Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
Brief Summary: The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.


Options:
A: Inclusion criteria:

1. Participants who submit written informed consent for study entry.
2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).
4. Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:

   * Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
   * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
5. Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:

   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
   * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

Exclusion criteria:

1. Participants with a present or history of the following disease specified in

   Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:
   * Risk of suicide
   * (Mild) manic episode
   * Post-traumatic stress disorder (PTSD)
   * Alcohol dependence and abuse
   * Drug (non-alcohol) dependence and abuse
   * Anorexia nervosa
   * Bulimia nervosa
   * Anti-social personality disorder
2. Participants with pharmacologically induced insomnia (drug-induced insomnia).
3. Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.
4. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
5. Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
6. Participants with organic mental disorder.
B: Inclusion Criteria:

* Chronic insomnia defined as a) sleep onset latency and/or wake after sleep onset longer than 30 minutes per night, at least 3 nights per week; and b) Insomnia duration of at least 6 months, by self-report; and c) minimum of 1 daytime complaint by self-report (e.g. fatigue, mood disturbance);
* Between 18 and 65 years of age;
* English-speaking;
* Literate;
* Mentally intact;
* Interested in either medication or mind-body interventions;
* Able to attend weekly classes in a Minnesota Metro area;
* Able to comply with study sleep monitoring requirements;
* Willing to complete the informed consent process.

Exclusion Criteria:

* Sleep apnea or other primary sleep disorder suspected of being responsible for insomnia;
* Mental disorder or substance (including medications) suspected of being responsible for insomnia;
* General medical condition suspected of being responsible for the insomnia;
* Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major surgery planned in the next 3 months);
* Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse;
* Treatment for depression or anxiety with initiation of therapy or dosage change within the last 6 months;
* Use of non-prescription sleep aids and unwilling or unable to discontinue these during the study;
* Use of prescription sleep medications or other medications known to affect sleep or be contraindicated with use of hypnotics, and unwilling or unable to discontinue these during the study;
* Known allergy to eszopiclone;
* Shift worker;
* Pregnant , breast-feeding or planning pregnancy in next 6 months;
* Previous cognitive behavioral therapy for insomnia or current psychotherapy;
* Prior MBSR class or regularly practicing mindfulness meditation.
C: Inclusion Criteria:

* Score of greater than 10 on the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (PRIME-MD-PHQ) telephone screen
* Diagnosis of major depressive episode based on the Structured Clinical Interview for DSM-IV (SCID)
* Score of greater than 20 on the Hamilton Rating Scale for Depression
* Meets research diagnostic criteria for insomnia disorder at least 4 nights per week
* Reported mean sleep latency greater than 30 minutes and mean sleep efficiency less than 85%
* Suitable for outpatient treatment

Exclusion Criteria:

* Use of any psychotropic medications within 2 weeks of initial screening
* Bipolar disorder, schizophrenia, psychotic depression, or any other psychotic disorder
* Uncontrolled asthma or chronic obstructive pulmonary disease
* Chronic pain that may be a significant sleep-disturbing factor
* Uncontrolled thyroid disease
* Poorly controlled diabetes mellitus
* Poorly compensated congestive heart failure
* Currently taking lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep
* History of intolerance or treatment resistance to either fluoxetine or eszopiclone
* Inability to abstain from taking any psychotropics other than the study medications during the course of the protocol, including sedating antihistamines
* Use of any herbal or naturopathic treatments for sleep or mood (i.e., St. John's wort, melatonin, kava kava, valerian root, etc.)
* Currently undergoing behavioral, cognitive-behavioral, or interpersonal therapy
* Pregnant or breastfeeding
* Agrees to use an effective form of contraception for the duration of the study
* Uncontrolled symptoms of menopause, including hot flashes
* Uncontrolled hypertension (systolic blood pressure consistently greater than 140 mm Hg, diastolic blood pressure consistently greater than 90 mm Hg)
* Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome
* Reports habitual bedtime earlier than 9 PM or later than 1 AM more than 2 times per week
* Reports habitual rising time later than 9 AM more than 2 times per week
* Body mass index greater than 30
* Consumes more than 3 alcoholic beverages per day
* Consumes more than 4 caffeinated beverages per day
* Habitual smoking between 11 PM and 7 AM
* Use of illicit drugs
* Score greater than 24 on the Mini Mental State Examination
* Determined to be incompetent
* Determined to be at imminent risk for suicide
* More than 5 lifetime SCID diagnoses of major depressive episodes
* More than 3 failed antidepressant trials during the current episode of depression, as determined by the Antidepressant Treatment History Form
* A course of electroconvulsive therapy during the present depressive episode
D: 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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Answer: A