The individualistic nature of fibromyalgia is such that no one particular Fibromyalgia Medication is most effective for all individuals. In fact, a medication that brings great benefit to one person may not have any effect on the symptoms of another.
Fibromyalgia is difficult to treat and it often takes a considerable amount of trial and error on behalf of patients and their physicians to find the right combination of therapies. Medications that are frequently used by patients include prescription medications approved by the U.S. Food and Drug Administration (FDA) to treat fibromyalgia, as well as common over-the counter and prescription pain relievers, antidepressant medications, and anticonvulsant medications. It is important to understand that although only three medications are approved by the FDA for treating fibromyalgia, a wide variety of other drugs are often prescribed off-label by physicians when conventional therapies prove ineffective or are not well-tolerated by patients. Many of these uses are not backed by direct scientific research supporting their effectiveness for treating fibromyalgia. This does not, however, mean that they will be ineffective. Each patient experiences different symptoms, and each responds to medications in a different manner. Anecdotal evidence collected by physicians with extensive experience treating fibromyalgia is often the basis for prescribing unconventional therapies.
This article is designed to provide a high-level overview of these groups of Fibromyalgia Medications and their use in treating fibromyalgia. Please refer to individual articles referenced on specific therapies for more detailed information on Fibromyalgia medication.
FDA Approved Treatments for Fibromyalgia
Currently, there are only three Fibromyalgia Medications approved by the FDA for the treatment of fibromyalgia. These include Savella (milnacipran HCl), Lyrica (pregabalin), and Cymbalta (duloxetine HCl). Although each of these medications has shown considerable usefulness in managing fibromyalgia-related pain and improving overall functioning in fibromyalgia patients, they are not universally effective for all who try them. Furthermore, it is important to understand that while these medications may provide some degree of relief for many patients, they will not cure fibromyalgia.
Savella was approved by the FDA in January of 2009 for the treatment of fibromyalgia pain and to improve overall functioning in fibromyalgia patients, following its demonstrated safety and efficacy in four randomized, double-blind, placebo-controlled trials (the “gold standard” of research design for studies investigating the effectiveness of a treatment) (Clauw et al., 2008; Mease et al., 2009; Arnold et al., 2010; Branco et al., 2010). Savella is in a class of drugs known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs), which work to regulate the neurotransmitters serotonin and norepinephrine in the brain. Savella is taken in tablet form, and the recommended dose of Savella is 100 mg/day, although dosage levels may vary depending on individual patient characteristics and response. Some patients will notice improving symptoms within a week, however others may not notice improvement for several weeks.
Common side effects of Savella include nausea, dizziness, headache, blurred vision, decreased sexual desire or ability, constipation, insomnia, hot flashes, excess sweating, vomiting, heart palpitations, increased heart rate, dry mouth, and high blood pressure. Potentially serious side effects include hallucinations, confusion, difficulty concentrating, weakness, unsteady gait, seizures, decreased speed of breathing, rash, yellowing of the skin or eyes, flu-like symptoms, bloody stools or vomit, and unexplained bleeding or bruising (including nosebleeds). Savella also has the potential to increase suicidal thoughts in children, teenagers, and young adults, therefore it is not approved for use by anyone under the age of 18. Savella interacts negatively with a variety of medications, and should not be used by anyone with any of the following conditions: high blood pressure, heart disease, abnormal heart rhythm, increased heart rate, kidney problems, urinary difficulties, current or prior history of manic episodes, seizure disorders, and/or bleeding disorders.
Lyrica (pregabalin) is also FDA approved for fibromyalgia, and was the first prescription medication approved to treat fibromyalgia-related pain. It is also approved to treat pain associated with nerve damage and with shingles. Lyrica is also sometimes used along with other medications to treat seizure disorders like epilepsy. Lyrica is in the class of drugs known as anticonvulsants, however the way in which it works to treat fibromyalgia pain is not well-understood. It is believed that Lyrica may help maintain the balance of various chemicals in the body and thereby calm overactive nerves. Lyrica will not work for all fibromyalgia patients, however many have been able to see noticeable improvements in pain, sleep quality, and overall functioning. Two randomized, placebo-controlled trials have supported these observations, including a 2008 study that showed significant improvements in pain and sleep among those who took Lyrica when compared to those who received placebo (Arnold et al., 2008). Other randomized, placebo-controlled studies have also demonstrated the efficacy and safety of Lyrica (Crofford et al., 2008).
Lyrica is taken two or three times a day in a capsule, generally at a dose of 300mg to 450mg per day. Common side effects of Lyrica include fatigue, dizziness, headache, dry mouth, nausea, vomiting, constipation, gas, bloating, elevated mood, difficulty with speech or concentration, confusion or forgetfulness, anxiety, unsteadiness and/or loss of balance, poor coordination, uncontrollable shaking or jerking, twitching muscles, increased appetite and/or weight gain, swelling of the legs or arms, and back pain. Serious side effects include vision changes; hives, rash, itching, swelling of the face, throat, mouth, lips or tongue (signs of an allergic reaction); blisters; shortness of breath; wheezing; muscle pain or tenderness accompanied by a fever; and chest pain. Lyrica should be used with caution by individuals with diabetes, and should not be used by pregnant women unless the benefits to the mother outweigh any potential risks to the fetus. Individuals taking ACE-inhibitors, which are commonly prescribed to treat high blood pressure, may be at an increased risk for swelling and hives. Concurrent use of alcohol, opiate pain medications, and certain anti-anxiety medications may increase the risk of dizziness and sleepiness.
Cymbalta (duloxetine HCl) was originally developed as an anti-depression medication. Following two randomized, double-blind, placebo-controlled trials that showed Cymbalta to be safe and effective at treating fibromyalgia pain (Arnold et al., 2005; Russell et al., 2008) , the FDA approved Cymbalta as a treatment for fibromyalgia in 2008. Since gaining FDA approval, researchers have continued to study Cymbalta, and studies have consistently demonstrated its effectiveness in a variety of therapeutic settings (Bennett et al., 2012; Choy et al., 2011). In addition to its approval for treating depression and fibromyalgia, Cymbalta is also approved to treat generalized anxiety disorder, diabetic nerve pain, and for the management of chronic musculoskeletal pain resulting from conditions such as chronic osteoarthritis and chronic low back pain. Therefore, Cymbalta is often an attractive choice for fibromyalgia patients, since it is approved to treat a number of co-morbid conditions that commonly occur alongside fibromyalgia. Like Savella, Cymbalta is in the SNRI drug class and is believed to exert its effects on pain by regulating levels of specific neurotransmitters in the body.
Cymbalta is taken as a capsule once per day, at a dose of 20mg to 60mg. The most common side effects associated with Cymbalta when used to treat fibromyalgia include nausea, daytime sleepiness, fatigue, constipation, dizziness, agitation, decreases in appetite, dry mouth, and increased sweating. Side effects reported for Cymbalta when used for its other approved indications include heart palpitations, vertigo, blurred vision, chills, rash, and hot flushes. Similar to Savella, Cymbalta has the potential to worsen depressive symptoms or increase suicidal thoughts or behavior in young adults and children, and therefore it is not approved for use by anyone under 18 years of age. Cymbalta can also interact negatively with a number of medications, and can cause low blood pressure to occur when rising from a seated position to standing. In addition, Cymbalta should not be taken by individuals who have any of the following conditions: liver disease or those who have a history of heavy alcohol use, narrow-angle glaucoma, kidney problems, seizure disorders, abnormal blood pressure, or digestive difficulties.
Medications for Associated Conditions and Symptoms
Due to the large number of associated conditions that commonly occur alongside fibromyalgia, such as sleep disturbances and depression/anxiety, many other medications are frequently prescribed to fibromyalgia patients in an effort to treat either the condition itself or the associated symptoms. Such medications include prescription sleep aids, antidepressant medications, anticonvulsant medications, muscle relaxants, and opiate pain medications.
Insomnia and other sleep-related disorders are common among fibromyalgia patients, and may be due in part to the persistent pain and fatigue associated with fibromyalgia and their unrelenting effects on the body. Fortunately, a number of prescription sleep medications are available, many of which are effective at improving sleep duration and decreasing the time needed to fall asleep; however, these medications are generally not intended for long-term use and can cause considerable side effects. Examples of popular prescription sleep medications include Lunesta (eszopiclone), Rozerem (ramelteon), Sonata (zaleplon), Ambien (zolpidem), and Imovane (zopiclone; available only in Canada). Most of these medications work by slowing brain activity in order to promote sleep. They are designed to be taken immediately before bedtime, on nights when individuals can devote a full eight hours to sleep. They typically cause noticeable sedation soon after they are taken, and work most effectively when consumed on an empty stomach. In general, their maximum effects on sleep are achieved within a week to 10 days after starting therapy.
Common side effects for most prescription sleep aids include the risk of dependency, daytime drowsiness, changes in mental status, sleepwalking, impaired memory, difficulty concentrating, problems with coordination, allergic reaction, constipation, diarrhea, heartburn, and increased menstrual bleeding. Most of these drugs also interact negatively with a wide variety of medications, including drugs used to treat depression, fungal infections, colds and allergies, bacterial infections, anxiety, and anti-seizure medications. In addition, the sedative effects of prescription sleep aids can be intensified dramatically by the concurrent use of alcohol or sedative medications. Along the same lines, and also due to the risk of dependency, individuals who have a history of alcohol abuse, illicit drug use, or prescription drug misuse should use prescription sleep aids carefully, if at all.
The term antidepressants is broadly used to describe a class of drugs that are commonly used to treat a variety of mental health conditions, including depression, anxiety, and mood disorders, among others. In general, antidepressants affect the production of neurotransmitters, which helps to regulate the transmission of nerve (and pain) signaling in the body. The four main sub-classes of antidepressants include 1) tricyclic antidepressants (TCAs); 2) monoamine oxidase inhibitors (MAOIs); 3) selective serotonin reuptake inhibitors (SSRIs); and 4) serotonin and norepinephrine reuptake inhibitors (SNRIs).
Tricyclic antidepressants were among the first antidepressants developed and they work by blocking the absorption (also called reuptake) of the neurotransmitters norepinephrine and serotonin. Common TCAs include amitriptyline (Elavil), clomipramine (Anafranil), desipramine (Norpramin), nortriptyline (Pamelor), and imipramine (Tofranil). Despite their effectiveness, TCAs can cause considerable side effects and therefore are often not the first type of antidepressant therapy prescribed for patients. These side effects include dry mouth, vision disturbances, increased fatigue, low blood pressure, drowsiness, weight gain, tremors, constipation, bladder problems, daytime sleepiness, increased heart rate, sensitivity to sunlight, sexual problems, and changes in blood glucose (sugar) levels. TCAs should be used with caution by individuals with any of the following conditions: diabetes, narrow-angle glaucoma, enlarged prostate, cardiac problems, thyroid problems, or a history of seizures.
Monoamine oxidase inhibitors were the first type of antidepressant developed, and they help increase the availability of the neurotransmitters norepinephrine, serotonin, and dopamine in the brain. Examples of common MAOIs include tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Emsam, Zelapar), and isocarboxazid (Marplan). Patients who take MAOIs must eat strict diets and adhere to closely-monitored medication regimens, as MAOIs interact with substances in many foods and beverages, as well as a considerable number of other medications. MAOIs can have serious side effects as well, which often makes them an unattractive treatment option for many patients. These include daytime sleepiness, dizziness, low blood pressure, diarrhea, disturbances in taste, nervousness, muscle aches, insomnia, weight gain, decreased libido, erectile dysfunction, urinary difficulty, tingling sensations in the skin, headache, racing heartbeat, chest pain, neck stiffness, nausea, and vomiting. As a result of their various side effects and necessary dietary and medication restrictions, MAOIs are typically used as a last resort when other antidepressant therapies have failed or are not tolerated by patients.
Selective serotonin reuptake inhibitors are a relatively new class of antidepressants, yet they are usually the first line of therapy for many depressed patients. SSRIs block the absorption of serotonin in the brain, making it more available. Commonly prescribed SSRIs include fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), escitalopram (Lexapro), and citalopram (Celexa). Similar SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs) increase the availability of the neurotransmitters serotonin and norepinephrine in the brain.
Common examples of these medications include venlafaxine (Effexor), mirtazapine (Remeron), duloxetine (Cymbalta), desvenlafaxine (Pristiq), and milnacipran (Savella).
Because all SSRIs tend to work in a similar manner, they have similar side effect profiles, which include: dizziness, headache, nausea, insomnia, nervousness or restlessness, dry mouth, diarrhea, rash, increased sweating, weight gain, drowsiness, and sexual side effects. Common side effects associated with the use of SNRIs include drowsiness, vision disturbances, feeling lightheaded, strange dreams, constipation, fever and/or chills, headache, changes in appetite, tremors, dry mouth, heart palpitations, difficulty urinating, agitation or anxiety, insomnia, muscle weakness, and nausea. Both SSRIs and SNRIs may potentially interfere with blood thinning medications such as Coumadin and aspirin. Finally, all antidepressants, regardless of class, may increase the risk of suicide in children, adolescents, and young adults.
Antidepressants are frequently prescribed to fibromyalgia patients, as many suffer from depression and anxiety. In addition, some research has shown that certain antidepressants may actually improve pain, fatigue and sleep (in addition to depression) among fibromyalgia patients. TCAs are the most frequently used for this purpose, notably amitriptyline, however the considerable number of side effects that accompany the use of TCAs makes their widespread use for fibromyalgia pain and fatigue limited. Fortunately, newer antidepressants in the SNRI class have recently proven to be effective at treating not only depression in fibromyalgia patients, but also pain and other symptoms (Arnold, 2007; Moret & Briley, 2006; Hauser et al., 2009).
Skeletal muscle relaxants include a broad group of medications that are approved by the FDA to treat muscle spasticity caused by a variety of conditions and factors. There are two types of muscle relaxants: antispasticity agents and antispasmodic agents. Antispasticity agents are used to treat conditions such as cerebral palsy, multiple sclerosis, traumatic brain injury, or individuals who have sustained injury to their spinal cord. Antispasmodic medications are generally prescribed for individuals who have experienced an acute musculoskeletal problem, such as tension headaches, and lower back or neck pain. The only skeletal muscle relaxant drugs that are FDA approved to treat spasticity are baclofen (Lioresal®), dantrolene (Dantrium®), and tizanidine (Zanaflex®). Examples of antispasmodic medications include carisoprodol (Soma®), chlorzoxazone (Parafon Forte DSC®), cyclobenzaprine (Flexeril®), metaxalone (Skelaxin®), methocarbamol (Robaxin®), and orphenadrine (Norflex®).
Antispasmodic agents, which are typically those used to treat symptoms associated with fibromyalgia, are generally prescribed along with rest, physical therapy, or other therapeutic measures in order to facilitate muscle relaxation and relieve pain. They are generally taken several times per day, and can have negative interactions with sedative medications, sleeping pills, tranquilizers, and certain vitamin supplements. The most commons side effects associated with antispasmodic medications include drowsiness, dizziness, upset stomach, clumsiness, headache, increased heart rate, upset stomach, vomiting, and nervousness. Serious allergic and adverse reactions may also occur to any of the antispasmodic medications listed above.
Although muscle relaxants are frequently mentioned as important components of a multidisciplinary approach to treating fibromyalgia (Han et al., 2011; Dussias et al., 2010), there is a lack of scientific evidence supporting their effects on fibromyalgia symptoms. Nevertheless, some studies have found that patients who take muscle relaxants report generalized improvement in symptoms (Tofferi et al., 2004; Vaeroy et al., 1989).
In addition to Lyrica (described above), which is often used as part of combined therapy to treat seizure disorders, another anti-seizure medication – gabapentin – is also commonly prescribed to treat nerve pain associated with diabetes, herpes, and shingles. Off-label, gabapentin has also been used to treat fibromyalgia and restless leg syndrome. Common trade names of gabapentin include Neurontin and Horizant. Gabapentin is available as a tablet, capsule, extended release capsule, or liquid, and each is prescribed differently, and doses vary from 900mg to 1,800 mg per day. Gabapentin can cause a number of unwanted side effects, including anxiety, depression, agitation, hostility, restlessness, mental or physical hyperactivity, and suicidal thoughts. Additional side effects include tingling, numbness, pain, muscle weakness, jaundice (yellowing of the skin), difficulty urinating, dark urine, confusion, cough, fever, rapid eye movements, blurred vision, and impaired thinking. Allergic reactions are also a possibility. In addition, the concurrent use of certain medications, such as antacids, opiate pain medications, and naproxen, can also lower the effectiveness of gabapentin.
With regard to the use of gabapentin in treating fibromyalgia, a 2007 study by Arnold et al. found improved pain among patients treated with gabapentin when compared to those who received a placebo. The researchers also found improved health status and sleep quality in the gabapentin-treated group (Arnold et al., 2007).
Common Prescription and Non-Prescription Pain Medications
Although fibromyalgia is not caused by inflammation, various non-steroidal anti-inflammatory agents (NSAIDs) may help ease the pain associated with many of fibromyalgia’s comorbid conditions, including headaches, joint pain, and myofascial pain. Common examples of NSAIDs include naproxen (Aleve, Naprosyn), ibuprofen (Advil, Motrin), and aspirin. It is important to use caution when using these medications, all of which are available in prescription-strength and over the counter versions. They can cause stomach upset and damage to the intestines, and may interfere with blood-thinning medications.
The most powerful type of prescription pain relieving medications available are known as opioids. Common examples of opioid pain medications include fentanyl (Actiq, Fentora, Duragesic), hydrocodone (Vicodin), morphine (Avinza, Kadian, Roxanol), and oxycodone (Oxycontin, Percolone). Although they can be initially beneficial to individuals who deal with chronic pain, they are not ideal choices for fibromyalgia-related pain, nor are they recommended for use by any currently-accepted fibromyalgia management guidelines (Carville et al., 2008; Hauser et al., 2010; Fitzcharles et al., 2011; Ngian et al., 2011). Nevertheless, many fibromyalgia patients take opioid pain medications at some point in their therapy, either for the legitimate treatment of coincidental acute pain conditions, or out of a sense of frustration for the lack of available effective therapies.
Opioid pain medications can cause a great number of serious side effects, including constipation, dizziness, lightheadedness, drowsiness, nausea, vomiting, dry mouth, and difficulty urinating. In addition, serious and permanent liver damage can also result, and severe allergic reactions are also possible. Individuals who consume too large of a dose run the risk of overdose, and the effects of opioids can be intensified by concurrent use of alcohol, tranquilizers, sleeping medications, certain antidepressant medications, and antihistamines. Furthermore, opioids are highly addictive, and tolerance to their effects on pain may also develop. It has also been demonstrated that the long term use of opioid pain medications can lead to the medications losing their effectiveness. Long term use has been shown to cause the body to change its response to the medications such that they can actually promote pain rather than serve as an effective treatment.