Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Eligibility criteria:
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.