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

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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Pain Clinic, McGill University Health Centre, Montreal, Quebec, Canada. mark.ware@muhc.mcgill.c

    , ,

    Source

    Anesthesia and analgesia 110:2 2010 Feb 01 pg 604-10

    MeSH

    Adult
    Aged
    Amitriptyline
    Anti-Anxiety Agents
    Antidepressive Agents
    Cross-Over Studies
    Double-Blind Method
    Dronabinol
    Female
    Fibromyalgia
    Humans
    Male
    Middle Aged
    Pain Measurement
    Patient Satisfaction
    Sleep
    Sleep Initiation and Maintenance Disorders

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    20007734

    Citation

    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/full_citation/The_Effects_of_Nabilone_on_Sleep_in_Fibromyalgia:_Results_of_a_Randomized_Controlled_Trial_ L2 - http://Insights.ovid.com/pubmed?pmid=20007734 ER -