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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004347-39 | EudraCT Number |
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This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.
The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for 30 nights in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. Approximately 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemborexant 5 milligrams (mg) | Experimental | Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night |
|
| Lemborexant 10 mg | Experimental | Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night |
|
| Zolpidem tartrate | Active Comparator | Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night |
|
| Placebo | Placebo Comparator | Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant | Drug | Lemborexant 5 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported. | Baseline, Days 29/30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported. | Baseline, Days 29/30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Body Sway Upon Awakening in the Morning for Lemborexant 5 mg and Lemborexant 10 mg Compared to Zolpidem ER on Days 2/3 | Body sway is detected through a cable around the participant's waist by the ataxia meter. Body sway is measured in units of one-third degree of the angle of arc. For ease in reporting, these are called arbitrary units, with a higher number indicating more body sway (less postural stability). Change from baseline in mean body sway on Days 2 and 3 was reported. |
Inclusion Criteria
Male age 65 years or older or female age 55 years or older at the time of informed consent
Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for Insomnia Disorder, as follows:
History of subjective wake after sleep onset (sWASO) typically ≥ 60 minutes on at least 3 nights per week in the previous 4 weeks
Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 and habitual waketime between 05:00 and 09:00
Insomnia Severity Index (ISI) score ≥ 13
Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary before the second screening visit
Confirmation of regular bedtime and waketime as determined from responses on the Sleep Diary
Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary
Objective (polysomnography [PSG]) evidence of insomnia as follows:
a) Wake after sleep onset (WASO) average ≥ 60 minutes on the 2 consecutive PSGs, with neither night < 45 minutes
Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
Willing not to start a behavioral or other treatment program for the treatment of insomnia during the participant's participation in the study
Exclusion Criteria
A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows:
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
On the Munich Parasomnia Scale (MUPS), endorsed the item that corresponds to a history of sleep-eating or reports a history of sleep-related violent behavior, sleep-driving, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
Apnea-Hypopnea Index > 15 or Periodic Limb Movement with Arousal Index >15 as measured on the PSG at the second screening visit
Beck Depression Inventory - II (BDI-II) score >19 at Screening
Beck Anxiety Index (BAI) score >15 at Screening
Habitually naps during the day more than 3 times per week
Is a female of childbearing potential Note: All females will be considered to be of childbearing potential unless they are postmenopausal (defined as amenorrheic for at least 12 consecutive months, and are postmenopausal without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
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
Known to be positive for human immunodeficiency virus
Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
A prolonged QT/QTcF interval (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated only if initial ECG indicates a QTcF interval >450 ms)
Current evidence of clinically significant disease (e.g., cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; gastrointestinal; severe hepatic impairment; renal including severe renal impairment; neurological including myasthenia gravis; psychiatric disease; or malignancy within the past 5 years other than adequately treated 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, including the ability to perform tasks on the cognitive performance assessment battery (PAB). Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded.
Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessment, including the ability to perform the PAB.
Any suicidal ideation with intent with or without a plan, at the time of or within 6 months before the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) administration during the Prerandomization Phase (i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the eC-SSRS)
Any suicidal behavior in the past 10 years (per the Suicidal Behavior section of the eC-SSRS)
Scheduled for surgery during the study
Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half lives, whichever is longer, before the first dose of study medication (Run-in Period).
Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half-lives, whichever is longer, before the first dose of study medication (Run-in Period)
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 Baseline, or plans to travel across more than 3 time zones during the study
A positive drug test at Screening, Run-In, or Baseline, or unwilling to refrain from use of recreational drugs during the study
Hypersensitivity to lemborexant or zolpidem or to their excipients
Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5× the half-life, whichever is longer preceding informed consent
Previously participated in any clinical trial of lemborexant
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Summit Research LLC | Jasper | Alabama | 35501 | United States | ||
| PACT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41938624 | Derived | 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. | |
| 39879708 |
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A total of 3537 participants were screened, of which 1006 participants were randomized to the treatment period. All participants who were subsequently randomized completed a Run-in Period before randomization to treatment period.
Participants took part in the study at 67 investigative sites in the United States, Spain, Germany, Canada, United Kingdom, and Italy from 31 May 2016 to 30 January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| FG001 | Zolpidem Tartrate Extended Release 6.25 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2018 | Dec 24, 2019 |
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| Lemborexant | Drug | Lemborexant 10 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep. |
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| Lemborexant-matched placebo | Drug | Lemborexant-matched placebo be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep. |
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| Zolpidem tartrate | Drug | Zolpidem tartrate extended release 6.25 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep. |
|
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| Zolpidem-matched placebo | Drug | Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep. |
|
| Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported. | Baseline, Days 29/30 |
| Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30 | WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported. | Baseline, Days 29/30 |
| Baseline, Days 2/3 |
| Change From Baseline in Mean LPS, WASO, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 1/2 and Days 29/30 | LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by the PSG. WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. TST is defined as the amount of sleep in minutes from LPS until terminal awakening as measured by PSG. Change from baseline to average LPS, WASO, and TST on Days 1 and 2, and Days 29 and 30 were reported. | Baseline, Days 1/2, and Days 29/30 |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and Subjective Total Sleep Time (sTST) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with diary handling rules (DHR) on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| Change From Baseline in Subjective Sleep Efficiency (sSE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| Change From Baseline in Mean LPS, WASO, WASO2H, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | LPS: amount of time in minutes from lights off to first epoch of 20 consecutive epochs of non-wakefulness. WASO: amount of time in minutes of wake from the onset of persistent sleep until lights. WASO2H: amount of time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST: amount of time in minutes of sleep from sleep onset until terminal awakening. LPS, WASO, WASO2H, and TST were measured by PSG. Change from baseline to average LPS, WASO, WASO2H, and TST on Day 1 and 2 were reported. | Baseline, Days 1/2 |
| Change From Baseline in Mean SE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | SE is defined as percentage of time spent in bed asleep, calculated as TST divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 1 and 2 were reported. | Baseline, Days 1/2 |
| Change From Baseline in Mean WASO2H and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | WASO2H is defined as the time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST is defined as the amount of sleep in minutes from sleep onset until terminal awakening. WASO and TST were measured by PSG. Change from baseline to average WASO and TST on Day 29 and 30 were reported. | Baseline, Days 29/30 |
| Change From Baseline in Mean sSOL, sWASO, and sTST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo | sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| Change From Baseline in Mean sSE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo | sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| Percentage of Responders With Objective and Subjective Sleep Onset Response, and Objective and Subjective Sleep Maintenance Response | Objective sleep onset response: LPS less than or equal to (<=) 20 minutes (mins) provided baseline LPS was greater than (>) 30 mins. Subjective sleep onset response: sSOL <=20 mins provided mean baseline sSOL was >30 mins. Objective sleep maintenance response: WASO <=60 minutes provided baseline WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective sleep maintenance response: sWASO <=60 mins provided mean WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. Average data for Days 1 and 2, Days 29 and 30, and first and last 7 nights of treatment period was reported. | Days 1/2, Days 29/30, first 7 night (approximately Week 1), and Last seven nights (approximately Week 4) |
| Change From Baseline in Score From Items 4 to 7 on the Insomnia Severity Index (ISI) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER and Placebo on Day 31 | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: severity of sleep onset; sleep maintenance; early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of the sleep problems by others; and 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) yielding a total score from 0 to 28. | Baseline and Day 31 |
| Change From Baseline in Fatigue Severity Scale (FSS) Score of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER and Placebo on Day 31 | The FSS is a self-report scale on which participants are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each of 9 statements about their fatigue where "1" indicates strongly disagree, and "7" indicates strongly agree. The FSS total score was the sum of all responses to the 9 questions. The FSS average item score was the average of the score for each item. Higher total scores and higher average item scores indicated greater fatigue. | Baseline and Day 31 |
| Change From Baseline in Mean Power of Attention (POA) and Speed of Memory Retrieval (SOMT) on Days 2/3 | POA reflects the ability to focus attention and process information. POA is calculated from the sum of simple reaction time, choice reaction time and digit vigilance. SOMT reflects time taken to retrieve information from working and episodic memory. SOMT is a composite score created by combining numerical working memory and spatial working memory and word recognition and picture recognition. Cognitive performance assessment was done by a computerized performance assessment battery (PAB) which was administered on a laptop computer. A positive change from baseline reflects impairment and a lower value of decrease from baseline indicates better performance. Change from baseline to average POA and SOMT on Days 2 and 3 was reported. | Baseline, Days 2/3 |
| Change From Baseline in Mean Quality of Memory (QOM) and Continuity of Attention (COA) on Days 2/3 | QOM represents the ability to store information in memory and subsequently retrieve it. It is a composite score created by combining accuracy measures from 2 sets of working memory and 4 sets of episodic memory. Two sets of working memory were included: numerical and spatial working memory, and ranges from -2 to 2. Four sets of episodic memory were included: immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. COA is the ability to sustain attention. Number of correct responses (out of 50) for choice reaction time was added to total number of targets correctly identified (out of 45) digit vigilance minus number of false alarms (total score of -45 to 95). Higher values were better. Change from baseline to average QOM and COA on Days 2 and 3 was reported. | Baseline, Days 2/3 |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| Carlsbad | California | 92011 | United States |
| Southern California Research | Fountain Valley | California | 92708 | United States |
| Pacific Sleep Medicine Services | Oceanside | California | 92054 | United States |
| Research Center of Southern California | Oceanside | California | 92056 | United States |
| Orange County Neuropsychiatric Research Center, LLC | Orange | California | 92868 | United States |
| SDS Clinical Trials, Inc. | Orange | California | 92868 | United States |
| Artemis Institute For Clinical Research LLC | San Diego | California | 92103 | United States |
| Pacific Research Network Inc | San Diego | California | 92103 | United States |
| Artemis Institute For Clinical Research | San Marcos | California | 92078 | United States |
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | United States |
| Empire Clinical Research | Upland | California | 91786 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Saint Francis Sleep Allergy and Lung Institute | Clearwater | Florida | 33765 | United States |
| Fleming Island Center For Clinical Research | Fleming Island | Florida | 32003 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| QPS MRA | Hollywood | Florida | 33024 | United States |
| Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA) | Miami | Florida | 33143 | United States |
| Research Centers of America | Oakland Park | Florida | United States |
| Compass Research LLC | Orlando | Florida | 32806 | United States |
| NeuroMedical Research Institute | Panama City | Florida | 32405 | United States |
| Clinical Research Group of St Petersburg Inc | St. Petersburg | Florida | 33707 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | United States |
| SleepCare Research Institute Inc | Stockbridge | Georgia | 30281 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Chicago Research Center Inc | Chicago | Illinois | 60634 | United States |
| Helene A Emsellem MD PC | Chevy Chase | Maryland | 20815 | United States |
| Sleep Disorders Center of the Mid-Atlantic | Glen Burnie | Maryland | 21061 | United States |
| Neurocare Inc | Newton | Massachusetts | 02459 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Novi | Michigan | 48377 | United States |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | United States |
| St. Louis Clinical Trials | St Louis | Missouri | 63141 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| CLINiLABS, Inc. | Eatontown | New Jersey | 07724 | United States |
| Winthrop University Hospital | Garden City | New York | 11530 | United States |
| Clinical Research Unit | New York | New York | 10019 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Sleep Medicine Centers of Western New York | West Seneca | New York | 14224 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Wilmington Health Associates | Wilmington | North Carolina | 28401 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Intrepid Research | Cincinnati | Ohio | 45245 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45255 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Cleveland Sleep Research Center | Middleburg Heights | Ohio | 44130 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-3309 | United States |
| Medical University of South Carolina - PPDS | Charleston | South Carolina | 29425 | United States |
| Sleepmed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Pioneer Research Solutions | Houston | Texas | 77099 | United States |
| Sleep Disorders Center of the Mid-Atlantic | Vienna | Virginia | 22182 | United States |
| Seattle | Washington | 98101 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Sleep and Fatigue Institute | Calgary | Alberta | Canada |
| Medical Arts Health Research Group | Kelowna | British Columbia | Canada |
| Markham | Ontario | L3R 1A3 | Canada |
| Somni Research Inc. | Markham | Ontario | Canada |
| Tri Hospital Sleep West | Mississauga | Ontario | Canada |
| Sleep Wake Disorders Clinic | Scarborough Village | Ontario | Canada |
| Toronto | Ontario | M4P 1P2 | Canada |
| Toronto Sleep Institute | Toronto | Ontario | Canada |
| Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin | Bordeaux | France |
| Hopital Gabriel Montpied | Clermont-Ferrand | France |
| CHU Dijon Bourgogne | Dijon | France |
| Hôtel Dieu de Paris Hospital | Paris | France |
| Hopital Civil | Strasbourg | France |
| Zentralinstitut für Seelische Gesundheit | Mannheim | Baden-Wurttemberg | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Schleswig-Holstein | Germany |
| Advanced Sleep Research GmbH | Berlin | Germany |
| Emovis GmbH | Berlin | Germany |
| Studienzentrum Wilhelmshöhe | Kassel | Germany |
| Klinikum rechts der Isar der Technischen Universität München | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH | Schwerin | Germany |
| Ospedale Bellaria | Bologna | Emilia-Romagna | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | Lombardy | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy |
| ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy |
| Fondazione PTV Policlinico Tor Vergata | Roma | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Italy |
| Clinica Universidad de Navarra | Pamplona | Navarre | Spain |
| Hospital San Rafael | A Coruña | Spain |
| Hospital Clinic de Barcelona | Badalona | Spain |
| Barcelona | 08025 | Spain |
| Clinica del Son Estivill | Barcelona | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Instituto de Investigaciones del Sueño | Madrid | Spain |
| Hospital Universitario Araba - Txagorritxu | Vitoria-Gasteiz | Spain |
| Papworth Hospital | Cambridge | Cambridge Shire | United Kingdom |
| University of Surrey | Guildford | Surrey | United Kingdom |
| Guys Hospital | London | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | United Kingdom |
| Kushida CA, Zammit GK, Cheng JY, Kumar D, Moline M. Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea. Sleep Med. 2025 Mar;127:170-177. doi: 10.1016/j.sleep.2024.12.023. Epub 2024 Dec 17. |
| 39120786 | Derived | Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs Aging. 2024 Sep;41(9):741-752. doi: 10.1007/s40266-024-01135-8. Epub 2024 Aug 9. |
| 37796657 | Derived | 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. |
| 36472134 | Derived | Inoue Y, Nishida M, Kubota N, Koebis M, Taninaga T, Muramoto K, Ishikawa K, Moline M. Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended-release for insomnia disorder subtypes defined based on polysomnographic findings. J Clin Sleep Med. 2023 Mar 1;19(3):519-528. doi: 10.5664/jcsm.10378. |
| 35254948 | Derived | 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. |
| 34077032 | Derived | 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. |
| 33590823 | Derived | Moline M, Zammit G, Cheng JY, Perdomo C, Kumar D, Mayleben D. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021 Jun 1;17(6):1167-1174. doi: 10.5664/jcsm.9150. |
| 31880796 | Derived | Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254. |
Participants received zolpidem tartrate extended release (ZOL ER) 6.25 milligram (mg) and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period.
| FG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| FG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| BG001 | Zolpidem Tartrate Extended Release 6.25 mg | Participants received zolpidem tartrate extended release (ZOL ER) 6.25 mg and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period. |
| BG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| BG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Days 29/30 |
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| Secondary | Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported. | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | Percentage of time in bed asleep | Baseline, Days 29/30 |
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| Secondary | Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Days 29/30 |
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| Secondary | Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30 | WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported. | FAS was the group of randomized Participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Days 29/30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean Body Sway Upon Awakening in the Morning for Lemborexant 5 mg and Lemborexant 10 mg Compared to Zolpidem ER on Days 2/3 | Body sway is detected through a cable around the participant's waist by the ataxia meter. Body sway is measured in units of one-third degree of the angle of arc. For ease in reporting, these are called arbitrary units, with a higher number indicating more body sway (less postural stability). Change from baseline in mean body sway on Days 2 and 3 was reported. | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | one-third degree of angle of arc | Baseline, Days 2/3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean LPS, WASO, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 1/2 and Days 29/30 | LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by the PSG. WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. TST is defined as the amount of sleep in minutes from LPS until terminal awakening as measured by PSG. Change from baseline to average LPS, WASO, and TST on Days 1 and 2, and Days 29 and 30 were reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Days 1/2, and Days 29/30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Subjective Sleep Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and Subjective Total Sleep Time (sTST) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with diary handling rules (DHR) on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Subjective Sleep Efficiency (sSE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | % of subjective time in bed asleep | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean LPS, WASO, WASO2H, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | LPS: amount of time in minutes from lights off to first epoch of 20 consecutive epochs of non-wakefulness. WASO: amount of time in minutes of wake from the onset of persistent sleep until lights. WASO2H: amount of time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST: amount of time in minutes of sleep from sleep onset until terminal awakening. LPS, WASO, WASO2H, and TST were measured by PSG. Change from baseline to average LPS, WASO, WASO2H, and TST on Day 1 and 2 were reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. | Posted | Mean | Standard Deviation | minutes | Baseline, Days 1/2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean SE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | SE is defined as percentage of time spent in bed asleep, calculated as TST divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 1 and 2 were reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. | Posted | Mean | Standard Deviation | Percentage of time in bed asleep | Baseline, Days 1/2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean WASO2H and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | WASO2H is defined as the time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST is defined as the amount of sleep in minutes from sleep onset until terminal awakening. WASO and TST were measured by PSG. Change from baseline to average WASO and TST on Day 29 and 30 were reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Days 29/30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean sSOL, sWASO, and sTST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo | sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | minutes | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Mean sSE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo | sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | % of subjective time in bed asleep | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Responders With Objective and Subjective Sleep Onset Response, and Objective and Subjective Sleep Maintenance Response | Objective sleep onset response: LPS less than or equal to (<=) 20 minutes (mins) provided baseline LPS was greater than (>) 30 mins. Subjective sleep onset response: sSOL <=20 mins provided mean baseline sSOL was >30 mins. Objective sleep maintenance response: WASO <=60 minutes provided baseline WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective sleep maintenance response: sWASO <=60 mins provided mean WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. Average data for Days 1 and 2, Days 29 and 30, and first and last 7 nights of treatment period was reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Number | percentage of participants | Days 1/2, Days 29/30, first 7 night (approximately Week 1), and Last seven nights (approximately Week 4) |
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| Other Pre-specified | Change From Baseline in Score From Items 4 to 7 on the Insomnia Severity Index (ISI) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER and Placebo on Day 31 | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: severity of sleep onset; sleep maintenance; early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of the sleep problems by others; and 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) yielding a total score from 0 to 28. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | score on scale | Baseline and Day 31 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Fatigue Severity Scale (FSS) Score of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER and Placebo on Day 31 | The FSS is a self-report scale on which participants are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each of 9 statements about their fatigue where "1" indicates strongly disagree, and "7" indicates strongly agree. The FSS total score was the sum of all responses to the 9 questions. The FSS average item score was the average of the score for each item. Higher total scores and higher average item scores indicated greater fatigue. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | score on scale | Baseline and Day 31 |
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| Other Pre-specified | Change From Baseline in Mean Power of Attention (POA) and Speed of Memory Retrieval (SOMT) on Days 2/3 | POA reflects the ability to focus attention and process information. POA is calculated from the sum of simple reaction time, choice reaction time and digit vigilance. SOMT reflects time taken to retrieve information from working and episodic memory. SOMT is a composite score created by combining numerical working memory and spatial working memory and word recognition and picture recognition. Cognitive performance assessment was done by a computerized performance assessment battery (PAB) which was administered on a laptop computer. A positive change from baseline reflects impairment and a lower value of decrease from baseline indicates better performance. Change from baseline to average POA and SOMT on Days 2 and 3 was reported. | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Posted | Mean | Standard Deviation | millisecond | Baseline, Days 2/3 |
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| Other Pre-specified | Change From Baseline in Mean Quality of Memory (QOM) and Continuity of Attention (COA) on Days 2/3 | QOM represents the ability to store information in memory and subsequently retrieve it. It is a composite score created by combining accuracy measures from 2 sets of working memory and 4 sets of episodic memory. Two sets of working memory were included: numerical and spatial working memory, and ranges from -2 to 2. Four sets of episodic memory were included: immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. COA is the ability to sustain attention. Number of correct responses (out of 50) for choice reaction time was added to total number of targets correctly identified (out of 45) digit vigilance minus number of false alarms (total score of -45 to 95). Higher values were better. Change from baseline to average QOM and COA on Days 2 and 3 was reported. | FAS was group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement at given time points. | Posted | Mean | Standard Deviation | units on scale | Baseline, Days 2/3 |
|
Run-in Phase (Day -7) up to End of treatment (Day 44)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. | 0 | 209 | 0 | 209 | 16 | 209 |
| EG001 | Zolpidem Tartrate Extended Release 6.25 mg | Participants received zolpidem tartrate extended release (ZOL ER) 6.25 mg and lemborexant-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment period. | 0 | 263 | 4 | 263 | 18 | 263 |
| EG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. | 0 | 266 | 2 | 266 | 27 | 266 |
| EG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. | 0 | 268 | 0 | 268 | 28 | 268 |
| EG004 | Run -in Period Placebo | Participants received lemborexant-matched placebo and zolpidem matched placebo, tablets, orally, once on each night for 7 consecutive nights up to Baseline (Day 1), immediately before the time the participant intended to try to sleep of run-in period. | 0 | 1,006 | 0 | 1,006 | 34 | 1,006 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral vascular disorder | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai, Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2018 | Dec 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634104 | lemborexant |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Black or African American |
|
| Japanese |
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| Chinese |
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| Other Asian |
|
| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific |
|
| Other |
|
| Change at Days 29/30 |
|
|
| MMRM |
| < 0.0001 |
Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate. |
| LSGM Ratio |
| 0.723 |
| 2-Sided |
| 95 |
| 0.628 |
| 0.832 |
| Superiority |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period.
|
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Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
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| OG002 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| OG002 |
| Lemborexant 10 mg |
Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| Lemborexant 10 mg |
Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| OG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| OG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| OG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| OG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| Lemborexant 5 mg |
Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| OG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| OG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| OG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
|
|
|
| OG002 | Lemborexant 5 mg | Participants received lemborexant 5 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
| OG003 | Lemborexant 10 mg | Participants received lemborexant 10 mg and zolpidem-matched placebo, tablets, orally, once daily from Day 1 up to Day 30 in the Treatment Period. |
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