell carcinoma) or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
  • Scheduled for major surgery during the study
  • Used any prohibited prescription or over-the-counter concomitant medications within 1 week before the first dose of study medication
  • Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 2 weeks before Screening
  • Failed treatment with suvorexant (Belsomra®) (efficacy and/or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
  • Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Study Baseline
  • Previously participated in any clinical trial of lemborexant

Trial locations and contacts

114 sites in 12 countries.

114 sites in 12 countries

United States42 sites

  • Facility # 1

    Albuquerque, New Mexico, 87109

  • Facility # 1

    Austin, Texas, 78705

  • Facility # 2

    Austin, Texas, 78731

  • Facility # 1

    Beverly Hills, California, 90210

  • Facility # 1

    Brooklyn, New York, 11235

  • Facility # 1

    Celebration, Florida, 34747

  • Facility # 1

    Chandler, Arizona, 85224

  • Facility # 2

    Chandler, Arizona, 85224

  • Facility # 1

    Colorado Springs, Colorado, 80909

  • Facility # 1

    Dayton, Ohio, 45417

  • Facility # 1

    Elkridge, Maryland, 21075

  • Facility # 1

    Evansville, Indiana, 47714

  • Facility # 1

    Fort Worth, Texas, 76135

  • Facility # 1

    Hialeah, Florida, 33016

  • Facility # 1

    Hickory, North Carolina, 28601

  • Facility # 1

    Homestead, Florida, 33030

  • Facility # 1

    Jacksonville, Florida, 32256

  • Facility # 1

    Kansas City, Missouri, 64114

  • Facility # 1

    Lauderhill, Florida, 33319

  • Facility # 1

    Lincoln, Rhode Island, 2865

  • Facility # 2

    Los Angeles, California, 90048

  • Facility # 1

    Los Angeles, California, 90069

  • Facility # 1

    Maitland, Florida, 32751

  • Facility # 1

    Memphis, Tennessee, 38119

  • Innovative Clinical Research Inc

    Miami, Florida, 33161

  • Facility # 1

    Ocala, Florida, 34471

  • Facility # 2

    Oklahoma City, Oklahoma, 73103

  • Facility # 1

    Oklahoma City, Oklahoma, 73112

  • Facility # 1

    Orlando, Florida, 32801

  • Facility # 1

    Oviedo, Florida, 32765

  • Facility # 1

    Pinellas Park, Florida, 33781

  • Facility # 1

    Portland, Oregon, 97210

  • Facility # 1

    Quincy, Massachusetts, 2169

  • Facility # 1

    Redlands, California, 92374

  • Facility # 1

    Rogers, Arkansas, 72758

  • Facility # 1

    Sacramento, California, 95821

  • Facility # 1

    San Angelo, Texas, 76904

  • Facility # 1

    Santa Monica, California, 90404

  • Facility # 1

    Seattle, Washington, 98101

  • Facility # 1

    Tampa, Florida, 33634

  • Facility # 1

    The Villages, Florida, 32162

  • Facility # 1

    Torrance, California, 90502

Other trials in United States

Japan24 sites

  • Eisai Trail Site 1

    Arakawa City, Tokyo

  • Eisai Trail Site 1

    Katsushika-ku, Tokyo

  • Eisai Trail Site 1

    Maebashi, Gunma

  • Eisai Trail Site 1

    Minato, Tokyo

  • Eisai Trail Site 2

    Minato, Tokyo

  • Eisai Trail Site 1

    Musashino, Tokyo

  • Eisai Trail Site 1

    Ōta-ku, Tokyo

  • Eisai Trail Site 2

    Ōta-ku, Tokyo

  • Eisai Trail Site 3

    Ōta-ku, Tokyo

  • Eisai Trail Site 1

    Sagamihara, Kanagawa

  • Eisai Trail Site 1

    Sapporo, Hokkaido

  • Eisai Trail Site 2

    Sapporo, Hokkaido

  • Eisai Trail Site 3

    Sapporo, Hokkaido

  • Eisai Trail Site 4

    Sapporo, Hokkaido

  • Eisai Trail Site 1

    Shibuya City, Tokyo

  • Eisai Trail Site 1

    Shinagawa, Tokyo

  • Eisai Trail Site 2

    Shinagawa, Tokyo

  • Eisai Trail Site 1

    Shinjuku, Tokyo

  • Eisai Trail Site 2

    Shinjuku, Tokyo

  • Eisai Trail Site 1

    Tokorozawa, Saitama

  • Eisai Trail Site 1

    Toshima City, Tokyo

  • Eisai Trial Site 1

    Yokohama, Kanagawa

  • Eisai Trial Site 2

    Yokohama, Kanagawa

  • Eisai Trial Site 3

    Yokohama, Kanagawa

Other trials in Japan

Germany7 sites

  • Facility # 1

    Berlin

  • Facility # 2

    Berlin

  • Facility # 3

    Berlin

  • Facility # 1

    Bochum, North Rhine-Westphalia

  • Facility # 1

    Hamburg

  • Facility # 1

    Hanover

  • Facility # 1

    Leipzig, Saxony

Other trials in Germany

Poland7 sites

  • Facility # 1

    Gdansk

  • Facility # 1

    Katowice

  • Facility # 1

    Ostróda

  • Facility # 1

    Tarnów, Lesser Poland Voivodeship

  • Facility # 1

    Warsaw, Masovian Voivodeship

  • Facility # 2

    Warsaw

  • Facility # 3

    Warsaw

Other trials in Poland

Finland6 sites

  • Facility # 1

    Helsinki

  • Facility # 1

    Kuopio

  • Facility # 1

    Oulu, Oulun Laani

  • Facility # 1

    Tampere

  • Facility # 1

    Turku

  • Facility # 2

    Turku

Other trials in Finland

New Zealand5 sites

  • Facility # 1

    Auckland

  • Facility # 1

    Christchurch, South Island

  • Facility # 1

    Dunedin, South Island

  • Facility # 1

    Rotorua

  • Facility # 1

    Wellington, North Island

Other trials in New Zealand

Romania5 sites

  • Facility # 1

    Brasov

  • Facility # 1

    Bucharest

  • Facility # 1

    Constanța

  • Facility # 1

    Sibiu

  • Facility # 1

    Târgu Mureş

Other trials in Romania

South Korea5 sites

  • Facility # 1

    Daegu

  • Facility # 1

    Seongnam-si, Gyeonggido

  • Facility # 1

    Seoul

  • Facility # 3

    Seoul

  • Facility # 1

    Suwon, Gyeonggido

Other trials in South Korea

Spain5 sites

  • Facility # 1

    Barcelona

  • Facility # 1

    Palma de Mallorca, Balearic Islands

  • Facility # 1

    Quart de Poblet, Valencia

  • Facility # 1

    Torrejón de Ardoz, Madrid

  • Facility # 1

    Valencia

Other trials in Spain

Canada4 sites

  • Facility # 1

    Kelowna, British Columbia

  • Facility # 1

    Point-Claire, Quebec

  • Facility # 1

    Sherbrooke, Quebec

  • Facility # 1

    Toronto, Ontario

Other trials in Canada

Italy3 sites

  • Facility # 1

    Milan, Lombardy

  • Facility # 1

    Roma

  • Facility # 1

    Siena, Tuscany

Other trials in Italy

Mexico1 site

  • Facility # 1

    Monterrey, Nuevo León

Other trials in Mexico

About this study

Official title: 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)

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.

Read the 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.

Being tested
lemborexant, Placebo
Keywords
insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lemborexantDrug

  • PlaceboDrug

Study groups in NCT02952820
Study groupRoleWhat they receive
lemborexant 5 milligrams (mg)ExperimentalLemborexant 5 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.
Receives: Drug: lemborexant
lemborexant 10 mgExperimentalLemborexant 10 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.
Receives: Drug: lemborexant
Placebo matched to lemborexantPlacebo comparatorLemborexant-matched placebo will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6

    sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.

    Measured: Baseline and Month 6

Secondary outcomes (22)

  1. Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3

    sSOL was defined as estimated minutes from time attempted to sleep to sleep onset.

    Measured: Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3

  2. Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

    sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO.

    Measured: Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6

  3. Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

    sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.

    Measured: Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6

  4. Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

    sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night.

    Measured: Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6

  5. Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6

    Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (>=) 30 minutes and mean sSOL at 6 months was less than or equal to (<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of greater than (>)10 minutes compared to Study Baseline.

    Measured: Month 6

  6. Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12

    Sleep onset responder was defined as follows: sSOL at study Baseline was >=30 minutes and mean sSOL at 6 months was <=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of > 10 minutes compared to study Baseline.

    Measured: Month 12

  7. Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6

    The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16.

    Measured: Baseline, Months 1, 3, and 6

  8. Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6

    The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where "1" indicates strongly disagree and "7", strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63.

    Measured: Baseline, Months 1, 3 and 6

  9. Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

    The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:

    "How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.

    Measured: Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6

  10. Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Active Treatment Period)

    Measured: Baseline, First 7 nights (approximately Week 1) in active treatment period

  11. Change From Screening in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the First and Second 7 Mornings of the Follow-up Period

    The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:

    "How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.

    Measured: Screening, First and second 7 mornings in follow-up period (Week 52 to 54)

  12. Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12

    The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:

    "How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome.

    Measured: Baseline, Months 1, 3, 6, 9 and 12

  13. Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period

    Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.

    Measured: First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)

  14. Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period

    Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.

    Measured: First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)

  15. Rebound Insomnia: Percentage of Participants Whose sSOL Was Longer Than at Screening for First 3 Nights of the Follow-up Period, or Whom Mean sSOL Was Longer Than at Screening for First 7 Nights or Last 7 Nights of the Follow-up Period

    Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.

    Measured: First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)

  16. Rebound Insomnia: Percentage of Participants Whose sWASO is Higher Than at Screening for First 3 Nights of the Follow-up Period, or Whose Mean sWASO is Higher Than at Screening for the First 7 Nights or Last 7 Nights of the Follow-up Period

    Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.

    Measured: First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)

  17. Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1

    sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 1, the change from Baseline was compared to either the lower bound of the 95% CI (for sTST) or the upper bound of the 95% CI (for sSOL and sWASO) at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sTST and below the upper bound of the 95% CI at Month 1 for sSOL and sWASO.

    Measured: Baseline, Month 1, 3, 6, 9, 12

  18. Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1

    sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 1, the change from Baseline was compared to the lower bound of the 95% CI at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sSE.

    Measured: Baseline, Months 1, 3, 6, 9, and 12

  19. Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 9 and 12 Compared to Month 7

    sSOL is defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 7, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sTST and below the upper bound of the 95% CI at Month 7 for sSOL and sWASO.

    Measured: Baseline, Month 7, 9, 12

  20. Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7

    sSE: percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the subject got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 7, the change from Baseline was compared to the lower bound of the 95% CI for sSE at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sSE.

    Measured: Baseline, Month 7, 9, 12

  21. Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 3 and 6 Exposure Compared to Month 1

    sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At 3 and 6 months of exposure, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sTST and below the upper bound of the 95% CI at 1 month of exposure for sSOL and sWASO.

    Measured: Baseline, Month 1, 3, 6

  22. Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSE at Months 3 and 6 Exposure Compared to Month 1

    sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At 3 and 6 months of exposure, the change from Baseline was compared to the lower bound of the 95% CI for sSE at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sSE.

    Measured: Baseline, Month 1, 3, 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completion8 Jan 2019
  4. Study completion8 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
971 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952820
Sponsor's protocol ID
E2006-G000-303
Other IDs
2015-001463-39, 2015
Status last verified
Dec 2017
First submitted
31 Oct 2016
Last updated
6 Feb 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • Suzuki M, Yoshiike T, Khullar A, Kogo Y, Inabe K, Koebis M, Moline M, Cheng JY, Kumar D, Pinner K, Kuriyama K. Effects of lemborexant on sleep quality and its association with morning alertness: Post hoc analysis of two phase 3 trials. Sleep Med X. 2026 Mar 5;11:100183. doi: 10.1016/j.sleepx.2026.100183. eCollection 2026 Dec.

    PubMed 41938624

  • Chepke C, Cote KA, Pinner K, Yardley J, Lundwall C, Moline M. Effect of Lemborexant on Daytime Functioning in Adults With Insomnia: Patient-Reported Outcomes From a Phase 3 Clinical Trial. Prim Care Companion CNS Disord. 2025 Jan 16;27(1):24m03810. doi: 10.4088/PCC.24m03810.

    PubMed 39823487

  • Arnold V, Ancoli-Israel S, Dang-Vu TT, Mishima K, Pinner K, Malhotra M, Moline M. Efficacy of Lemborexant in Adults >/= 65 Years of Age with Insomnia Disorder. Neurol Ther. 2024 Aug;13(4):1081-1098. doi: 10.1007/s40120-024-00622-9. Epub 2024 May 15.

    PubMed 38748321

  • Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.

    PubMed 37796657

  • Terauchi M, Cheng JY, Yardley J, Pinner K, Moline M, Malhotra M, Inabe K, Nishida M, Pappadopulos E. Efficacy and safety of lemborexant in midlife women with insomnia disorder. Menopause. 2023 Aug 1;30(8):839-848. doi: 10.1097/GME.0000000000002209. Epub 2023 Jun 20.

    PubMed 37339396

  • Dash A, Pinner K, Inoue Y, Hayashida K, Lim SC, Yun CH, Lan TH, Huang CL, Yardley J, Kubota N, Moline M. Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder. Sleep Med X. 2022 Mar 24;4:100044. doi: 10.1016/j.sleepx.2022.100044. eCollection 2022 Dec.

    PubMed 35402894

  • Chepke C, Jain R, Rosenberg R, Moline M, Yardley J, Pinner K, Kumar D, Perdomo C, Filippov G, Atkins N, Malhotra M. Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder. Postgrad Med. 2022 Apr;134(3):316-325. doi: 10.1080/00325481.2022.2049553. Epub 2022 Mar 20.

    PubMed 35254948

  • Roth T, Rosenberg R, Morin CM, Yardley J, Pinner K, Perdomo C, Atkins N Jr, Pappadopulos E, Malhotra M, Moline M. Impact of lemborexant treatment on insomnia severity: analyses from a 12-month study of adults with insomnia disorder. Sleep Med. 2022 Feb;90:249-257. doi: 10.1016/j.sleep.2022.01.024. Epub 2022 Feb 8.

    PubMed 35220140

  • Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82:20m13795. doi: 10.4088/JCP.20m13795.

    PubMed 34077032

  • Yardley J, Karppa M, Inoue Y, Pinner K, Perdomo C, Ishikawa K, Filippov G, Kubota N, Moline M. Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial. Sleep Med. 2021 Apr;80:333-342. doi: 10.1016/j.sleep.2021.01.048. Epub 2021 Feb 1.

    PubMed 33636648

  • Inoue Y, Watanabe T, Takashima S, Takase T, Ishikawa K, Kubota N, Yardley J, Moline M. Efficacy and safety of lemborexant in adults with insomnia: comparing Japanese and non-Japanese subgroups from the global, phase 3, randomized, double-blind, placebo-controlled SUNRISE 2 study. J Clin Sleep Med. 2021 May 1;17(5):1067-1074. doi: 10.5664/jcsm.9148.

    PubMed 33576735

  • Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.

    PubMed 32585700

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lemborexant in people with Insomnia Disorder, run by Eisai Inc. at 114 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Japan, Germany, Poland, Finland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02952820, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.

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