Fibromyalgia Pain Reduced by Low-Dose Naltrexone

Pain Management

Fibromyalgia is a chronic pain disorder characterized by diffuse musculoskeletal pain, fatigue, sleep disturbance and cognitive impairment. A significant number of fibromyalgia patients do not respond adequately to the current drugs (pregabalin, milnacipran, duloxetine) approved for fibromyalgia treatment by the Food and Drug Administration (FDA). Thus, there is still a need for adjunctive therapies. 

LDN has been found to be a beneficial, highly tolerable, and inexpensive treatment to reduce daily pain in patients with fibromyalgia. In a single-blind, crossover pilot clinical trial at the Division of Pain Management, Stanford University, LDN reduced fibromyalgia symptoms in ten women meeting criteria for fibromyalgia, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory tests showed that mechanical and heat pain thresholds were improved by LDN. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to LDN. It is hypothesized that LDN causes transient blockade of opioid receptors centrally resulting in a rebound of endorphin function which may attenuate pain in fibromyalgia. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient.

A placebo-controlled, double-blind trial was sponsored by the American Fibromyalgia Syndrome Association and reported at the American Academy of Pain Medicine’s 28th Annual Meeting in February, 2012.  In the new trial, Jarred Younger, PhD, and colleagues from Stanford University, Palo Alto, California, evaluated 30 women with fibromyalgia (average age, 43 years), completing 2 weeks of baseline measurements, 12 weeks of LDN treatment (4.5 mg each day), 4 weeks of placebo, and 4 weeks of follow up. 

The primary outcome for all patients was reduction of daily pain, reported through patient symptom severity reports via handheld computer. At the end of the trial, patients reported a 43% reduction in pain during the LDN treatment when compared to the placebo treatment. The only major side effects reported more frequently during the LDN phase of treatment were vivid dreams (37% in LDN vs 13% in placebo) and headache (16% in LDN vs 3% in placebo). During both treatment phases, patients reported similar tolerability (89.2 vs 89.4 out of 100). Further study is warranted.

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Naltrexone is not commercially available in a 4.5 mg dose, but our pharmacy can compound LDN by prescription.


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Compounding requires a relationship between the patient, physician and pharmacist, so providing your current physician's name is helpful.