Study of the Insomnia in Patients With Low Back Pain

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.