Treatment with Remeron (mirtazapine) may improve pain, sleep, and quality of life in patients with fibromyalgia, a Department of Veterans Affairs review study suggests.
But more long-term studies are needed to provide additional clinical evidence of Remeron’s therapeutic effects in these patients, the authors said.
The study, “The role of mirtazapine in patients with fibromyalgia: a systematic review,” was reported in the journal Rheumatology International.
Patients with fibromyalgia are often treated with several medications, including antidepressants, anti-convulsants, muscle relaxants, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. While they have shown to be effective in treating some specific symptoms, these therapies often fail to effectively treat the complete list of symptoms linked to fibromyalgia.
Remeron is an antidepressant that has been approved by the U.S. Food and Drug Administration for the treatment of major depressive disorders. The drug can increase the release of some brain signaling molecules, and it can also inhibit the activity of others.
Its broad mode of action helps explain why Remeron can modulate mood as well as act as a sedative, at the same time helping to manage sleep disturbances.
Previous studies have suggested that Remeron could be a potential treatment for fibromyalgia, but until now its use has not been recommended by The European League Against Rheumatism (EULAR).
To further evaluate its potential in fibromyalgia, a team at the Durham Veterans Affairs Medical Center reviewed information available in the literature. The analysis included data from three randomized, placebo-controlled trials and one open-label trial.
These studies showed that Remeron showed positive effects on measures of pain, sleep, and quality of life in patients with fibromyalgia who had not received treatment before, or who had failed previous treatment options.
Two studies found that the antidepressant drug could significantly reduce pain compared to baseline (the start of the study), whereas the other two showed improvements compared to placebo.
Because each study used different methods to measure pain, it limits the ability to compare the different results. Still, this limitation can also be viewed as a strength, since independently, the methods used to assess Remeron’s effectiveness to manage pain were demonstrated in all four studies.
“This may also contribute to more generalizable results that can be applied to a broader range of patients with fibromyalgia,” the researchers wrote.
The studies also revealed that treatment with Remeron could improve the quality of life of these patients, as it was seen to significantly improve emotional role functioning and bodily pain. Other domains such as mental health, vitality, and general health were also found to be positively impacted by the drug.
“The finding that mirtazapine [Remeron] can positively impact quality of life is important as patients with fibromyalgia report a high impact on their quality of life due to disease burden,” the authors said.
Also, treatment with 15-30 mg of Remeron daily for over a period of one to two weeks was found to improve sleep disturbances by 73 percent and significantly reduce fatigue in about half the patients.
The most common adverse effects associated with the treatment reported in the four trials were dry mouth, increased appetite, somnolence, sleepiness, low blood pressure, weight gain, and inflammation of the throat and nose.
Based on these results, the authors believe Remeron can be “an effective option for fibromyalgia due to its ability to improve pain, fatigue, quality of life, and sleep symptoms.”
“A key difference when compared to other treatment options is that mirtazapine targets many of the symptoms of fibromyalgia with its mechanism of action and simple once daily dosing,” they said.
Another potential benefit of this drug is its cost. In the U.S., a one-month supply of Remeron can cost about $80, which is about three to six times less than other available medications.
More studies are needed to provide additional clinical evidence and further define the role of Remeron for patients with fibromyalgia, the authors said.