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) 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.