Trial Outcomes & Findings for A Study of Lemborexant in Chinese Participants With Insomnia Disorder (NCT NCT04549168)

Last Updated: 2024-12-20

Results Overview

LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by polysomnography (PSG). Change from baseline to average LPS on Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

194 participants

Primary outcome timeframe

Baseline, Days 29 and 30

Results posted on

2024-12-20

Participant Flow

Participants took part in the study at 21 sites in China mainland and 2 sites in Taiwan from 06 November 2020 to 17 March 2023.

The study consisted of two phases: the prerandomization phase and the randomization phase. A total of 194 participants were enrolled in pre-randomization phase and then went on to randomization phase to receive study treatment.

Participant milestones

Participant milestones
Measure	Prerandomization Phase: All Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day -10 until Day -2.	Randomization Phase: Placebo Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg Participants received one lemborexant 10 milligrams (mg) tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Prerandomization Phase STARTED	194	0	0
Prerandomization Phase COMPLETED	194	0	0
Prerandomization Phase NOT COMPLETED	0	0	0
Randomization Phase STARTED	0	100	94
Randomization Phase Full Analysis Set (FAS)	0	100	93
Randomization Phase COMPLETED	0	96	92
Randomization Phase NOT COMPLETED	0	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomization Phase: Placebo Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg Participants received one lemborexant 10 milligrams (mg) tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Randomization Phase Adverse Event	0	1
Randomization Phase Other	2	0
Randomization Phase Withdrawal by Subject	2	1

Baseline Characteristics

A Study of Lemborexant in Chinese Participants With Insomnia Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomization Phase: Placebo n=100 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=94 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Total n=194 Participants Total of all reporting groups
Age, Customized <55 years old	78 Participants n=5 Participants	73 Participants n=7 Participants	151 Participants n=5 Participants
Age, Customized >=55 - <65 years old	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Age, Customized >=65 - <75 years old	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	58 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	36 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants	94 Participants n=7 Participants	194 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	100 Participants n=5 Participants	94 Participants n=7 Participants	194 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Days 29 and 30

Population: 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. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=89 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=84 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Mean Latency to Persistent Sleep (LPS) Over the Last 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo	-21.71 minutes Standard Deviation 42.809	-39.47 minutes Standard Deviation 46.147

SECONDARY outcome

Timeframe: Baseline, Days 29 and 30

SE was 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 Days 29 and 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=89 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=84 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Mean Objective Sleep Efficiency (SE) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo	7.40 % time (minutes) in bed asleep Standard Deviation 12.853	15.33 % time (minutes) in bed asleep Standard Deviation 11.124

SECONDARY outcome

Timeframe: Baseline, Days 29 and 30

WASO was 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. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=89 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=84 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline in Mean Objective Wake After Sleep Onset (WASO) Over the Last 2 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo	-14.30 minutes Standard Deviation 42.733	-36.65 minutes Standard Deviation 35.342

SECONDARY outcome

Timeframe: Baseline, Nights 24 to 30

Population: The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. Change from baseline to average sSOL of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=98 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=91 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Subjective Sleep Onset Latency (sSOL) Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo	-22.41 minutes Standard Deviation 32.183	-33.10 minutes Standard Deviation 50.060

SECONDARY outcome

Timeframe: Baseline, Nights 24 to 30

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 subjective wake after sleep onset (sWASO). WASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. Change from baseline to average sSE of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=95 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=84 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Subjective Sleep Efficiency (sSE) Over the Last 7 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo	8.88 % of time (minutes) in bed asleep Standard Deviation 11.630	13.16 % of time (minutes) in bed asleep Standard Deviation 16.559

SECONDARY outcome

Timeframe: Baseline, Nights 24 to 30

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 to average sWASO of Nights 24 to 30 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=97 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=88 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline in Subjective Wake After Sleep Onset Over the Last 7 Nights of 1 Month Treatment of Lemborexant 10 mg Compared to Placebo	-22.39 minutes Standard Deviation 48.620	-32.14 minutes Standard Deviation 60.110

SECONDARY outcome

Timeframe: Baseline, Nights 1 and 2

Population: The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement.

LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by polysomnography. Change from baseline to average LPS on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=100 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=93 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Mean Latency to Persistent Sleep Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo	-16.52 minutes Standard Deviation 42.970	-34.64 minutes Standard Deviation 48.102

SECONDARY outcome

Timeframe: Baseline, Nights 1 and 2

Population: 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.

SE was defined as percentage of time spent in bed asleep, calculated as total sleep time divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=100 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=93 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Mean Sleep Efficiency Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo	6.99 % of time (minutes) in bed asleep Standard Deviation 9.595	15.58 % of time (minutes) in bed asleep Standard Deviation 11.725

SECONDARY outcome

Timeframe: Baseline, Nights 1 and 2

Population: 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.

WASO was 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 Nights 1 and 2 was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=100 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=93 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline of Mean Wake After Sleep Onset Over the First 2 Nights of 1 Month of Treatment of Lemborexant 10 mg Compared to Placebo	-17.99 minutes Standard Deviation 29.782	-42.86 minutes Standard Deviation 35.970

SECONDARY outcome

Timeframe: From the first dose of study drug up to 44 days

Population: The safety analysis set was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.

A TEAE was defined as an AE with onset date on or after the first dose of study drug up to 14 days after the last dose of study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening (that is, participant was at immediate risk of death from AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=100 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=94 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	21 Participants	30 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Serious TEAEs	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Day 31

The ISI was a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The 7 dimensions evaluated are 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 is used to rate each item (from 0= no problem, 1= satisfied, 2= moderately satisfied, 3= dissatisfied and 4=very severe problem). Total ISI score was calculated as sum of scores of all 7 individual items, ranging between 0 to 28. A higher score indicated more severe illness. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=89 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=87 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline in Insomnia Severity Index (ISI) Total Score After 1 Month of Treatment With Lemborexant 10 mg Compared to Placebo	-6.48 Score on a scale Standard Deviation 5.246	-9.64 Score on a scale Standard Deviation 5.528

SECONDARY outcome

Timeframe: Baseline to Day 31

The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The 4 dimensions out of 7 evaluated for daily functioning are severity of: 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 is used to rate each item (from 0= no problem, 1= satisfied, 2= moderately satisfied, 3= dissatisfied and 4=very severe problem), Daytime Functioning score was calculated as sum of scores of item 4 to 7, ranging between 0 to 16. A higher score indicated more severe illness. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=89 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=87 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline in Insomnia Severity Index Daytime Functioning Score After 1 Month of Treatment With Lemborexant 10 mg Compared to Placebo	-3.76 Score on a scale Standard Deviation 3.093	-5.77 Score on a scale Standard Deviation 3.510

SECONDARY outcome

Timeframe: First 3 nights (Nights 31 to 33), First 7 nights (Nights 31 to 37) and Last 7 nights (Nights 38 to 44) of Follow up Period

Rebound insomnia was defined as worsened sleep relative to screening after study drug treatment was completed. Sleep diary data from the follow-up period was compared to sleep diary data from the screening period to assess whether participants experience rebound insomnia. Number of participants with rebound insomnia assessed by sleep diary (sSOL and sWASO) was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=94 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=91 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period sWASO, Average of Last 7 nights of follow-up period	8 Participants	12 Participants
Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period sSOL, Average of First 3 nights of follow-up period	5 Participants	7 Participants
Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period sSOL, Average of First 7 nights of follow-up period	6 Participants	7 Participants
Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period sSOL, Average of Last 7 nights of follow-up period	9 Participants	11 Participants
Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period sWASO, Average of First 3 nights of follow-up period	15 Participants	10 Participants
Number of Participants With Rebound Insomnia on Average of First 3 Nights (Nights 31 to 33), Average of First 7 Nights (Nights 31 to 37), and Average of Last 7 Nights (Nights 38 to 44) During the Follow-up Period sWASO, Average First 7 nights of follow-up period	13 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline, First 7 mornings (Mornings 1 to 7) and Last 7 mornings (Mornings 24 to 30) of Treatment period; First 7 mornings (Mornings 31 to 37) and Last 7 mornings (Mornings 38 to 44) of Follow-up period

Population: The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.

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 Likert 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 of the morning sleepiness item on the sleep diary for the average of first 7 mornings and the average of last 7 mornings of the Treatment Period; and the average of the first 7 mornings and the average of the last 7 mornings of the Follow-up Period was reported. The outcome measure was planned to be assessed for randomization phase only.

Outcome measures

Outcome measures
Measure	Randomization Phase: Placebo n=100 Participants Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=93 Participants Participants received one lemborexant 10 mg tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Change From Baseline in Mean Morning Residual Sleepiness Score Evaluated During Treatment and Follow-up Periods First 7 mornings of treatment period	0.20 Score on a scale Standard Deviation 0.982	0.59 Score on a scale Standard Deviation 1.284
Change From Baseline in Mean Morning Residual Sleepiness Score Evaluated During Treatment and Follow-up Periods Last 7 mornings of treatment period	0.75 Score on a scale Standard Deviation 1.577	1.15 Score on a scale Standard Deviation 1.625
Change From Baseline in Mean Morning Residual Sleepiness Score Evaluated During Treatment and Follow-up Periods First 7 mornings of follow-up period	0.81 Score on a scale Standard Deviation 1.508	1.18 Score on a scale Standard Deviation 1.534
Change From Baseline in Mean Morning Residual Sleepiness Score Evaluated During Treatment and Follow-up Periods Last 7 mornings of follow-up period	0.91 Score on a scale Standard Deviation 1.682	1.22 Score on a scale Standard Deviation 1.434

Adverse Events

Prerandomization Phase: All Participants

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Randomization Phase: Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Randomization Phase: Lemborexant 10 mg

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prerandomization Phase: All Participants n=194 participants at risk Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day -10 until Day -2.	Randomization Phase: Placebo n=100 participants at risk Participants received one lemborexant-matched placebo tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.	Randomization Phase: Lemborexant 10 mg n=94 participants at risk Participants received one lemborexant 10 milligrams (mg) tablet, orally, once daily 5 minutes before bedtime at Day 1 until Day 31 (or for 30 consecutive nights) during the Treatment Period and were followed up to Day 44.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	— 0/0 • From signing of the consent form up to 79 days which include 35 days for prerandomization phase and up to 44 days for randomization phase Adverse events were reported for prerandomization and randomization phase.	1.0% 1/100 • From signing of the consent form up to 79 days which include 35 days for prerandomization phase and up to 44 days for randomization phase Adverse events were reported for prerandomization and randomization phase.	0.00% 0/94 • From signing of the consent form up to 79 days which include 35 days for prerandomization phase and up to 44 days for randomization phase Adverse events were reported for prerandomization and randomization phase.

Other adverse events

Additional Information

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