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The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial.
Anesth Analg 2010; 110(2):604-10A&A

Abstract

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.

Authors+Show Affiliations

Pain Clinic, McGill University Health Centre, Montreal, Quebec, Canada. mark.ware@muhc.mcgill.cNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20007734

Citation

Ware, Mark A., et al. "The Effects of Nabilone On Sleep in Fibromyalgia: Results of a Randomized Controlled Trial." Anesthesia and Analgesia, vol. 110, no. 2, 2010, pp. 604-10.
Ware MA, Fitzcharles MA, Joseph L, et al. The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial. Anesth Analg. 2010;110(2):604-10.
Ware, M. A., Fitzcharles, M. A., Joseph, L., & Shir, Y. (2010). The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial. Anesthesia and Analgesia, 110(2), pp. 604-10. doi:10.1213/ANE.0b013e3181c76f70.
Ware MA, et al. The Effects of Nabilone On Sleep in Fibromyalgia: Results of a Randomized Controlled Trial. Anesth Analg. 2010 Feb 1;110(2):604-10. PubMed PMID: 20007734.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial. AU - Ware,Mark A, AU - Fitzcharles,Mary-Ann, AU - Joseph,Lawrence, AU - Shir,Yoram, Y1 - 2009/12/10/ PY - 2009/12/17/entrez PY - 2009/12/17/pubmed PY - 2010/2/9/medline SP - 604 EP - 10 JF - Anesthesia and analgesia JO - Anesth. Analg. VL - 110 IS - 2 N2 - 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. SN - 1526-7598 UR - https://www.unboundmedicine.com/medline/citation/20007734/The_effects_of_nabilone_on_sleep_in_fibromyalgia:_results_of_a_randomized_controlled_trial_ L2 - http://dx.doi.org/10.1213/ANE.0b013e3181c76f70 DB - PRIME DP - Unbound Medicine ER -