Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia
Brief Summary: To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.


Options:
A: Inclusion Criteria:

Inclusion Criteria:

* Subject is male or female 6 17 years of age, inclusive, at the time of consent.
* Subject must have a diagnosis of ADHD as defined by DSM-IV criteria • The diagnosis for Rollover subjects will be taken from the Screening visit of Study 190 246. Treatment naïve subjects will have these assessments performed at the Screening visit.
* 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 has either \>30 minutes latency to persistent sleep (LPS) or \>45 minutes wake time after sleep onset (WASO) demonstrated by PSG.
* 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 at screening
* Subject must be in good general health.
* Subject must be able to swallow tablets.
* If subjects are currently taking medication for ADHD, they must be on a stable dose and regimen for at least one month, and preferably for at least 3 months 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 abnormality/illness
* Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, as determined by medical or psychiatric history or as determined by clinical interview using the MINI-Kid at Visit 1.
* Subject has periodic limb movement \>5 times per hour, as demonstrated on PSG.
* Subject has sleep disordered breathing, as demonstrated on PSG.
* Subject has another primary sleep disorder (or secondary sleep disorder that is causing clinical impairment 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, lactating or planning to become pregnant.
* Subject is taking any psychotropic or disallowed medications,
* 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
* Subject has participated in any investigational study within 30 days prior to study entry or is currently participating in another clinical trial, except Study 190 246.
B: Inclusion Criteria:

* Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.

Exclusion Criteria:

* Subject has recent history of known clinically significant abnormal laboratory findings.
C: 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
D: 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.

Answer: B