What is the recommended dose of nabilone (Cesamet) as an adjunct for fibromyalgia?

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From the Guidelines

The recommended dose of nabilone as an adjunct for fibromyalgia is not directly established in the provided evidence, but based on its use in other conditions, a dose of 0.5 mg to 3 mg may be considered, with a starting dose of 0.5 mg and titration based on efficacy and tolerability. When considering the use of nabilone for fibromyalgia, it's essential to look at its application in similar contexts, such as the treatment of PTSD-associated nightmares, where a dosage starting at 0.5 mg and titrated to a maximum of 3 mg was used 1. Key points to consider when prescribing nabilone include:

  • Starting with a low dose, such as 0.5 mg, to assess patient tolerance and response.
  • Gradually increasing the dose based on efficacy and tolerability, up to a maximum of 3 mg.
  • Monitoring for common side effects such as dry mouth and headache, as reported in studies like the one on PTSD-associated nightmares 1.
  • Being aware of the potential for sedative effects and advising patients accordingly on activities such as driving or operating machinery. Given the lack of direct evidence for fibromyalgia, the approach should be cautious, with close monitoring of the patient's response and adjustment of the dose as needed, prioritizing the patient's quality of life and minimizing potential morbidity and mortality risks.

From the Research

Recommended Dose of Nabilone for Fibromyalgia

The recommended dose of nabilone as an adjunct for fibromyalgia is not consistently established across all studies. However, some studies provide insight into the dosages used in clinical trials:

  • A study from 2016 2 mentions that nabilone was used with a bedtime dosage of 1 mg/day.
  • A study from 2008 3 used nabilone, starting with 0.5 mg PO at bedtime and titrating up to 1 mg BID over 4 weeks.
  • A study from 2010 4 used nabilone at a dose of 0.5-1.0 mg before bedtime.

Efficacy and Safety of Nabilone for Fibromyalgia

The efficacy and safety of nabilone for fibromyalgia have been investigated in several studies:

  • A 2016 review 2 found that the evidence for the use of nabilone in fibromyalgia was of very low quality and did not support its use due to limited data and high risk of bias.
  • A 2008 study 3 found that nabilone appeared to be a beneficial and well-tolerated treatment option for fibromyalgia patients, with significant benefits in pain relief and functional improvement.
  • A 2010 study 4 found that nabilone was effective in improving sleep in patients with fibromyalgia and was well tolerated, although it had more frequent adverse events compared to amitriptyline.

Key Findings

Key findings from the studies include:

  • Nabilone may be beneficial for pain relief and functional improvement in fibromyalgia patients 3.
  • Nabilone can improve sleep in patients with fibromyalgia 4.
  • The most common adverse events associated with nabilone are dizziness, nausea, dry mouth, and drowsiness 2, 3, 4.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Cannabinoids for fibromyalgia.

The Cochrane database of systematic reviews, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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