NCT03471871 is a Phase 1 clinical trial of Lemborexant 10 mg in Obstructive Sleep Apnea, sponsored by Eisai Inc..

Who is sponsoring NCT03471871?

NCT03471871 is sponsored by Eisai Inc..

What drugs are being tested in NCT03471871?

Interventions in NCT03471871: Placebo, Lemborexant 10 mg, Lemborexant 25 mg, Placebo, Lemborexant 10 mg.

What condition does NCT03471871 study?

NCT03471871 studies Obstructive Sleep Apnea, Healthy Subjects.

Is NCT03471871 still recruiting?

NCT03471871 is currently completed. Last updated 17 February 2020.

Are results published for NCT03471871?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-02-17 · How we verify

NCT03471871

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea

Completed Phase 1 Results posted Last updated 17 February 2020

What this trial tests

Phase 1 trial testing Placebo in Obstructive Sleep Apnea in 146 participants. Completed in 3 August 2018.

Timeline

21 February 2018

Primary endpoint
3 August 2018

3 August 2018

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	146
Start date	21 February 2018
Primary completion	3 August 2018
Estimated completion	3 August 2018
Sites	11 locations across United States

Drugs / interventions tested

Placebo
Lemborexant 10 mg — full drug profile →
Lemborexant 25 mg — full drug profile →
Placebo
Lemborexant 10 mg — full drug profile →

Conditions studied

Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 90, any sex, with Obstructive Sleep Apnea or Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment Primary · Day 1

SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).

Group	Value	95% CI
HV Cohort: Placebo	95.34	± 0.900
HV Cohort: Lemborexant 10 mg	95.00	± 1.283
HV Cohort: Lemborexant 25 mg	95.07	± 1.311

OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Primary · Day 8

The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.

Group	Value	95% CI
OSA Cohort: Placebo	10.03	± 6.799
OSA Cohort: Lemborexant 10 mg	9.99	± 5.878

HV Cohort: AHI on Day 1 of Treatment Secondary · Day 1

Group	Value	95% CI
HV Cohort: Placebo	4.69	± 8.183
HV Cohort: Lemborexant 10 mg	5.29	± 10.484
HV Cohort: Lemborexant 25 mg	3.55	± 6.585

OSA Cohort: AHI on Day 1 of Treatment Secondary · Day 1

Group	Value	95% CI
OSA Cohort: Placebo	10.24	± 7.094
OSA Cohort: Lemborexant 10 mg	10.29	± 6.681

HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment Secondary · Day 1

TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

SpO2 <90%

Group	Value	95% CI
HV Cohort: Placebo	0.037	± 0.0968
HV Cohort: Lemborexant 10 mg	0.224	± 0.3755
HV Cohort: Lemborexant 25 mg	0.287	± 0.5555

SpO2 <85%

Group	Value	95% CI
HV Cohort: Placebo	0	± 0
HV Cohort: Lemborexant 10 mg	0.004	± 0.0109
HV Cohort: Lemborexant 25 mg	0.047	± 0.1516

SpO2 <80%

Group	Value	95% CI
HV Cohort: Placebo	0	± 0
HV Cohort: Lemborexant 10 mg	0.001	± 0.0034
HV Cohort: Lemborexant 25 mg	0.003	± 0.0077

HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment Secondary · Day 1

Group	Value	95% CI
HV Cohort: Placebo	31.3
HV Cohort: Lemborexant 10 mg	31.3
HV Cohort: Lemborexant 25 mg	37.5

OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment Secondary · Day 1 and Day 8

Day 1

Group	Value	95% CI
OSA Cohort: Placebo	94.53	± 1.620
OSA Cohort: Lemborexant 10 mg	94.54	± 1.470

Day 8

Group	Value	95% CI
OSA Cohort: Placebo	94.46	± 1.316
OSA Cohort: Lemborexant 10 mg	94.65	± 1.539

OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment Secondary · Day 1 and Day 8

Day 1: SpO2 <90%

Group	Value	95% CI
OSA Cohort: Placebo	1.044	± 1.8851
OSA Cohort: Lemborexant 10 mg	1.362	± 2.6170

Day 1: SpO2 <85%

Group	Value	95% CI
OSA Cohort: Placebo	0.104	± 0.3043
OSA Cohort: Lemborexant 10 mg	0.170	± 0.5132

Day 1: SpO2 <80%

Group	Value	95% CI
OSA Cohort: Placebo	0.012	± 0.0483
OSA Cohort: Lemborexant 10 mg	0.014	± 0.0433

Day 8: SpO2 <90%

Group	Value	95% CI
OSA Cohort: Placebo	1.011	± 1.4210
OSA Cohort: Lemborexant 10 mg	1.102	± 1.5469

Day 8: SpO2 <85%

Group	Value	95% CI
OSA Cohort: Placebo	0.109	± 0.2974
OSA Cohort: Lemborexant 10 mg	0.162	± 0.4350

Day 8: SpO2 <80%

Group	Value	95% CI
OSA Cohort: Placebo	0.009	± 0.0366
OSA Cohort: Lemborexant 10 mg	0.015	± 0.0603

OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment Secondary · Day 1 and Day 8

Day 1: SpO2 <90%

Group	Value	95% CI
OSA Cohort: Placebo	67.6
OSA Cohort: Lemborexant 10 mg	75.7

Day 8: SpO2 <90%

Group	Value	95% CI
OSA Cohort: Placebo	75.7
OSA Cohort: Lemborexant 10 mg	83.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to end of follow up visit (up to 67 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HV Cohort: Placebo

Serious: 0/16 (0%)

Deaths: 0/16

HV Cohort: Lemborexant 10 mg

Serious: 0/16 (0%)

Deaths: 0/16

HV Cohort: Lemborexant 25 mg

Serious: 0/17 (0%)

Deaths: 0/17

OSA Cohort: Placebo

Serious: 0/38 (0%)

Deaths: 0/38

OSA Cohort: Lemborexant 10 mg

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (16 terms — click to expand)

Reaction	System	HV Cohort: Placebo	HV Cohort: Lemborexant 10 mg	HV Cohort: Lemborexant 25 mg	OSA Cohort: Placebo	OSA Cohort: Lemborexant 10…
Somnolence	Nervous system disorders	—	—	—	—	—
Photopsia	Eye disorders	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Vaginal infection	Infections and infestations	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Endometriosis	Reproductive system and breast disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03471871 adverse events section.

Sponsor's own description

This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment and to determine whether it increases the apnea-hypopnea index after single and multiple doses of treatment in adult and elderly participants with mild obstructive sleep apnea (OSA).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Respiratory safety of lemborexant in healthy adult and elderly subjects with mild obstructive sleep apnea: A randomized, double-blind, placebo-controlled, crossover study.
Cheng JY, Filippov G, Moline M, Zammit GK, et al · · 2020 · cited 36× · PMID 32187781 · DOI 10.1111/jsr.13021
A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea.
Cheng JY, Lorch D, Lowe AD, Uchimura N, et al · · 2024 · cited 13× · PMID 37677076 · DOI 10.5664/jcsm.10788
The abuse potential of lemborexant, a dual orexin receptor antagonist, according to the 8 factors of the Controlled Substances Act.
Moline M, Asakura S, Beuckman C, Landry I, et al · · 2023 · cited 12× · PMID 36749354 · DOI 10.1007/s00213-023-06320-y
Respiratory safety of lemborexant in adult and elderly subjects with moderate-to-severe chronic obstructive pulmonary disease.
Cheng JY, Lorch D, Hall N, Moline M. · · 2025 · cited 3× · PMID 39266012 · DOI 10.1111/jsr.14334
ACNP 60<sup>th</sup> Annual Meeting: Poster Abstracts P551 - P830.
· 2021 · cited 1× · PMID 34857906 · DOI 10.1038/s41386-021-01238-5
Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea.
Khullar A, Boulos MI, Mak MSB, Moline M, et al · · 2025 · PMID 40848323 · DOI 10.1016/j.sleep.2025.106757

Verify or expand the search:

Other trials of Lemborexant 10 mg

Trials testing the same drug.

NCT06274528 — DORA and LP in Alzheimer's Disease Biomarkers · Phase 2 · recruiting
NCT05458609 — Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep · Phase 3 · completed
NCT04647383 — A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obst · Phase 1 · completed
NCT03001557 — Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia · Phase 2 · completed
NCT02350309 — Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participan · Phase 1 · completed

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting

Other Eisai Inc. trials

Trials by the same sponsor.

NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03471871 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 17 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03471871.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing