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A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.
Objectives: Chronic pain is associated with insomnia. The objective of this clinical study is to compare the efficacy and safety of different prescribed doses of Zopiclone and Clonidine; for the management of insomnia in patients with chronic pain.
Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 was considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine vs Zopiclone for insomnia | Consecutive adult patients who underwent pain management at a Canadian pain clinic. The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose). They were advised to take either clonidine or zopiclone on alternate nights. For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations. The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1. The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg. Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks. Therefore, each of the four medication doses was used five times by each patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine 0.1mg pill | Drug | Routine prescription for insomnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality score, objective measurement using the validated Likert sleep scale | Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score, objective measurement using the validated Numeric Pain Rating scale | Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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A cohort of consecutive adult patients who underwent pain management at a Canadian pain clinic
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| Name | Affiliation | Role |
|---|---|---|
| Olu Bamgbade, MD, FRCPC | Salem Anaesthesia Pain Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salem Anaesthesia Pain Clinic | Surrey | British Columbia | V3S 7J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9112585 | Background | Lader M. Zopiclone: is there any dependence and abuse potential? J Neurol. 1997 Apr;244(4 Suppl 1):S18-22. doi: 10.1007/BF03160567. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D013607 | Tablets |
| C515050 | zopiclone |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Clonidine 0.2mg pill | Drug | Routine prescription for insomnia |
|
|
| Zopiclone 3.75mg pill | Drug | Routine prescription for insomnia |
|
|
| Zopiclone 7.5mg pill | Drug | Routine prescription for insomnia |
|
|
| D001523 |
| Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |