Trial · NCT05594589

A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

NCT05594589, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2025-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder. Trials, record NCT05594589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05594589

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder
NCT number: NCT05594589
Status: Completed
Phases: Phase 2
Enrollment: 65 participants, actual
Lead sponsor: Eisai Co., Ltd.
Conditions: Sleep Initiation and Maintenance Disorders
Interventions: Lemborexant, PBO
First posted: 2022-10-26
Last updated: 2025-07-03
Results first posted: 2025-07-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to Placebo	Baseline, at Day 30	LPS is the duration of time measured from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by polysomnography (PSG).
Secondary	Treatment Period: Change From Baseline in LPS on Day 30 of Lemborexant 10 mg Compared to Placebo	Baseline, at Day 30	LPS is the duration of time measured from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by PSG.
Secondary	Treatment Period: Change From Baseline in Objective Sleep Efficiency (SE) on Day 30 of Lemborexant 5 mg Compared to Placebo	Baseline, at Day 30	SE is defined as total sleep time (TST) divided by time spent in bed multiplied by 100 as measured by PSG. TST is duration of sleep from sleep onset until terminal awakening.
Secondary	Treatment Period: Change From Baseline in Objective SE on Day 30 of Lemborexant 10 mg Compared to Placebo	Baseline, at Day 30	SE is defined as TST divided by time spent in bed multiplied by 100 as measured by PSG. TST is duration of sleep from sleep onset until terminal awakening.
Secondary	Treatment Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of study drug administration at Day 1 up to Day 58	A TEAE was defined as an adverse event (AE) that emerges during treatment (on or after the first dose of study drug up to 28 days after the participant's last dose), having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous.
Secondary	Treatment Period: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	From start of study drug administration at Day 1 up to Day 58	The laboratory parameters included hematology, chemistry, and urinalysis. Any abnormality in the laboratory results which are deemed clinically significant by the investigator were reported.
Secondary	Treatment Period: Number of Participants With Clinically Significant Abnormal Vital Signs Values	From start of study drug administration at Day 1 up to Day 58	Vital sign measurement included systolic and diastolic blood pressure, pulse rate, respiratory rate and body temperature. Any abnormality in vital signs which are deemed clinically significant by the investigator were reported.
Secondary	Treatment Period: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings	From start of study drug administration at Day 1 up to Day 58	Any abnormality in ECG assessments which were deemed clinically significant by the investigator were reported.
Secondary	Treatment Period: Plasma Concentrations of Lemborexant and Its Metabolites (M4, M9, and M10)	Within 2 hours pre-dose on Day 30; At 1 and 1.5 hours after morning waketime on Day 31	Plasma concentrations of lemborexant and its metabolites M4, M9, and M10 were reported.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to Placebo	Baseline, at Day 30	The full analysis set (FAS) included the group of randomized participants who received at least 1 dose of randomized study drug and had LPS data from the PSG on Day 30.	minutes	MEAN
SECONDARY	Treatment Period: Change From Baseline in LPS on Day 30 of Lemborexant 10 mg Compared to Placebo	Baseline, at Day 30	The FAS included the group of randomized participants who received at least 1 dose of randomized study drug and had LPS data from the PSG on Day 30.	minutes	MEAN
SECONDARY	Treatment Period: Change From Baseline in Objective Sleep Efficiency (SE) on Day 30 of Lemborexant 5 mg Compared to Placebo	Baseline, at Day 30	The FAS included the group of randomized participants who received at least 1 dose of randomized study drug and had LPS data from the PSG on Day 30.	percentage of time in bed asleep	MEAN
SECONDARY	Treatment Period: Change From Baseline in Objective SE on Day 30 of Lemborexant 10 mg Compared to Placebo	Baseline, at Day 30	The FAS included the group of randomized participants who received at least 1 dose of randomized study drug and had LPS data from the PSG on Day 30.	percentage of time in bed asleep	MEAN
SECONDARY	Treatment Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of study drug administration at Day 1 up to Day 58	The safety analysis set included participants who received at least 1 dose of randomized study drug and had at least 1 post-dose safety assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment Period: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	From start of study drug administration at Day 1 up to Day 58	The safety analysis set included participants who received at least 1 dose of randomized study drug and had at least 1 post-dose safety assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment Period: Number of Participants With Clinically Significant Abnormal Vital Signs Values	From start of study drug administration at Day 1 up to Day 58	The safety analysis set included participants who received at least 1 dose of randomized study drug and had at least 1 post-dose safety assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment Period: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings	From start of study drug administration at Day 1 up to Day 58	The safety analysis set included participants who received at least 1 dose of randomized study drug and had at least 1 post-dose safety assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Treatment Period: Plasma Concentrations of Lemborexant and Its Metabolites (M4, M9, and M10)	Within 2 hours pre-dose on Day 30; At 1 and 1.5 hours after morning waketime on Day 31	The pharmacokinetic (PK) analysis set included the group of participants who had at least 1 quantifiable plasma concentration of lemborexant or its metabolites, with adequately documented dosing history.	nanogram per milliliter (ng/mL)	MEAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to Placebo	Placebo	-46.12	Standard Deviation 59.006	minutes
Treatment Period: Change From Baseline in Latency to Persistent Sleep (LPS) on Day 30 of Lemborexant 5 mg Compared to Placebo	Lemborexant 5 mg	-50.90	Standard Deviation 55.263	minutes
Treatment Period: Change From Baseline in LPS on Day 30 of Lemborexant 10 mg Compared to Placebo	Placebo	-46.12	Standard Deviation 59.006	minutes
Treatment Period: Change From Baseline in LPS on Day 30 of Lemborexant 10 mg Compared to Placebo	Lemborexant 10 mg	-44.15	Standard Deviation 68.632	minutes
Treatment Period: Change From Baseline in Objective Sleep Efficiency (SE) on Day 30 of Lemborexant 5 mg Compared to Placebo	Placebo	8.32	Standard Deviation 14.730	percentage of time in bed asleep
Treatment Period: Change From Baseline in Objective Sleep Efficiency (SE) on Day 30 of Lemborexant 5 mg Compared to Placebo	Lemborexant 5 mg	15.06	Standard Deviation 12.292	percentage of time in bed asleep
Treatment Period: Change From Baseline in Objective SE on Day 30 of Lemborexant 10 mg Compared to Placebo	Placebo	8.32	Standard Deviation 14.730	percentage of time in bed asleep
Treatment Period: Change From Baseline in Objective SE on Day 30 of Lemborexant 10 mg Compared to Placebo	Lemborexant 10 mg	15.44	Standard Deviation 13.160	percentage of time in bed asleep
Treatment Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Placebo	1		Participants
Treatment Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Lemborexant 5 mg	5		Participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	13
Overall Study	STARTED	Lemborexant 5 mg	26
Overall Study	STARTED	Lemborexant 10 mg	26
Overall Study	Treated During Treatment Period	Placebo	13
Overall Study	Treated During Treatment Period	Lemborexant 5 mg	26
Overall Study	Treated During Treatment Period	Lemborexant 10 mg	26
Overall Study	Placebo Run-in Period	Placebo	65
Overall Study	Placebo Run-in Period	Lemborexant 5 mg	0
Overall Study	Placebo Run-in Period	Lemborexant 10 mg	0
Overall Study	COMPLETED	Placebo	13

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events68

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Postural orthostatic tachycardia syndrome	Cardiac disorders	Run-in Period: Placebo	0	65
other	Postural orthostatic tachycardia syndrome	Cardiac disorders	Treatment Period: Placebo	0	13
other	Postural orthostatic tachycardia syndrome	Cardiac disorders	Treatment Period: Lemborexant 5 mg	1	26
other	Postural orthostatic tachycardia syndrome	Cardiac disorders	Treatment Period: Lemborexant 10 mg	0	26
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Run-in Period: Placebo	0	65
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Treatment Period: Placebo	0	13
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Treatment Period: Lemborexant 5 mg	1	26
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Treatment Period: Lemborexant 10 mg	1	26
other	Dyspepsia	Gastrointestinal disorders	Run-in Period: Placebo	0	65
other	Dyspepsia	Gastrointestinal disorders	Treatment Period: Placebo	0	13

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Run-in Period: Placebo	0	65
Total, all-cause mortality	Treatment Period: Placebo	0	13
Total, all-cause mortality	Treatment Period: Lemborexant 5 mg	0	26
Total, all-cause mortality	Treatment Period: Lemborexant 10 mg	0	26
Total, other adverse events	Run-in Period: Placebo	2	65
Total, other adverse events	Treatment Period: Placebo	1	13
Total, other adverse events	Treatment Period: Lemborexant 5 mg	5	26
Total, other adverse events	Treatment Period: Lemborexant 10 mg	2	26
Total, serious adverse events	Run-in Period: Placebo	0	65
Total, serious adverse events	Treatment Period: Placebo	0	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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