What is the role of mirtazapine in the treatment of fibromyalgia?

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Last updated: April 30, 2025View editorial policy

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From the Guidelines

Mirtazapine can be considered for the treatment of fibromyalgia, particularly for patients with sleep disturbances and depression, as it may help improve sleep quality and reduce pain sensitivity. The most recent and highest quality study, 1, suggests that there is insufficient evidence to recommend for or against the use of mirtazapine for the treatment of pain and improved functional status in patients with chronic multisymptom illness, including fibromyalgia. However, another study, 1, recommends a multidisciplinary approach to managing fibromyalgia, including non-pharmacological and pharmacological treatment modalities tailored to the individual patient's needs.

Some key points to consider when using mirtazapine for fibromyalgia include:

  • Starting with a low dose, such as 7.5-15mg, and gradually increasing as needed and tolerated
  • Taking the medication consistently each night to allow for optimal effects on sleep and pain regulation
  • Monitoring for common side effects, such as daytime drowsiness, increased appetite, weight gain, and dry mouth
  • Combining mirtazapine with non-medication strategies, such as gentle exercise, stress management, and cognitive behavioral therapy, for optimal management of fibromyalgia symptoms

It's also important to note that other medications, such as serotonin-norepinephrine reuptake inhibitors and pregabalin, may be recommended for the treatment of pain and improved functional status in patients with fibromyalgia, as suggested by 1. Ultimately, the decision to use mirtazapine or other medications for fibromyalgia should be made on a case-by-case basis, taking into account the individual patient's needs and medical history.

From the Research

Mirtazapine for Fibromyalgia

  • Mirtazapine has been investigated as a potential treatment for fibromyalgia due to its effects on multiple neurotransmitters 2, 3.
  • Studies have shown that mirtazapine can improve pain, sleep, and quality of life in patients with fibromyalgia 2, 3, 4.
  • A systematic review found that mirtazapine resulted in improvements in pain, sleep, and quality of life in patients with fibromyalgia, with minor occurrences of somnolence, weight gain, nasopharyngitis, dry mouth, and increased appetite 2.
  • An open trial found that 38% of patients with fibromyalgia were considered responders to mirtazapine treatment, with reductions in pain, fatigue, and sleep disturbances 3.
  • A randomized controlled trial found that mirtazapine 30 mg/day resulted in significant within-group improvements in pain and sleep, but the between-group difference was not significant 4.

Efficacy and Safety of Mirtazapine

  • A Cochrane review found that mirtazapine showed a clinically-relevant benefit compared to placebo for some secondary outcomes, including participant-reported pain relief of 30% or greater, reduction of mean pain intensity, and sleep problems 5.
  • However, the review also found that mirtazapine was associated with a higher risk of somnolence, weight gain, and elevated alanine aminotransferase compared to placebo 5.
  • A pilot study found that mirtazapine was well tolerated, with common adverse events including increased appetite and weight gain 4.

Comparison to Other Treatments

  • A study found that patients with fibromyalgia who were newly prescribed amitriptyline, duloxetine, gabapentin, or pregabalin had similar clinical characteristics and medication use patterns, but only one-fifth of patients continued the treatment started for ≥1 year 6.
  • Mirtazapine was not included in this study, but the findings suggest that patients with fibromyalgia may have similar responses to different treatments, and that treatment adherence is a significant issue in this population.

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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