Ware MA, Fitzcharles MA, Joseph L, Shir Y
The Effects of Nabilone on Sleep in Fibromyalgia: Results of a Randomized
Controlled Trial.
Anesth Analg 2009 Dec 10.
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.
