Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Randomized, Placebo Controlled Trial Assessing the Effects of Ezopiclone on the Quality of Overnight Polysomnography and CPAP Titration
Brief Summary: Patients often have difficulty sleeping during overnight sleep testing in a lab environment. The purpose of this study is to determine if taking a sleep aid will improve sleep and therefore the quality of the sleep study.


Options:
A: Inclusion Criteria:

1. Parkinson's disease by research criteria. Research criteria for PD include, (1) the presence of at least 2 of the following signs: resting tremor, cogwheel rigidity, bradykinesia, or postural reflex impairment, at least 1 of which must be either resting tremor or bradykinesia, (2) no other cause of parkinsonism, (3) no signs of more extensive neurodegeneration indicating atypical parkinsonism, and (4) a clear-cut response to levodopa or dopamine agonist.
2. Sleep maintenance insomnia (at least 3 of 7 nights of at least 2 awakenings nightly, or a total sleep time of \< 6.5 hours) or sleep latency insomnia (at least 3 of 7 nights of sleep latency \> 30 minutes), as well as clinically significant daytime distress or impairment during the 2 week self assessment prior to baseline.
3. Patients aged 35-85 years.
4. Patients must have completed at least the 9th grade and be fluent in English.
5. If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Patients must have a negative urine pregnancy test at the screen visit.
6. Antidepressants will be allowed if the patient has been on a stable dose for at least one month.
7. Benzodiazepines will be allowed if taken during the day prior to 6pm and it is not taken as a sleep aid.
8. Other medications with CNS activity that the patient is on at screening, e.g., dopaminergic drugs, B-blockers, etc, will be kept constant throughout the acute phase.

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Exclusion Criteria:

1. Evidence on PSG and symptoms or complaints (as defined below) of, significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder (PLMD), or REM sleep behavior disorder (RBD).
2. Significant sleep disordered breathing will be defined as an AHI \> 15 events/hr of sleep and/or significant hypoxemia on screening PSG; significant PLMD will be defined as a PLM index \> 25 events/hr of sleep on screening PSG; RBD will be defined based on presence of both clinical symptomatology (demonstrated injury to self or others during sleep) as well as PSG criteria (intermittent loss of REM atonia).
3. No significant dementia. Significant dementia is operationalized as a score of less than 26 on the Mini-Mental State Examination (MMSE).
4. Insomnia is not primarily due to serious depression or anxiety in the opinion of the investigator.
5. Any current (within three months) diagnosis of alcohol or substance abuse/dependence (with the exception of nicotine dependence).
6. Currently on psychotropic medications, other than antidepressants or benzodiazepines. If the patient is on other psychotropics, and can be safely removed from these medications at the time of initial screening, there will be a washout period prior to entering the study.
7. Sleep medication that the patient is on during screening will be tapered prior to randomization.
8. Any unstable medical disorder that would interfere with the study.
9. Patients with a known history of non-response or lack of toleration to adequate doses of zolpidem or trazodone.
10. Patients currently receiving CBT for insomnia.
11. Patients who are unable to be maintained on their current dose of PD medications throughout the trial.

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B: Inclusion Criteria:

* Sign the informed consent form for the study;
* Be ≥ 20 to ≥ 64 years old;
* Have diagnosis of symptomatic primary insomnia for at least 3 months;
* Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
* Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).

Exclusion Criteria:

* Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
* Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
* Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
* Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
* History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
* History of substance abuse or dependence;
* Patients with severe co-morbidities (at the investigator's opinion);
* Presence of liver disorders, cirrhosis or liver failure;
* Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;
* Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.
C: Inclusion Criteria:

* All adult patients aged 18-65, evaluated by a sleep medicine provider in the Walter Reed Army Medical Center Sleep Disorders Clinic, who are referred for PSG for suspected Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

* Pregnancy
* Liver dysfunction or history of EtOH abuse
* Concomitant use of benzodiazepines, narcotics or ketozonazole
* Decompensated CHF
* CVA within 3 months
* Uncontrolled psychiatric disorders
* Patients \< 18 years old
* Patients over 65
D: Inclusion Criteria:

* Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.
* Subject must have a diagnosis of ADHD as defined by DSM-IV criteria
* Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency \>30 minutes) or consolidation, (wake time after sleep onset \>45 minutes) despite adequate age appropriate time and opportunity for sleep.
* Subject's Baseline PSG must reveal either \>30 minutes latency to persistent sleep (LPS) or \>45 minutes wake after sleep onset (WASO).
* Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
* Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time
* Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)
* Subject must be in general good health
* Subject must be able to swallow tablets.
* If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent

Exclusion Criteria:

* Subject with weight \<10th percentile for age and gender
* Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.
* Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.
* Subject has periodic limb movement \>5 times per hour, as demonstrated on Baseline PSG.
* Subject has sleep disordered breathing, as demonstrated on Baseline PSG.
* Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
* Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
* Subject has organic brain disease, or a history of febrile seizures.
* Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
* Female subject who is pregnant or lactating or planning to become pregnant.
* Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.
* Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
* Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
* Subject has a history of alcohol or substance abuse within 3 months of study participation.

Answer: C