Primary Insomnia
Conditions
Keywords
Insomnia, Low Back Pain, Hypnotics, Eszopiclone, Pain, Disability
Brief summary
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
Detailed description
There is a great need to develop effective treatments for insomnia in patients with chronic low-back pain. Chronic low-back pain is among the most prevalent of all health complaints, is associated with enormous health-care and productivity costs, reduced quality of life, and limitation of function and is almost universally associated with insomnia (Rives and Douglas, 2004). While it had long been believed that insomnia was a symptom of pain conditions and of little consequence in its' own right, a growing literature suggests that insomnia has important effects on the clinical course of pain syndromes (Smith and Haythornthwaite, 2004). While pain may disrupt sleep, it appears that problems with sleep increase pain and are associated with impairments in daytime function. The emerging point of view is that specific treatment for both pain and insomnia is needed for optimal clinical management (Smith and Haythornthwaite, 2004). Surprisingly, despite the fact that chronic low-back pain is the most common pain condition, the treatment of insomnia in this disease has never been studied. As a result, we propose to carry out the first double-blind placebo-controlled study of the treatment insomnia in patients with chronic low back pain. Comparison(s): We will test the hypothesis that treating the insomnia with eszopiclone 3 mg (ESZ) along with management of pain with naproxen 500 mg bid (NAP) will result in statistically significantly improved sleep compared with placebo. We also propose to test as a secondary hypothesis that treatment with ESZ will lead to significant improvement in pain and daytime function vs. placebo.
Interventions
DRUGEszopiclone
Eszopiclone 3 mg po nightly for duration of study blind phase.
DRUGPlacebo
Placebo nightly over duration of double blind study phase
Sponsors
Sumitomo Pharma America, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | Postnaprosyn baseline, Week 1, week 2, week 4 | Nightly total sleep time was averaged from diary entries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sleep Onset Latency (SOL) | Postnaprosyn Baseline, Week 1, Week 2 week 4 | — |
| Wake Time After Sleep Onset | Postnaprosyn Baseline, Week 1, Week 2 week 4 | — |
| Number of Awakenings | Postnaprosyn Baseline, Week 1, Week 2 week 4 | — |
| Sleep Quality Ratings | Postnaprosyn Baseline, Week 1, Week 2 week 4 | Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep |
| Insomnia Severity Index (ISI) | Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4 | The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). |
| Visual Analog Scale Pain Ratings (VAS) | Postnaprosyn baseline, Week 1, Week 2, Week 4 | Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain |
| Roland Morris Low Back Pain Inventory (RMLBPI) | prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4 | The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 yes-no items assessing potential disabilities. Scores range from 0 (no disability) to 24 (severe disability). |
| Hamilton Depression Rating Scale (HAM-D-24) | prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4 | The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. |
| Short Form 36 Health Survey Questionnaire (SF-36) | Baseline, week 1, week 2, week 4 | The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best). |
| State-Trait Anxiety Inventory (STAI) | Baseline, week 1, week 2, week 4 | Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement) |
| Patient Global Impression of Pain Ratings | postnaprosyn Baseline, Week 1, Week 2 week 4 | Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain) |
Countries
United States
Participant flow
Recruitment details
Seventy adult volunteers with low back pain who met diagnostic criteria for insomnia were recruited through newspaper advertisements, posted announcements and physician referrals. Of those 70, 10 did not meet inclusion criteria, and 2 chose not to participate. The remaining 58 were randomized.
Pre-assignment details
Qualifying subjects were switched from their current pain regimen to naproxen and lansoprazole. We excluded those with: significant medical or neurological illness other than LBP; psychiatric disease impacting sleep; substance abuse; history of hypersensitivity or contraindication to NAP/LAN or ESZ; abnormalities on baseline laboratory tests.
Participants by arm
| Arm | Count |
|---|---|
| Eszopiclone Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase. | 33 |
| Placebo Placebo : Placebo nightly over duration of double blind study phase. | 25 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Placebo | Eszopiclone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 33 Participants | 58 Participants |
| Age, Continuous | 40.1 years STANDARD_DEVIATION 12.8 | 45.7 years STANDARD_DEVIATION 11 | 43.5 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment United States | 25 participants | 33 participants | 58 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 25 |
| serious Total, serious adverse events | 0 / 33 | 0 / 25 |
Outcome results
Primary
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
Nightly total sleep time was averaged from diary entries.
Time frame: Postnaprosyn baseline, Week 1, week 2, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | postnaprosyn baseline | 316.96 Minutes | Standard Deviation 91.55 |
| Eszopiclone | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | week 1 | 403.47 Minutes | Standard Deviation 77.67 |
| Eszopiclone | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | week 2 | 421.97 Minutes | Standard Deviation 68.28 |
| Eszopiclone | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | Week 4 | 411.97 Minutes | Standard Deviation 66.87 |
| Placebo | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | Week 4 | 388.96 Minutes | Standard Deviation 99.02 |
| Placebo | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | postnaprosyn baseline | 380.45 Minutes | Standard Deviation 81.33 |
| Placebo | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | week 2 | 382.11 Minutes | Standard Deviation 96.13 |
| Placebo | Mean Subjective Sleep Diary Derived Total Sleep Time (TST) | week 1 | 375.56 Minutes | Standard Deviation 88.74 |
Secondary
Hamilton Depression Rating Scale (HAM-D-24)
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Time frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Hamilton Depression Rating Scale (HAM-D-24) | postnaprosyn Baseline | 6.38 units on a scale | Standard Deviation 2.37 |
| Eszopiclone | Hamilton Depression Rating Scale (HAM-D-24) | Week 2 | 4.14 units on a scale | Standard Deviation 3.5 |
| Eszopiclone | Hamilton Depression Rating Scale (HAM-D-24) | Week 1 | 4.54 units on a scale | Standard Deviation 3.71 |
| Eszopiclone | Hamilton Depression Rating Scale (HAM-D-24) | Week 4 | 2.62 units on a scale | Standard Deviation 2.61 |
| Eszopiclone | Hamilton Depression Rating Scale (HAM-D-24) | prenaprosyn Baseline | 6.45 units on a scale | Standard Deviation 2.26 |
| Placebo | Hamilton Depression Rating Scale (HAM-D-24) | Week 4 | 6.21 units on a scale | Standard Deviation 5.18 |
| Placebo | Hamilton Depression Rating Scale (HAM-D-24) | prenaprosyn Baseline | 7.10 units on a scale | Standard Deviation 3.83 |
| Placebo | Hamilton Depression Rating Scale (HAM-D-24) | postnaprosyn Baseline | 6.57 units on a scale | Standard Deviation 3.63 |
| Placebo | Hamilton Depression Rating Scale (HAM-D-24) | Week 1 | 5.53 units on a scale | Standard Deviation 3.28 |
| Placebo | Hamilton Depression Rating Scale (HAM-D-24) | Week 2 | 5.07 units on a scale | Standard Deviation 3.61 |
Secondary
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia).
Time frame: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Insomnia Severity Index (ISI) | Postnaprosyn baseline | 18.00 units on a scale | Standard Deviation 3.41 |
| Eszopiclone | Insomnia Severity Index (ISI) | Week 2 | 10.61 units on a scale | Standard Deviation 6.6 |
| Eszopiclone | Insomnia Severity Index (ISI) | Week 1 | 11.28 units on a scale | Standard Deviation 6.1 |
| Eszopiclone | Insomnia Severity Index (ISI) | Week 4 | 8.38 units on a scale | Standard Deviation 6.42 |
| Eszopiclone | Insomnia Severity Index (ISI) | Prenaprosyn Baseline | 18.85 units on a scale | Standard Deviation 4.01 |
| Placebo | Insomnia Severity Index (ISI) | Week 4 | 13.75 units on a scale | Standard Deviation 6.78 |
| Placebo | Insomnia Severity Index (ISI) | Prenaprosyn Baseline | 20.26 units on a scale | Standard Deviation 4.07 |
| Placebo | Insomnia Severity Index (ISI) | Postnaprosyn baseline | 16.78 units on a scale | Standard Deviation 4.32 |
| Placebo | Insomnia Severity Index (ISI) | Week 1 | 12.85 units on a scale | Standard Deviation 5.97 |
| Placebo | Insomnia Severity Index (ISI) | Week 2 | 12.74 units on a scale | Standard Deviation 6.39 |
Secondary
Mean Sleep Onset Latency (SOL)
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Mean Sleep Onset Latency (SOL) | Postnaprosyn Baseline | 38.28 minutes | Standard Deviation 23.9 |
| Eszopiclone | Mean Sleep Onset Latency (SOL) | Week 1 | 22.36 minutes | Standard Deviation 16.59 |
| Eszopiclone | Mean Sleep Onset Latency (SOL) | Week 2 | 17.50 minutes | Standard Deviation 12.33 |
| Eszopiclone | Mean Sleep Onset Latency (SOL) | Week 4 | 15.28 minutes | Standard Deviation 12.95 |
| Placebo | Mean Sleep Onset Latency (SOL) | Week 4 | 19.91 minutes | Standard Deviation 12.3 |
| Placebo | Mean Sleep Onset Latency (SOL) | Postnaprosyn Baseline | 34.11 minutes | Standard Deviation 25.93 |
| Placebo | Mean Sleep Onset Latency (SOL) | Week 2 | 23.10 minutes | Standard Deviation 19.68 |
| Placebo | Mean Sleep Onset Latency (SOL) | Week 1 | 27.00 minutes | Standard Deviation 18.28 |
Secondary
Number of Awakenings
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Number of Awakenings | Week 2 | 1.35 awakenings | Standard Deviation 0.99 |
| Eszopiclone | Number of Awakenings | Week 1 | 1.31 awakenings | Standard Deviation 1.02 |
| Eszopiclone | Number of Awakenings | Week 4 | 1.33 awakenings | Standard Deviation 1.01 |
| Eszopiclone | Number of Awakenings | Postnaprosyn Baseline | 2.29 awakenings | Standard Deviation 1.48 |
| Placebo | Number of Awakenings | Week 4 | 2.34 awakenings | Standard Deviation 1.79 |
| Placebo | Number of Awakenings | Week 2 | 2.13 awakenings | Standard Deviation 1.81 |
| Placebo | Number of Awakenings | Postnaprosyn Baseline | 2.08 awakenings | Standard Deviation 1.51 |
| Placebo | Number of Awakenings | Week 1 | 1.98 awakenings | Standard Deviation 1.43 |
Secondary
Patient Global Impression of Pain Ratings
Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)
Time frame: postnaprosyn Baseline, Week 1, Week 2 week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Patient Global Impression of Pain Ratings | postnaprosyn Baseline | 4.02 units on a scale | Standard Deviation 0.95 |
| Eszopiclone | Patient Global Impression of Pain Ratings | Week 1 | 3.54 units on a scale | Standard Deviation 1.17 |
| Eszopiclone | Patient Global Impression of Pain Ratings | Week 2 | 3.30 units on a scale | Standard Deviation 1.27 |
| Eszopiclone | Patient Global Impression of Pain Ratings | Week 4 | 3.08 units on a scale | Standard Deviation 1.28 |
| Placebo | Patient Global Impression of Pain Ratings | Week 4 | 3.80 units on a scale | Standard Deviation 1.14 |
| Placebo | Patient Global Impression of Pain Ratings | postnaprosyn Baseline | 3.90 units on a scale | Standard Deviation 1.47 |
| Placebo | Patient Global Impression of Pain Ratings | Week 2 | 4.01 units on a scale | Standard Deviation 1.12 |
| Placebo | Patient Global Impression of Pain Ratings | Week 1 | 3.82 units on a scale | Standard Deviation 1.45 |
Secondary
Roland Morris Low Back Pain Inventory (RMLBPI)
The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 yes-no items assessing potential disabilities. Scores range from 0 (no disability) to 24 (severe disability).
Time frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Roland Morris Low Back Pain Inventory (RMLBPI) | Week 4 | 6.59 units on a scale | Standard Deviation 5.49 |
| Eszopiclone | Roland Morris Low Back Pain Inventory (RMLBPI) | prenaprosyn Baseline | 12.27 units on a scale | Standard Deviation 5.7 |
| Eszopiclone | Roland Morris Low Back Pain Inventory (RMLBPI) | postnaprosyn Baseline | 9.97 units on a scale | Standard Deviation 5.55 |
| Eszopiclone | Roland Morris Low Back Pain Inventory (RMLBPI) | Week 1 | 9.10 units on a scale | Standard Deviation 6.37 |
| Eszopiclone | Roland Morris Low Back Pain Inventory (RMLBPI) | Week 2 | 7.63 units on a scale | Standard Deviation 6.34 |
| Placebo | Roland Morris Low Back Pain Inventory (RMLBPI) | Week 2 | 9.32 units on a scale | Standard Deviation 6.25 |
| Placebo | Roland Morris Low Back Pain Inventory (RMLBPI) | Week 1 | 9.05 units on a scale | Standard Deviation 6.32 |
| Placebo | Roland Morris Low Back Pain Inventory (RMLBPI) | prenaprosyn Baseline | 11.33 units on a scale | Standard Deviation 5.66 |
| Placebo | Roland Morris Low Back Pain Inventory (RMLBPI) | Week 4 | 7.94 units on a scale | Standard Deviation 6.99 |
| Placebo | Roland Morris Low Back Pain Inventory (RMLBPI) | postnaprosyn Baseline | 10.30 units on a scale | Standard Deviation 5.75 |
Secondary
Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Time frame: Baseline, week 1, week 2, week 4
Population: Data not collected.
Secondary
Sleep Quality Ratings
Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Sleep Quality Ratings | Postnaprosyn Baseline | 4.52 units on a scale | Standard Deviation 1.45 |
| Eszopiclone | Sleep Quality Ratings | Week 1 | 5.99 units on a scale | Standard Deviation 1.43 |
| Eszopiclone | Sleep Quality Ratings | Week 2 | 6.18 units on a scale | Standard Deviation 1.45 |
| Eszopiclone | Sleep Quality Ratings | Week 4 | 6.38 units on a scale | Standard Deviation 1.66 |
| Placebo | Sleep Quality Ratings | Week 4 | 5.29 units on a scale | Standard Deviation 2 |
| Placebo | Sleep Quality Ratings | Postnaprosyn Baseline | 4.44 units on a scale | Standard Deviation 1.66 |
| Placebo | Sleep Quality Ratings | Week 2 | 5.33 units on a scale | Standard Deviation 1.77 |
| Placebo | Sleep Quality Ratings | Week 1 | 4.90 units on a scale | Standard Deviation 1.83 |
Secondary
State-Trait Anxiety Inventory (STAI)
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)
Time frame: Baseline, week 1, week 2, week 4
Population: Data not collected.
Secondary
Visual Analog Scale Pain Ratings (VAS)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Time frame: Postnaprosyn baseline, Week 1, Week 2, Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Visual Analog Scale Pain Ratings (VAS) | Postnaprosyn Baseline | 48.51 units on a scale | Standard Deviation 16.22 |
| Eszopiclone | Visual Analog Scale Pain Ratings (VAS) | Week 1 | 40.72 units on a scale | Standard Deviation 17.13 |
| Eszopiclone | Visual Analog Scale Pain Ratings (VAS) | Week 2 | 34.70 units on a scale | Standard Deviation 18.49 |
| Eszopiclone | Visual Analog Scale Pain Ratings (VAS) | Week 4 | 31.69 units on a scale | Standard Deviation 17.92 |
| Placebo | Visual Analog Scale Pain Ratings (VAS) | Week 4 | 51.60 units on a scale | Standard Deviation 22.44 |
| Placebo | Visual Analog Scale Pain Ratings (VAS) | Postnaprosyn Baseline | 53.79 units on a scale | Standard Deviation 20.96 |
| Placebo | Visual Analog Scale Pain Ratings (VAS) | Week 2 | 51.25 units on a scale | Standard Deviation 19.61 |
| Placebo | Visual Analog Scale Pain Ratings (VAS) | Week 1 | 51.99 units on a scale | Standard Deviation 20.83 |
Secondary
Wake Time After Sleep Onset
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eszopiclone | Wake Time After Sleep Onset | Postnaprosyn Baseline | 91.51 minutes | Standard Deviation 55.91 |
| Eszopiclone | Wake Time After Sleep Onset | Week 1 | 49.34 minutes | Standard Deviation 32.62 |
| Eszopiclone | Wake Time After Sleep Onset | Week 2 | 37.07 minutes | Standard Deviation 22.21 |
| Eszopiclone | Wake Time After Sleep Onset | Week 4 | 36.74 minutes | Standard Deviation 28.44 |
| Placebo | Wake Time After Sleep Onset | Week 4 | 76.18 minutes | Standard Deviation 65.5 |
| Placebo | Wake Time After Sleep Onset | Postnaprosyn Baseline | 81.43 minutes | Standard Deviation 54.58 |
| Placebo | Wake Time After Sleep Onset | Week 2 | 81.32 minutes | Standard Deviation 76.3 |
| Placebo | Wake Time After Sleep Onset | Week 1 | 76.71 minutes | Standard Deviation 65.84 |