A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
The primary purpose of the study is to determine whether lemborexant increases the apnea
 hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater
 than or equal to [>=] 45 to less than [<] 65 years; elderly >=65 to 90 years) with moderate
 to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry
 determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total
 sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults >=45 to <65
 years; elderly >=65 to 90 years) with moderate to severe chronic obstructive pulmonary
 disease (COPD) compared with placebo.
Inclusion Criteria:

 1. Male or female, age >=45 and <=90 at the time of informed consent

 2. Voluntary agreement and ability to provide written informed consent

 3. Body mass index (BMI) <40 Kilogram per meter square (kg/m^2)

 4. Reports habitually sleeping for at least 5.5 hours per night

 5. Reports habitual bedtime between 21:00 and midnight

 6. Agrees to stay in bed for 7 hours per night for the duration of the study

 7. At Screening Visit 2: Has completed the sleep diary for at least 5 consecutive nights

 8. At Screening Visit 2: Confirmation of mean habitual bedtime (MHB) between 21:00 and
 midnight (sleep diary)

 Additional Inclusion Criteria (OSA Cohort)

 9. Moderate to severe OSA diagnosed according to the criteria of the ICSD, confirmed by
 PSG (home sleep testing by portable monitor is acceptable) within the previous 5 years
 or a repeated PSG during screening

 10. On screening PSG: moderate OSA (defined as 15 <=AHI <30) or severe OSA (defined as AHI
 >=30 per hour)

 11. SpO2 >=94% assessed as part of vital signs at Screening Visit 1

 Additional Inclusion Criteria (COPD Cohort)

 12. Screening spirometry performed as per the Global Initiative for Obstructive Lung
 Disease (GOLD) recommendations

 13. On screening spirometry, based on post-bronchodilator Forced Expiratory Volume in 1
 second (FEV1):

 • FEV1/Forced Vital Capacity (FVC) <0.70 and one of the following:

 -  50% <=FEV1 <80% predicted (GOLD 2 Classification for moderate COPD) or

 -  30% <=FEV1 <50% predicted (GOLD 3 Classification for severe COPD)

 14. Moderate to severe COPD according to medical history and screening spirometry as per
 the GOLD criteria (GOLD 2019)

 15. On screening PSG

 -  AHI <15

 -  SpO2 during wakefulness >90% (both supine and sitting)

 -  SpO2 during sleep >=80% for at least 75% of the recording period with no more
 than five continuous minutes <80% and with no SpO2 readings <70%

 Exclusion Criteria:

 1. Females of childbearing potential

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

 3. 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

 4. A history of symptoms of rapid eye movement (REM) Behavior Disorder, sleep-related
 violent behavior, sleep-driving, or sleep-eating, or symptoms of another parasomnia
 that in the investigator's opinion make the participant unsuitable for the study

 5. Periodic Limb Movement with Arousal Index (PLMAI) as measured on the screening

 PSG:

 -  Age 18 to <65 years: PLMAI >=10

 -  Age >65 years: PLMAI >15

 6. A prolonged QT interval by Fredericia (QTcF) (QTcF >450 milliseconds [ms]) as
 demonstrated by a repeated electrocardiogram (ECG) at Screening

 7. Any suicidal ideation with intent with or without a plan at Screening or within 6
 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal
 Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS])

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

 9. Evidence of clinically significant disease (example, cardiac, respiratory,
 gastrointestinal, renal disease) that in the opinion of the investigator(s) could
 affect the participant's safety or interfere with the study assessments

 10. Hypersensitivity to the study drug or any of the excipients

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

 12. Any history of or concomitant medical condition that in the opinion of the
 investigator(s) would compromise the participant's ability to safely complete the
 study

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

 14. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of
 antipsychotics or prior suicide attempt(s) within approximately the last 2 years

 15. History of drug or alcohol dependency or abuse within approximately the last 2 years

 16. Use of illegal recreational drugs (includes marijuana, regardless of whether
 prescribed for medicinal use)

 17. Currently enrolled in another clinical study or used any investigational drug or
 device within 28 days or 5*the half-life, whichever is longer preceding informed
 consent

 18. Previously participated in other clinical trial of lemborexant

 19. Exposure within the last 14 days to an individual with confirmed or probable corona
 virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most
 recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any
 other reason to consider the participant at potential risk for an acute COVID-19
 infection

 Additional Exclusion Criteria (OSA Cohort)

 20. SpO2 <80% for >=5% of TST during the screening PSG

 21. Use of a continuous positive airway pressure (CPAP) device or dental appliance within
 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP
 device or dental appliance from the

 22. Current evidence of a clinically significant, active respiratory disorder other than
 OSA. This includes bronchiectasis, emphysema, asthma, COPD 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

 23. Current evidence of other clinically significant disease (example, 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. Screening Visit through the last study visit

 Additional Exclusion Criteria (COPD Cohort)

 24. Use of continuous (>16 hours/day) oxygen therapy

 25. Use of oxygen therapy during PSG

 26. Determination that, in the opinion of the investigator, removal of oxygen therapy
 could affect the participant's safety or interfere with the study assessments

 27. Recent changes to COPD medications or recent acute exacerbation of COPD (that is,
 needing hospitalization or treatment with oral corticosteroids and/or antibiotics)
 within 3 months of enrollment

 28. On screening spirometry (COPD only):

 -  FEV1/FVC >=0.70

 -  FEV1 >=80% predicted (GOLD 1 Classification for mild COPD)

 -  FEV1 <30% predicted (GOLD 4 Classification for very severe COPD)

 29. On screening PSG (COPD only):

 -  Moderate to severe OSA (AHI >=15)

 -  SpO2 <90% during wakefulness (supine and sitting)

 -  SpO2 during sleep <80% for 25% or more of the recording with >5 consecutive
 minutes <80% and any SpO2 reading <70%

 30. ECG evidence of right ventricular hypertrophy or right heart failure

 31. Screening hematocrit >55%

 32. Use of a CPAP device or dental appliance within 2 weeks of the screening PSG, and does
 not agree to abstain from the use of a CPAP device or dental appliance from the
 Screening Visit through the last study visit

 33. Current evidence of a clinically significant, active respiratory disorder other than
 COPD and mild OSA. This includes 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.

 34. Current evidence of other clinically significant disease other than COPD and mild OSA
 (example, 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.