CALPXT96A Phase 3 Double Blind, Randomized, Placebo Controlled, Cross-Over Trial to Asses the Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain

Study Design: This will be an 'n of 1' model, with the patient acting as their own control. To identify any possible negative 'wash out' effect after cessation of the active medication (that could negatively impact the 'no drug' arm) we have to do the following. After baseline documentation with standardized scales, randomize to one of 2 arms: 1. Arm A * 1st treatment period: 4 weeks active drug (two capsules of CALPXT96 hs) * 2 week wash out period * 2nd treatment period: 4 weeks placebo (two capsules of CALPXT96 hs) 2. Arm B * 1st treatment period: 4 weeks placebo (two capsules of CALPXT96 hs) * 2 week ash out period * -2nd treatment period: 4 weeks active drug (two capsules of CALPXT96 hs) Objectives: Primary objective The primary objective of this study is: * Does nightly use of CALPXT96 improve sleep in patients with CNCP? Secondary objective * The secondary objective of this study are: * Does CALPXT96 improve functionality as defined by the PDI (or Short-Form Health Survey-12 (SF12))? * Does CALPXT96 decrease pain levels (average, highest, lowest) (Brief Pain Inventory)? * Does CALPXT96 allow for a decrease in other medications prescribed for pain? Efficacy Measures * Changes in quality of seep as measured by the the Pittsburgh Sleep Quality Index (PSQI) and the Pain and Sleep Questionnaire (PSQ-3). * Changes in pain intensity scores (Brief Pain Inventory) and changes in functionality and health related quality of life as measured with the Pain Disability Index (PDI) and SF-12v2 respectively. Population: Chronic pain patients suffering from CNCP for greater than 1 year, with complaint of poor sleep (defined as >/= 5 on the Pittsburgh Sleep Quality Index (PSQI), aged 18 and up and of a normal mix of gender, age, and socioeconomic status and with a stable pain management treatment for at least one month. Inclusion Criteria Subjects are eligible to be included in the study only if they meet all of the following criteria: 1. Age > 17 and < 75 2. Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. (Validated tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a suitable cut points (PSQI >/=5) to ensure greater homogeneity of the sample and the recruitment of only those with significant pain related sleep disturbance.) 3. Stable pain management therapy for 1 month prior to entry into the study 4. Having a confirmed diagnosis of CNCP for greater than 1 year 5. Written informed consent obtained. 6. Subject agreed to follow the protocol. Exclusion Criteria Subjects will be excluded from the study if they meet any of the following criteria: 1. Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they are willing to cease any current hypnotic for at least 2 weeks prior to commencing the study 2. Current alcohol abuse or other addiction 3. Sleep apnea disorder 4. Inability to understand and comply with the instructions of the study 5. Previous enrollment in the study 6. Renal and/or liver insufficiency 7. Patients less than age 18 8. Pregnancy or lactation 9. Current (</=one year) Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnosis of major depressive disorder, dysthymia, generalized anxiety disorder and DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by patient history