Remeron May Provide Pain Relief in Fibromyalgia, Japanese Study Suggests

Remeron May Provide Pain Relief in Fibromyalgia, Japanese Study Suggests

Mirtazapine (Remeron) may be an effective pain relief treatment for fibromyalgia, according to a study based on the results from a Phase 2a clinical trial based in Japan.

Although mirtazapine is generally prescribed as an antidepressant, the trial showed that fibromyalgia patients who don’t exhibit symptoms of depression experienced a significant reduction in pain.

The study, “Efficacy of mirtazapine for the treatment of fibromyalgia without concomitant depression: a randomized, double-blind, placebo-controlled phase IIa study in Japan,” was published in the journal Pain.

Pregabalin (an antiepileptic drug) and duloxetine (a serotonin–noradrenaline reuptake inhibitor) are currently approved fibromyalgia treatments in Japan. Although not by the same mechanism, mirtazapine behaves similarly to serotonin–noradrenaline reuptake inhibitors. Additionally, prior studies have shown the therapy to be effective in decreasing pain, fatigue, and sleep disturbances in fibromyalgia.

Researchers in this clinical study sought to determine mirtazapine’s effectiveness at a fixed dosage in fibromyalgia patients and, to alleviate potential bias or conflicting effects, the study group excluded patients exhibiting depressive symptoms.

The study was performed over 12 weeks with 430 patients; half were given a placebo, while 30 mg (15 mg during the first week) of mirtazapine was administered daily to the other half. Patients kept daily pain diaries using a numerical rating score (NRS), judging pain from 0 to 10, and a weekly NRS was averaged. The mean was evaluated at each time point for each group (mirtazapine versus placebo).

Quality of life (QoL) was measured using the Japanese version of the Fibromyalgia Impact Questionnaire (JFIQ) at baseline, four, eight and 12 weeks, and the Japanese Short-form 36 Questionnaire (SF-36) version 2 — for physical, mental and social QoL assessment — was administered at baseline and week 12.

The mirtazapine mean NRS pain scores decreased gradually from week 2 through 8, and then remained constant and were significantly different than those reported from the placebo group.

They were also clinically meaningful, in that they are similar to those of approved Japanese treatments pregabalin and duloxetine. In addition, JFIQ total score increased from weeks 4 to 12, and assessment from the SF-36 showed mirtazapine to be more effective than the placebo, as well.

There were a few treatment-related adverse events with mirtazapine in 5% or more of the patients. These include: somnolence, or increase in duration of or desire for sleep (32.1%); weight gain (17.7%); nasopharyngitis (12.1%); and increased appetite (11.6%). These effects are similar to those seen in a previous study of Japanese patients that suffered depression.

The authors acknowledge that several more studies should be done. For example, the patients in this study were all Japanese between the ages 20 and 64 and not experiencing depression. Additional research can evaluate effectiveness in a more typical clinical setting.

In evaluating the measurements provided here, the authors concluded that “further confirmatory study should be designed to establish its benefit for the treatment of fibromyalgia.”

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Shelly Rae Rich is a freelance writer specializing in health and medical research. She holds a B.S. in Chemistry and worked as a laboratory technician at Washington University Medical School studying immunological characteristics of ulcerative colitis and Crohn's disease.

8 comments

  1. Denise Bault says:

    Anyone try Remeron in the US yet? Are there any docs trying this as a possible off label treatment for fibromyalgia sufferers? Is the FDA considering this as a possible treatment here? “Enquiring minds want to know…”

    • Kim says:

      I live in the US. I used it for over a year. I was prescribed the medication for sleep and to increase my appetite. It’s also prescribed for depression.

      So, there are a couple things to seriously consider before asking your doctor for this.

      1. Your weight – If you’re okay with gaining weight and slowing your metabolism, you’re good to go. If not, please know that you could gain weight easily and that weight won’t come off easily.

      2. Your brain – Remeron is an anticholinergic medication. This means it increases your chances of getting dementia. That’s some serious cause for concern.

      3. Withdrawal – if you use Remeron for a while and then you want to withdrawal, you will get serious rebound insomnia. When I weened off a small dosage, I couldn’t sleep for a good five weeks.

  2. Denise Bault says:

    Forgot to ask…just looked it up. It’s an anti-depressant. If it’s an anti-depressant, why wouldn’t they want to use it with fibromyalgia sufferers that are depressed? Study doesn’t say. I’m confused…

    • Kim says:

      Usually studies are done on people without concomitant disorders so it’s easier to determine results. I’m sure your doctor would prescribe the drug to you if you showed him or her evidence that it helps your fibro.

      Look into transcutaneous Vagus Nerve Stimulation. It helps with Fibromyalgia, Chronic Fatigue Syndrome, depression, migraines etc. Good luck!

  3. JJA says:

    To me, it sounds like someone else trying to just use an antidepressant because they think it’s all in our head. I guess we will just have to wait and see. Not impressed so far.

  4. Amy says:

    I was given Mirtazapine a few years back to help me gain weight back that I lost while on Lyrica. It did help pack the weight on. I did have less overall Fibromyalgia pain, but the amount of food I was eating was more then my 3 guys put together. I also slept a lot my 9 to 10 hours went to 13 to 15 hours. But the study is an interesting read. I live in the U.S.A.

  5. MIchele King says:

    I take mirtazapene 20 mg for depression and I’ve had lots of problems over the yes with weight gain, especially Elavil and pamelor made me raciness! Lyrics put abt 3 sizes from 18/20- to 26/28 in abt a month, I forgot the strength but it doesn’t matter I could not wear socks, shoes, rings I thought I was going to have a heart attack, I’ve had fibro/ interstitial cyctitous for abt 27 yes, I have extreme insomnia, I’ve got a new Dr and I think I’m going to see if there’s anything else, my Dr recently my pain Dr that is put me on Gralise its like neurontin I gained water weight on, but it helped only thing its $740.00! WOW!!

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