Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Long Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
Brief Summary: A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.


Options:
A: Inclusion Criteria:

* • Diagnosis of insomnia based on DSM-IV criteria for insomnia due to a general medical condition (low-back pain);

  * The insomnia must not predate the onset of low-back pain by more than 1 month;
  * Usual nightly TST (Total Sleep Time) \< 6.5 hours and/or usual SOL (Sleep Onset Latency) \> 30 minutes for the last month prior to screening;
  * ISI (Insomnia Severity Index) \> 14 (at least moderate insomnia);
  * Age 21-64 years;
  * Greater than 40 on VAS (Visual Analog Scale) for pain (scale is 0-no pain to 100-worst imaginable pain);
  * Patient Global Impression of Pain of at least 3 (on a 1-5 scale, indicating at least moderate severity);
  * reported Back pain must be greater than reported leg pain, and there must be no signs of spinal nerve root compression;
  * presence of normal motor strength on exam;
  * duration of chronic low back pain of greater than three months;
  * low back pain location must be inferior to T12 and superior to the gluteal fold.

Exclusion Criteria:

* • Significant medical or neurological illness in excess of that which is directly responsible for the chronic low back pain;

  * the presence of an active and significant psychiatric disease with a substantive impact on sleep;
  * meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
  * current pregnancy; history of hypersensitivity, intolerance, or contraindication to Naproxen/Lansoprazole or Eszopiclone;
  * baseline creatinine of 2.0 or greater; patient taking other medications having significant renal effects (e.g. lithium, ACE inhibitor, angiotensin receptor antagonist, or thiazide/loop diuretics);
  * patients taking other anticoagulants; patients having an allergy to aspirin; history of diagnosed gastric or duodenal ulcer;
  * history of bleeding or clotting diathesis; lifetime history of myocardial infarction or cerebrovascular accident;
  * Elevated PT/PTT/INR (Prothrombin Time, Partial Thromboplastin Time, International Normalized Ratio)at screening;
  * Abnormal kidney function detected in screening labs;
  * history of back related surgery within the past 3 months; history of corticosteroid use in the past 30 days;
  * presence of currently pending litigation or worker's compensation claim related to the chronic low back pain;
  * inability to follow study procedures or complete the study; or the use of any medications that could affect sleep within 5 half-lives of screening;
  * history of back surgery within the past 2 years with the exception of a discectomy;
  * pregnant or lactating females;
  * women of child-bearing potential who will not agree to use approved means of birth control during the trial;
  * history of any surgery within the past one month; history of any major physical trauma within the last 6 months;
  * history of corticosteroid use within the last 90 days; diagnosis of rheumatoid or psoriatic arthritis;
  * history of fibromyalgia;
  * presence of spondyloarthropathy;
  * presence of sciatica;
  * spinal stenosis;
  * presence of any vertebral fractures, spondylolisthesis; or radicular back pain.
B: 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 25-64 years of age (inclusive) on the day of signing consent.
* Subject must be diagnosed with rheumatoid arthritis as defined by the American College of Rheumatology.
* Subject must be on stable regimen for treatment of rheumatoid arthritis for a minimum of 90 days prior to study start.
* Subject must report a wake time after sleep onset (WASO) of greater than or equal to 45 minutes and less than or equal to 6.5 hours of total sleep time at least three times a week over the previous month and symptoms of insomnia must post date onset of rheumatoid arthritis.
* Subject physical exam must show no clinically significant abnormal findings (other than those related to rheumatoid arthritis) at screening.
* Subject must have no clinically significant abnormal laboratory findings at screening (other than those related to rheumatoid arthritis).
* Subject must have no clinically significant ECG abnormalities at screening.

Exclusion Criteria

* Subject has diagnosis of fibromyalgia, or juvenile rheumatoid arthritis.
* 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 clinically significant unstable medical abnormality or unstable chronic disease (other than insomnia and rheumatoid arthritis) including severe cardiac, renal, or hepatic or respiratory disease, seizure disorder.
* Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in any investigational drug study during participation in this study.
* Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
* Subject has a current primary psychiatric diagnosis of any of the following disorders: dementia, delirium, schizophrenia, psychosis, other psychotic disorders, dysthymic disorder; major depressive disorder, bipolar disorders; cyclothymic disorder, other mood disorders, primary anxiety disorders, primary panic disorders, or any nocturnal panic disorder.
* Subject has any of the following Personality Disorders diagnoses: schizotypal, schizoid, borderline personality disorder; or any other personality disorder that would compromise the investigator's ability to evaluate the safety and efficacy of the study medication.
* Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis \[e.g. sleep apnea\]; diagnosed and untreated restless leg syndrome (RLS) or periodic leg movement syndrome (PLMS).
* 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.
C: 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.
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: C