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

A current diagnosis of restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorder, or narcolepsy

Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy

A history of a parasomnia or parasomnia observed on the Screening PSG that in the investigator's opinion makes the participant unsuitable for the study

Periodic Limb Movement with Arousal Index (PLMAI) as measured on the Screening PSG:

1. Age 18 to \<65 years: PLMAI ≥10

2. Age ≥65 years: PLMAI \>15

History of or suspected drug or alcohol use disorder within approximately 2 previous years

A positive urine drug test or breath alcohol test at Screening or Baseline, or unwilling to refrain from use of recreational drugs during the study

Known to be human immunodeficiency virus positive

Active viral hepatitis (B or C) as demonstrated by positive viral serology at Screening

A prolonged QT/corrected QT (QTc) interval (QT interval corrected for heart rate using Fridericia's formula \[QTcF\] \>450 milliseconds \[ms\]) as demonstrated by a repeated electrocardiogram (ECG) at Screening (repeated if initial ECG indicates a QTcF interval \>450 ms)

Comorbid nocturia resulting in the need to get out of bed to use the bathroom more than 3 times during the night

Any history of medical or psychiatric condition that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments

Any suicidal ideation with intent to act with or without a plan, current or within 6 months before the Columbia - Suicide Severity Rating Scale (C-SSRS) administration during the Screening (e.g., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS

Any suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening

Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications

Used any prohibited prescription or over-the-counter medications within 1 week or 5 half-lives, whichever is longer, before the Screening PSG

Hypersensitivity to lemborexant or excipients

Currently enrolled in another interventional clinical trial or used any investigational drug or device within 30 days or 5 times the half-life, whichever is longer preceding informed consent

Previously participated in other clinical trial of lemborexant

Is unable to avoid working a night shift within 2 weeks before the Screening PSG, or between the Screening PSG and End-of-Study

Has travelled across 3 or more time zones in the week prior to Screening, or plans to travel across more than 3 time zones during the study

Clinically significant findings based on vital signs, physical examination, ECG, or clinical laboratory tests

Any valid event of SpO2 \<90% during the Screening PSG

Current evidence of a clinically significant, active respiratory disorder. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease, or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments

Presence of significant illness (including insomnia) that requires treatment or may influence the study assessments (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded

SpO2 less than 80% for ≥ 5% of total sleep time during the Screening PSG

Uses or plans to use of continuous positive airway pressure device or dental appliance within 2 weeks of the Screening PSG (Screening Visit 2) or during the study

Current evidence of a clinically significant, active respiratory disorder other than OSA. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments

Current evidence of other clinically significant disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded. Participants with insomnia disorder, who complain of difficulties with sleep onset and/or sleep maintenance, are eligible provided that they meet this criterion. Note that medications to treat insomnia are prohibited.

What this study is about