McGill University Health Center [provisional name] (Nabilone for fibromyalgia [provisional name])
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Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

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Registry of Trials clinicaltrials.gov
Year 2006
Links Registry of Trials

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms. The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.

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The effects of nabilone on insomnia in fibromyalgia: results of a randomized controlled trial

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Conference American College of Rheumatology/Association of Rheumatology Health Professionals Annual Scientific Meeting. Published in: Arthritis Rheum. 2009;60:1429
Year 2009

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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The effects of nabilone on sleep in fibromyalgia: Results of a randomized controlled trial

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Conference Canadian Rheumatology Association Meeting, 2009; Kananaskis, AB: Canada
Year 2009
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This article is included in 1 Systematic review Systematic reviews (1 reference)

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Objective: Fibromyalgia (FM) is a chronic pain syndrome associated with dysregulation of central nervous system pain processing. Insomnia affects over 75% of patients, and tricyclic antidepressants are the mainstay of treatment. Cannabis is used by some patients with FM to help sleep. We evaluated the safety and efficacy of nabilone, a synthetic cannabinoid, on sleep disturbance in FM. Methods: We conducted a randomized double-blind active control equivalency crossover trial to compare nabilone (0.5-1.0mg before bedtime) to amitriptyline (10-20mg before bedtime) in FM patients with chronic insomnia. Subjects received each drug for two weeks with a two-week washout period. The primary outcome was sleep quality, measured by the Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ). Secondary outcomes included pain, mood, quality of life and adverse events (AEs). Results: Thirty-one subjects were enrolled and 29 completed the trial (26 female, mean age 49.5 years). While sleep was improved by both amitriptyline and nabilone, nabilone was superior to amitriptyline (ISI difference=3.2, 95% CI 1.2-5.3). Nabilone was marginally better on the restfulness (LSEQ difference=0.5 (0.0-1.0) but not on wakefulness (difference=0.3 (-0.2, 0.8)). Adverse events (AEs) were mostly mild to moderate and were more frequent with nabilone. Most common AEs for nabilone were dizziness, nausea and dry mouth. Conclusion: Nabilone is effective in improving sleep in patients with FM and is well tolerated. Low dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline. Longer trials are needed to determine the duration of effect and to characterize long-term safety. The trial was conducted following Good Clinical Practice guidelines and was registered at www.clinicaltrials.gov (registration number NCT00381199).

Primary study

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The effects of nabilone on insomnia in fibromyalgia: Results of a randomized controlled trial

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Conference Canadian Pain Society Conference, 2008; Victoria, British Columbia, Canada. Published in: Pain Research Management. 2008;13(2):111–130
Year 2009
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This article is not included in any systematic review

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Purpose: Fibromyalgia (FM) is a chronic pain syndrome with generalized tender points. Insomnia affects over 75% of patients with FM, and tricyclic antidepressants are the mainstay of treatment. Cannabis has been used by patients with FM to help sleep. We evaluated nabilone, a synthetic cannabinoid, for insomnia in FM. Method: We conducted a randomized double-blind active control equivalency crossover trial to compare nabilone (0.5-1.0mg qHS) to amitriptyline (10-20mg qHS) in FM patients with chronic insomnia. Subjects received each drug for two weeks with a two-week washout. The primary outcome was sleep quality using the Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ); secondary outcomes included pain, mood, quality of life and adverse events (AEs). Results: Thirty-one subjects were enrolled and 29 completed the trial (26 female, mean age 49.5y). While sleep was improved by both nabilone and amitriptyline, nabilone was superior to amitriptyline (ISI difference=3.2, 95%CI 1.2-5.3). Nabilone was marginally better on the restfulness LSEQ sleep quality scale (difference=0.5 (0.0-1.0) but not on wakefulness (difference=0.3 (-0.2, 0.8)). Adverse events were all mild-moderate and were more frequent with nabilone (102) than amitriptyline (53). Most common AEs for nabilone were dizziness (10), nausea (9) and dry mouth (7). Conclusion: Nabilone is effective in improving sleep in patients with FM and is well tolerated. Low dose nabilone given once daily at night may be considered as an alternative to amitriptyline. Longer trials are needed to determine the duration of effect and to characterize long-term safety.

Primary study

Unclassified

The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial

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Conference Canadian Rheumatology Association Meeting
Year 2009

This article is not included in any systematic review

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Abstract 149 J Rheumatol. 2009;36(11):2607

Primary study

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The effects of nabilone on sleep in fibromyalgia: Results of a randomized controlled trial

Journal Anesthesia and analgesia
Year 2010
Links Pubmed DOI

This article is included in 19 Systematic reviews Systematic reviews (19 references) 5 Broad syntheses Broad syntheses (5 references)

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Background: Sleep disorders affect many patients with chronic pain conditions. Cannabis has been reported by several patient populations to help sleep. We evaluated the safety and efficacy of nabilone, a synthetic cannabinoid, on sleep disturbance in fibromyalgia (FM), a disease characterized by widespread chronic pain and insomnia. Methods: We conducted a randomized, double-blind, active-control, equivalency crossover trial to compare nabilone (0.5-1.0 mg before bedtime) to amitriptyline (10-20 mg before bedtime) in patients with FM with chronic insomnia. Subjects received each drug for 2 wk with a 2-wk washout period. The primary outcome was sleep quality, measured by the Insomnia Severity Index and the Leeds Sleep Evaluation Questionnaire. Secondary outcomes included pain, mood, quality of life, and adverse events (AEs). Results: Thirty-one subjects were enrolled and 29 completed the trial (26 women, mean age 49.5 yr). Although sleep was improved by both amitriptyline and nabilone, nabilone was superior to amitriptyline (Insomnia Severity Index difference = 3.2; 95% confidence interval = 1.2-5.3). Nabilone was marginally better on the restfulness (Leeds Sleep Evaluation Questionnaire difference = 0.5 [0.0-1.0]) but not on wakefulness (difference = 0.3 [-0.2 to 0.8]). No effects on pain, mood, or quality of life were observed. AEs were mostly mild to moderate and were more frequent with nabilone. The most common AEs for nabilone were dizziness, nausea, and dry mouth. Conclusions: Nabilone is effective in improving sleep in patients with FM and is well tolerated. Low-dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline. Longer trials are needed to determine the duration of effect and to characterize long-term safety. © 2010 International Anesthesia Research Society.