Nabilone was better than amitriptyline for improving sleep in fibromyalgia patients | Research

The takeaway

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.

Read this if you have fibromyalgia and are interested in cannabinoid options for sleep improvement.

Nabilone beat amitriptyline by 3.2 points on Insomnia Severity Index

What the researchers 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.

Why it 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 numbers in context

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 the study worked

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.

What this study cannot 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.

How to read the evidence

Randomized, double-blind crossover trial with active comparator, but small sample size and short duration limit generalizability.

When this study was published

Published in 2010. Research on cannabinoids for fibromyalgia has continued with mixed results.

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.

Questions still open

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?

Common 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.

Read the original research

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

Anesthesia and analgesia, 110(2), 604-10

View on PubMed ↗Publisher’s paper ↗

Citation

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