Nabilone was better than amitriptyline for improving sleep in fibromyalgia patients
In a crossover trial of 29 fibromyalgia patients, low-dose nabilone at bedtime improved sleep quality significantly more than amitriptyline, though neither affected pain, mood, or quality of life.
Quick Facts
What This Study Found
Twenty-nine fibromyalgia patients with chronic insomnia completed a crossover trial comparing nabilone (0.5-1.0 mg at bedtime) to amitriptyline (10-20 mg at bedtime), each for two weeks with a two-week washout period.
Nabilone was significantly superior to amitriptyline on the Insomnia Severity Index (difference = 3.2 points, 95% CI: 1.2-5.3). Nabilone was also marginally better for restfulness on the Leeds Sleep Evaluation Questionnaire.
However, neither drug improved pain, mood, or quality of life during the two-week treatment periods. Adverse effects were more common with nabilone and were mostly mild to moderate: dizziness, nausea, and dry mouth.
Key Numbers
29 completers (26 women, mean age 49.5). Nabilone dose: 0.5-1.0 mg. Amitriptyline dose: 10-20 mg. ISI difference: 3.2 points (95% CI: 1.2-5.3) favoring nabilone. No significant effects on pain, mood, or quality of life.
How They Did This
Randomized, double-blind, active-control, equivalency crossover trial. 31 enrolled, 29 completed (26 women, mean age 49.5). Each treatment period was 2 weeks with 2-week washout. Primary outcome: sleep quality (Insomnia Severity Index, Leeds Sleep Evaluation Questionnaire). Secondary outcomes: pain, mood, quality of life, adverse events.
Why This Research Matters
The study provided randomized controlled evidence that a cannabinoid could improve sleep in fibromyalgia more effectively than a commonly used first-line treatment, supporting cannabinoid consideration for sleep-related symptoms.
The Bigger Picture
This trial added to growing evidence for cannabinoids in managing sleep disturbances associated with chronic pain conditions, though the lack of effect on pain itself was notable.
What This Study Doesn't Tell Us
Small sample size (29). Short treatment duration (2 weeks each). Predominantly female sample. No placebo arm (only active comparator). Crossover design may have carry-over effects despite washout.
Questions This Raises
- ?Would longer treatment periods reveal pain benefits?
- ?Does nabilone maintain sleep improvement over months or years?
- ?Would a placebo-controlled design confirm the sleep benefit?
Trust & Context
- Key Stat:
- Nabilone beat amitriptyline by 3.2 points on Insomnia Severity Index
- Evidence Grade:
- Randomized, double-blind crossover trial with active comparator, but small sample size and short duration limit generalizability.
- Study Age:
- Published in 2010. Research on cannabinoids for fibromyalgia has continued with mixed results.
- Original Title:
- The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial.
- Published In:
- Anesthesia and analgesia, 110(2), 604-10 (2010)
- Authors:
- Ware, Mark A(14), Fitzcharles, Mary-Ann(14), Joseph, Lawrence, Shir, Yoram
- Database ID:
- RTHC-00462
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
Does nabilone help fibromyalgia patients sleep?
In this small trial, nabilone (0.5-1.0 mg at bedtime) improved sleep quality significantly more than amitriptyline over two weeks, though it did not improve pain, mood, or quality of life during that period.
What are the side effects of nabilone for sleep?
Side effects were mostly mild to moderate and more common with nabilone than amitriptyline: dizziness, nausea, and dry mouth were the most frequently reported.
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Cite This Study
https://rethinkthc.com/research/RTHC-00462APA
Ware, Mark A; Fitzcharles, Mary-Ann; Joseph, Lawrence; Shir, Yoram. (2010). The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial.. Anesthesia and analgesia, 110(2), 604-10. https://doi.org/10.1213/ANE.0b013e3181c76f70
MLA
Ware, Mark A, et al. "The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial.." Anesthesia and analgesia, 2010. https://doi.org/10.1213/ANE.0b013e3181c76f70
RethinkTHC
RethinkTHC Research Database. "The effects of nabilone on sleep in fibromyalgia: results of..." RTHC-00462. Retrieved from https://rethinkthc.com/research/ware-2010-the-effects-of-nabilone
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.