2015-12-14

Sufferers of fibromyalgia are finally being heard—and treated. For years, the condition’s origins were so baffling to researchers that fibromyalgia was actually classified on the spectrum of psychosomatic illnesses. Now, with better testing, data and a fuller understanding of the condition, current health models assess fibromyalgia as a syndrome related to over-sensitization of the central nervous system, and new treatments like the use of muscle relaxants are becoming more common.

Fibromyalgia affects more than 5 million people in the U.S., the majority of them adult women, at a rate of 7 to 1 compared with cases in men or children, and now that it’s no longer treated as a psychosomatic illness, fibromyalgia treatment and medications have made vast leaps forward.1

Fibromyalgia treatment may be awakening to a new era, but many FM patients still find themselves with their own issues of sleeplessness. The chronic pain, high sensitivity and nervous system disorder associated with the condition can often keep patients from being able to fall into deep sleep or maintaining sleep. While many FM medications target more obvious elements of the disease like the patient’s chronic pain, recent studies have shown that a bedtime treatment regimen of muscle relaxants like cyclobenzaprine can improve fibromyalgia patients’ sleep quality. For pharmacists with FM patients, this could be a game-changer in how to approach FM treatment.

Effects of Cyclobenzaprine on Fibromyalgia Sleep Physiology

Cyclobenzaprine is classified as a muscle relaxant, but in structure it much more closely resembles a tricyclic antidepressant (TCA) like amitriptyline. Because TCAs increase synaptic concentrations in spinal neurons by inhibiting the reuptake of norepinephrine and serotonin, it’s believed they also work as an FM treatment because they cause an analgesic effect in the descending pain pathways.2

Prior to the approval of specific fibromyalgia medications, TCAs were actually considered the best first-line treatment option because of their effectiveness in promoting sleep and reducing pain. When looking for better solutions for symptoms and sleep physiology of FM patients, researchers zeroed in on cyclobenzaprine, structurally a TCA but with the additional analgesic benefits of muscle relaxants.3

A meta analysis of five clinical trials totaling 312 patients revealed positive results from bedtime doses of cyclobenzaprine ranging from 10 to 30 mg daily. Three times as many patients on the cyclobenzaprine dose reported improved sleep over a 12-week testing period compared with the placebo, as well as improvements in core FM symptoms, nonrestorative sleep and associated fatigue symptoms.

The researchers readily admitted several weaknesses of the study, including a high number of patients who did not finish the entire trial, and a relatively high percentage—85 percent—reporting at least one adverse side effect from the cyclobenzaprine treatment. For a compounding pharmacist, however, the results related to improved sleep should be reason enough to explore cyclobenzaprine as part of an FM treatment regimen, since it might be possible to compound doses and reduce specific reported adverse side effects.4

In conjunction with a patient’s physician, compounding pharmacists can assess whether cyclobenzaprine may be a good option. Patients who are good candidates for cyclobenzaprine therapy include those whose physicians believe they have exhausted conventional therapies for sleep disruption related to fibromyalgia. Pharmacists may also work with patients and physicians to incorporate cyclobenzaprine if patients experience adverse reactions to other therapies designed to alleviate fibromyalgia pain and sensitivity during sleep.

How Compounding Pharmacists Can Use Muscle Relaxants in Fibromyalgia Therapy

Because fibromyalgia can present as many different symptoms without clear biological markers, finding a diagnostic treatment regimen can be a long and frustrating process for patients. During the time that patients will be consulting with various doctors and specialists for their condition, however, they will be turning to their pharmacist for relief from chronic pain.5

Compounding pharmacists have a distinct role to play in chronic conditions involving pain like fibromyalgia. For a condition in which the symptoms may present in various areas of the body and with varying levels of severity, compounded medications to provide personalized treatment are crucial. Taking into account a patient’s medical history, specific FM symptoms and how a patient prefers to take the medication, compounding FM medications can significantly lower side effects and adjust doses for optimum results.6

By staying up to date on emerging research in pharmacological breakthroughs, the compounding pharmacist is in a unique position to evolve treatment forward for chronic conditions like fibromyalgia pain and sleep physiology issues. The environment of compounding, where patient care comes first and personalized treatment is prioritized, can be an ideal place to explore emerging forms of treatment for conditions like fibromyalgia.

If a compounding pharmacist’s patient has undergone other treatments for fibromyalgia or is in a current FM treatment regimen but still finds sleep disruption a life-altering issue, muscle relaxants like cyclobenzaprine are a potential solution worth looking into. Like many multi-symptomatic conditions, treatment for fibromyalgia requires a multi-dimensional response where pharmacology is part of a process that can include patient education and physical therapy. Treating related sleep disorders with muscle relaxants like cyclobenzaprine can pay dividends in every area of the patient’s treatment plan, leading to highly improved quality of life.

Pharmaceutica North America is a premier provider of high-quality bulk and unit-dose APIs. Contact us to learn more about our APIs such as cyclobenzaprine, or to learn more about our other active kits.

“Fibromyalgia,” April 23, 2015, http://www.cdc.gov/arthritis/basics/fibromyalgia.htm; “Fibromyalgia: A Clinical Update,” Sept. 2013, http://jaoa.org/article.aspx?articleid=2094606 ↩

“Pharmacotherapy of Fibromyalgia,” July 15, 2011, http://www.medscape.com/viewarticle/745907_6 ↩

“Fibromyalgia: A Clinical Update,” ibid. ↩

“Effects of Bedtime Very Low Dose Cyclobenzaprine on Symptoms and Sleep Physiology in Patients with Fibromyalgia Syndrome: A Double-blind Randomized Placebo-controlled study,” Sept. 1, 2011, http://www.jrheum.org/content/38/12/2653.full ↩

“Help for the Pain: The Pharmacist’s Role in Treating Fibromyalgia,” accessed Dec. 4, 2015, http://www.freece.com/Documents/Fibromyalgia%20v2.pdf ↩

“Fibromyalgia and the Pharmacist’s Role,” May 1, 2012, http://www.uspharmacist.com/continuing_education/ceviewtest/lessonid/108249/ ↩

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