Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause
Brief Summary: To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.


Options:
A: Inclusion Criteria:

1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
2. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

   * Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
3. Participants who meet both of the following based on polysomnogram (PSG) in observation period:

   * Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
   * Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

1. Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
3. Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
4. Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
5. Participants with organic mental disorder.
B: Inclusion Criteria:

* Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as defined by DSM-IV criteria with associated sleep disturbance

Exclusion Criteria:

* Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception.
* Concurrent use of other psychotropic medications, other than antidepressants at stable dose for at least 4 weeks prior to randomization
* Serious medical illness or instability
* Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
* Concurrent psychotherapy initiated within one month of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
* Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in the past 3 months, or dependence within the past 6 months.
* Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake
C: 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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D: Inclusion Criteria

* Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
* Subject must be between the ages of 40 and 60 years, inclusive, on the day of signing consent.
* Subject must have perimenopausal or menopausal signs and symptoms.
* Subject must report SL of \>45 minutes and \<6 hours of TST at least three times a week over the previous month and symptoms of insomnia must post date onset of perimenopausal or menopausal symptoms.
* Subject's physical exam must show no clinically significant abnormal findings (other than insomnia and menopause symptoms) at screening.

Exclusion Criteria

* Subject has history of circadian rhythm disorder, or travels across \>3 time zones on a regular basis.
* Female subject is pregnant, lactating or within 6-months post partum.
* Subject has a history of drug or alcohol abuse or dependence in the past 2 years or positive urine drug test at screening .
* Subject has unstable medical abnormality, or unstable chronic disease; or history of significant cardiac, renal, or hepatic disease, seizure disorder, or current or past acute suicidal tendencies.
* Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in another investigational drug study during participation in this study.
* Subject is taking hormone replacement therapy or an hormonal contraceptive, and has not been on a stable dose for a minimum of 60 days prior to study start.
* Subject is known to be seropositive for HIV.
* Subject has a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption distribution, metabolism, or excretion.
* Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
* Subject has a diagnosis of any psychiatric disorder as identified by a psychiatric screening questionnaire.
* Subject has any primary diagnosis (personality disorder or mental retardation) that would impact the investigator's ability to evaluate the safety or efficacy of the study medication.
* Subject has difficulties in sleep initiation or maintenance associated with other known primary sleep disorders \[e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS)\], or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.).
* Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
* Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
* Subject is a rotating or third/night shift worker.
* Subject is a staff member or relative of a staff member.
* Subject is experiencing symptoms of premature menopause or surgical menopause.
* Subject has discontinued hormone replacement therapy or a hormonal contraceptive, and has not been off treatment for a minimum of 60 days prior to study start.
* Subject has been on hormone replacement therapy or hormonal contraceptives for greater then one year.

Answer: D