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

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lemborexant
Placebo
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

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  • Eisai Trail Site 1
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

lemborexant 5 milligrams (mg)

lemborexant 10 mg

Placebo matched to lemborexant

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 31, 2016
Last Updated
January 24, 2020
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02952820
Brief Title
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
971 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lemborexant 5 milligrams (mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
lemborexant 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo matched to lemborexant
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lemborexant
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6
Description
sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
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
Description
sSOL was defined as estimated minutes from time attempted to sleep to sleep onset.
Time Frame
Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3
Title
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
Description
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.
Time Frame
Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
Title
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
Description
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.
Time Frame
Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
Title
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
Description
sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night.
Time Frame
Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6
Title
Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6
Description
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.
Time Frame
Month 6
Title
Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12
Description
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.
Time Frame
Month 12
Title
Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6
Description
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.
Time Frame
Baseline, Months 1, 3, and 6
Title
Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6
Description
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.
Time Frame
Baseline, Months 1, 3 and 6
Title
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
Description
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.
Time Frame
Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6
Title
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)
Time Frame
Baseline, First 7 nights (approximately Week 1) in active treatment period
Title
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
Description
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.
Time Frame
Screening, First and second 7 mornings in follow-up period (Week 52 to 54)
Title
Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12
Description
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.
Time Frame
Baseline, Months 1, 3, 6, 9 and 12
Title
Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period
Description
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.
Time Frame
First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)
Title
Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period
Description
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.
Time Frame
First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)
Title
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
Description
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.
Time Frame
First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)
Title
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
Description
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.
Time Frame
First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)
Title
Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 9, 12
Title
Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1
Description
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.
Time Frame
Baseline, Months 1, 3, 6, 9, and 12
Title
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
Description
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.
Time Frame
Baseline, Month 7, 9, 12
Title
Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7
Description
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.
Time Frame
Baseline, Month 7, 9, 12
Title
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
Description
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.
Time Frame
Baseline, Month 1, 3, 6
Title
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
Description
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.
Time Frame
Baseline, Month 1, 3, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eisai Medical Information
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Facility # 1
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Facility # 2
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Facility # 1
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Facility # 1
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Facility # 2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Facility # 1
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Facility # 1
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Facility # 1
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Facility # 1
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Facility # 1
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Facility # 1
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Facility # 1
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Facility # 1
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Facility # 1
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Facility # 1
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Facility # 1
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Facility # 1
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Innovative Clinical Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Facility # 1
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Facility # 1
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Facility # 1
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Facility # 1
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Facility # 1
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Facility # 1
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Facility # 1
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Facility # 1
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Facility # 1
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
2169
Country
United States
Facility Name
Facility # 1
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Facility # 1
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Facility # 1
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Facility # 1
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Facility # 1
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Facility # 2
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Facility # 1
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Facility # 1
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Facility # 1
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
2865
Country
United States
Facility Name
Facility # 1
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Facility # 1
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Facility # 2
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Facility # 1
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Facility # 1
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Facility # 1
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Facility # 1
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Facility # 1
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Facility # 1
City
Point-Claire
State/Province
Quebec
Country
Canada
Facility Name
Facility # 1
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Facility # 1
City
Oulu
State/Province
Oulun Laani
Country
Finland
Facility Name
Facility # 1
City
Helsinki
Country
Finland
Facility Name
Facility # 1
City
Kuopio
Country
Finland
Facility Name
Facility # 1
City
Tampere
Country
Finland
Facility Name
Facility # 1
City
Turku
Country
Finland
Facility Name
Facility # 2
City
Turku
Country
Finland
Facility Name
Facility # 1
City
Bochum
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Facility # 1
City
Leipzig
State/Province
Sachsen
Country
Germany
Facility Name
Facility # 1
City
Berlin
Country
Germany
Facility Name
Facility # 2
City
Berlin
Country
Germany
Facility Name
Facility # 3
City
Berlin
Country
Germany
Facility Name
Facility # 1
City
Hamburg
Country
Germany
Facility Name
Facility # 1
City
Hannover
Country
Germany
Facility Name
Facility # 1
City
Milano
State/Province
Lombardia
Country
Italy
Facility Name
Facility # 1
City
Siena
State/Province
Toscana
Country
Italy
Facility Name
Facility # 1
City
Roma
Country
Italy
Facility Name
Eisai Trail Site 1
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Eisai Trail Site 1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trail Site 2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trail Site 3
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trail Site 4
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trail Site 1
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site 1
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site 2
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site 3
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trail Site 1
City
Tokorozawa
State/Province
Saitama
Country
Japan
Facility Name
Eisai Trail Site 1
City
Arakawa
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Katsushika
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 2
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Musashino
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Ota
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 2
City
Ota
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 3
City
Ota
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Shibuya
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Shinagawa
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 2
City
Shinagawa
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 2
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trail Site 1
City
Toshima
State/Province
Tokyo
Country
Japan
Facility Name
Facility # 1
City
Seongnam-si
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Facility # 1
City
Suwon
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Facility # 1
City
Daegu
Country
Korea, Republic of
Facility Name
Facility # 1
City
Seoul
Country
Korea, Republic of
Facility Name
Facility # 3
City
Seoul
Country
Korea, Republic of
Facility Name
Facility # 1
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Facility # 1
City
Wellington
State/Province
North Island
Country
New Zealand
Facility Name
Facility # 1
City
Christchurch
State/Province
South Island
Country
New Zealand
Facility Name
Facility # 1
City
Dunedin
State/Province
South Island
Country
New Zealand
Facility Name
Facility # 1
City
Auckland
Country
New Zealand
Facility Name
Facility # 1
City
Rotorua
Country
New Zealand
Facility Name
Facility # 1
City
Tarnow
State/Province
Malopolskie
Country
Poland
Facility Name
Facility # 1
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Facility # 1
City
Gdansk
Country
Poland
Facility Name
Facility # 1
City
Katowice
Country
Poland
Facility Name
Facility # 1
City
Ostroda
Country
Poland
Facility Name
Facility # 2
City
Warszawa
Country
Poland
Facility Name
Facility # 3
City
Warszawa
Country
Poland
Facility Name
Facility # 1
City
Brasov
Country
Romania
Facility Name
Facility # 1
City
Bucharest
Country
Romania
Facility Name
Facility # 1
City
Constanta
Country
Romania
Facility Name
Facility # 1
City
Sibiu
Country
Romania
Facility Name
Facility # 1
City
Targu Mures
Country
Romania
Facility Name
Facility # 1
City
Palma de Mallorca
State/Province
Baleares
Country
Spain
Facility Name
Facility # 1
City
Torrejon de Ardoz
State/Province
Madrid
Country
Spain
Facility Name
Facility # 1
City
Quart de Poblet
State/Province
Valencia
Country
Spain
Facility Name
Facility # 1
City
Barcelona
Country
Spain
Facility Name
Facility # 1
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35402894
Citation
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.
Results Reference
derived
PubMed Identifier
35254948
Citation
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.
Results Reference
derived
PubMed Identifier
35220140
Citation
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.
Results Reference
derived
PubMed Identifier
34077032
Citation
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.
Results Reference
derived
PubMed Identifier
33636648
Citation
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.
Results Reference
derived
PubMed Identifier
33576735
Citation
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.
Results Reference
derived
PubMed Identifier
32585700
Citation
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.
Results Reference
derived

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

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