Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032)

Inclusion Criteria

• Female participants of reproductive potential must demonstrate a serum beta-human chorionic gonadotropin (β-hCG) level consistent with the nongravid state at the prestudy (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study (including washout intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Females of non-childbearing potential (postmenopausal without menses for at least 1 year and follicle stimulating hormone [FSH] value in the postmenopausal range, or status post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy)
• Body Mass Index (BMI) ≤40 kg/m2 at the prestudy (screening)
• COPD documented by medical history and pulmonary function tests with spirometry measurements at Visit 1 meet all of the following COPD study criteria according to the modified Global Initiative for Obstructive Lung Disease (GOLD) criteria (forced expiratory volume [FEV1]/ forced vital capacity [FVC] ratio ≤70% and FEV1 ≥40% predicted [inclusive])
• Stable physical health for at least 2 weeks prior to entering the study
• No clinically significant abnormality on electrocardiogram (ECG)
• No clinically significant abnormality on the screening polysomnography (PSG) including no evidence of obstructive sleep apnea, restless leg syndrome, periodic limb movement disorder, parasomnia including nightmare disorder, sleep terror disorder and sleepwalking disorder but participants with insomnia may be enrolled
• Nonsmoker or smokes ≤20 cigarettes or equivalent per day without the urge to wake up to smoke during the night
• Sleeps for 4 hours or more per night with a usual bedtime between 8:00 post meridian (PM) and 12:30 ante meridian (AM)
• Participant must complete a sleep diary for at least 5 consecutive days and up to 21 days prior to the screening PSG visit
• Participant is reliably able to perform the study assessments; demonstrates ability to understand task instructions, and is physically capable

Exclusion Criteria

• Participant is mentally or legally incapacitated, has significant emotional problems at the time of prestudy or expected during conduct of the study, or has a history or evidence of a clinically significant psychiatric disorder that would interfere with participation in the study
• Abnormal pre-randomization laboratory values in alanine transaminase (ALT >1.5 x the upper limit of normal [ULN]), aspartate transaminase (AST >1.5 x ULN), total bilirubin >1.5 x ULN, and serum creatinine of >2 mg/dL
• Participant has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness within the last 10 years
• History of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder, or psychiatric condition requiring treatment with a prohibited medication, or psychiatric condition that, in the investigator's opinion, would interfere with the patient's ability to participate in the study
• Participant has other than COPD and evidence of another clinically significant, active pulmonary disorder, such as such as bronchiectasis or asthma documented by history, physical examination, or chest x-ray
• History within the past 6 months prior to the prestudy of acute coronary syndrome, unstable angina, congestive heart failure, cardiogenic syncope, cardiomyopathy, any symptomatic arrhythmia, orthostatic hypotension, or uncontrolled hypertension
• History of neoplastic disease except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, malignancies which have been successfully treated ≥10 years prior to the prestudy and follow-up has revealed no evidence