Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients With Primary Insomnia
Brief Summary: This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.


Options:
A: Inclusion Criteria:

* Must be ≥18 yrs old on the day of signing informed consent
* Diagnosed with Primary Insomnia
* Good physical and mental health
* Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination
* A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
* Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
* Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
* Regular bedtime is between 9 pm-1 am
* Willing to refrain from napping while in study
* Able to read, understand and complete questionnaires and all diaries
* Willing to limit alcohol, caffeine, and nicotine consumption while in the study
* For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory

Exclusion Criteria:

* Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study
* History or diagnosis of another sleep disorder
* Difficulty sleeping due to a medical condition
* History of a neurological disorder
* History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
* Ongoing depression
* History of substance abuse or dependence
* History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit
* Taking certain prohibited medications
* Consumption of the equivalent of \>15 cigarettes a day
* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Participant is considered morbidly obese
* Previously randomized in another investigational study of suvorexant
B: Inclusion Criteria:

* Older than 60 years;
* Circadian cycle sleep disorder with insomnia (according to Diagnostic and Statistical Manual of Mental Disorders- V criteria);
* Mild or moderate dementia (clinical dementia rating 1 and 2);
* Medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks.

Exclusion Criteria:

* They had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.
C: Inclusion Criteria:

* Diagnosis of primary insomnia
* Participant is able to read, understand, and complete questionnaires and diaries
* If female, participant and partner both agree to use acceptable contraception. If male partner does not use an effective form of contraception, female participant must use 2 acceptable forms of contraception
* If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

* If female, participant is pregnant
* Participant expects to donate eggs or sperm during the study
* Recent and/or active history of a confounding neurological disorder
* History of clinically unstable cardiovascular disorder within the last 6 months
* Lifetime history of bipolar disorder
* Psychiatric condition that requires treatment with a medication prohibited by the study, or any other psychiatric condition that would interfere with the participant's ability to participate in the study
* History of substance abuse/dependence
* History of cancer ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive Symptomatology Self-Report 16-Item (\[QIDS-SR16\] suicide item #12)
* Participant has travelled across \>3 time zones or \>3 hour time difference in the last 2 weeks
* History of permanent night shift work or rotating day/night shift work in the past 2 weeks
* Body Mass Index (BMI) \>40 kg/m\^2
D: Inclusion Criteria:

* Fifty-five years of age or older;
* Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria;
* Hachinski Ischemia Scale score less than 5
* Mini-Mental State Examination score of O to 26
* Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week;
* For-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale;
* Sleep disturbance observed was not present before the diagnosis of AD;
* Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms;
* Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infarct in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal;
* Stable medications for 4 weeks prior to the screening visit;
* Having a mobile upper extremity to which to attach an actigraph;
* Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principal caregiver for the 3-week protocol;
* Ability to ingest oral medication and participate in all scheduled evaluations

Exclusion Criteria:

* Sleep disturbance associated with an acute illness, delirium or psychiatric disease;
* Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness
* Severe agitation;
* Unstable medical condition;
* Discontinuation of psychotropic or sleep medications within 2 weeks of the screening visit;
* Patient unwilling to maintain caffeine abstinence after 2:00 PM for the duration of the protocol;
* Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00 PM for the duration of the protocol;
* Prior use of trazodone for the treatment of sleep disturbances;
* Caregiver deemed too unreliable to supervise the wearing of the actigraph, to administer trazodone the proper time, to maintain tbe sleep diary, or to bring the patient to the scheduled visits;

Answer: C