Best medications to treat fibromyalgia

The symptoms of fibromyalgia include widespread pain and tenderness along with other problems, including depression, difficulty sleeping, fatigue, and irritability. The symptoms can interfere with a person’s life at work and at home.

Because there is not a single, specific cause of fibromyalgia and the symptoms can vary from patient to patient, choosing an effective treatment can be challenging. Experts say the best, overall strategy includes medications and nondrug therapies, such as exercise, counseling, and stress relief.

The medications used to treat fibromyalgia include antidepressants (amitriptyline, nortriptyline, fluoxetine, paroxetine, duloxetine, milnacipran), a few anti-seizure medications (gabapentin, pregabalin), and a muscle relaxant (cyclobenzaprine). But studies show that the benefits of these medications are generally small. There is no clear evidence that one drug is better than another, and all of them probably lose their benefit over time.

Each drug differs in the risks it poses to you. All antidepressants should be used with caution in those with a history of suicide attempt or who are at risk of suicide, especially in people 25 years old or younger. Amitriptyline, cyclobenzaprine, gabapentin, and pregabalin all cause increased sedation and should be used with caution in the elderly.

The medications differ substantially in price, so cost might be an important factor in determining which one you choose. The monthly cost for these drugs ranges from as little as $6 to more than $500.

Taking into account the evidence of their effectiveness and safety as well as their price, we have chosen three Consumer Reports Best Buy Drugs as initial options to consider if you and your doctor have decided that a medication is appropriate for your fibromyalgia symptoms:

• Generic amitriptyline
• Generic gabapentin
• Generic paroxetine-IR (immediate release)

All of these medications have been on the market for 15 years or more and have been widely used. They are all available as inexpensive generics and are at least as effective and safe as the other fibromyalgia medications.

Although side effects of sedation, dry mouth, and dizziness are common, serious side effects are rare.

The three drugs with FDA-approval for the treatment of fibromyalgia—pregabalin, duloxetine, and milnacipran—did not meet our Best Buy criteria because they are more expensive than our Best Buys, but have not been shown to be clearly more effective or safer.

The symptoms of fibromyalgia include pain and tenderness throughout the body that is often associated with other conditions that reduce a person’s ability to function and affects her quality of life. People with fibromyalgia often have difficulty sleeping, feel tired during the day, and experience irritability and depression, all of which can affect their life at work and at home.

Between 1 percent to 5 percent of adults in the U.S. have fibromyalgia, with women much more likely to develop it than men—about 80 to 90 percent of fibromyalgia sufferers are women. It can strike children and teens, but it’s more common in older adults, with most cases occurring between the ages of 40 and 70.

According to criteria established by the American College of Rheumatology, a person is considered to have fibromyalgia if she has unexplained, widespread pain and other symptoms such as fatigue, feeling unrefreshed after waking, and thought and memory problems for at least 3 months.

There are nine paired points on the body where fibromyalgia tenderness usually occurs:

• neck
• shoulders
• chest
• arms
• lower back
• legs

The cause of fibromyalgia is not known. So far, scientists have not found one specific cause, and some experts say they think the condition is probably due to many different factors. One possibility is that people with fibromyalgia appear to have a problem with their nervous system. The nerves that carry messages of pain continue to fire even when there is no injury or trauma, which makes them feel pain at times when other people would not—for example, when they are touched or hugged. It’s unclear whether the other symptoms—sleep problems, depression, anxiety, and stress—play a role in the cause of fibromyalgia, but they all may be part of the overall condition.

Because there is not one specific cause of fibromyalgia and the symptoms can vary from person to person, choosing an effective treatment can be challenging. Experts suggest that the best strategy includes medications and nondrug therapies, such as exercise, counseling, and stress relief. We don’t evaluate the nondrug strategies here.

We focus on 10 of the most commonly used medications to treat fibromyalgia. We review the evidence on how the medications compare to each other in their ability to relieve symptoms and the side effects they can cause. Our review is based on a comprehensive expert analysis of the medical evidence available on medications used to treat fibromyalgia.

Medications Evaluated in Our Analysis

Three of the drugs listed—duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica)—are approved by the FDA for the treatment of fibromyalgia. While the other drugs are approved for treating conditions associated with fibromyalgia, including depression and pain, they are not specifically approved for fibromyalgia. All of the antidepressant medications studied are FDA-approved for treating depression, with many also having FDA approval for treating pain. The antiepileptic gabapentin is also approved for treating nerve pain, while the muscle relaxant cyclobenzaprine is approved for treating muscular pain.

Although none of the 10 medications are approved for treating sleep disorders, some of them cause sedation and are often prescribed “off-label” to help with sleep. The term off-label means that the drug is prescribed to treat a condition other than what it was approved for by the FDA. Doctors can legally prescribe any medication they see fit to treat a person’s condition. It is important to note that although only these three drugs are approved by the FDA specifically for fibromyalgia, the approval process is long and expensive for manufacturing companies, so older drugs that are already approved for other uses might not be taken through this process.

In practice, often more than one medication is used to treat fibromyalgia, but there have been very few studies that evaluated the effectiveness of combination treatments. For this reason, we focus on the use of one medication at a time. You should know that the effectiveness of one drug may wane over time and that when this occurs, it is common to switch to another medication. But suprisingly, you may then later go back to the first medication and find it to be effective again.

There are other medications that have been used to treat the symptoms of fibromyalgia but they are not included in our analysis. The treatment approaches using those additional medications are quite diverse and include commonly used drugs such as nonsteroidal anti-inflammatory drugs, nausea medications, sedatives, pain medications such as opioids, and less commonly used medications such as growth hormone and synthetic cannabinoids. Most of those have not been studied well enough in the treatment of fibromyalgia to support conclusions about their use.

Each of those types of medications works differently in the body to relieve symptoms. This section will help you understand how they work and how they compare in terms of effectiveness and safety. It is important to note that few studies directly compare one drug to another and most of the studies were small and short term (most lasting less 15 weeks or less), which limits the strength of the overall evidence.

Antidepressants alter the level of chemicals in the brain called neurotransmitters. They are categorized based on their chemical structure and the neurotransmitters they affect—primarily serotonin and norepinephrine. Serotonin and norepinephrine appear to lessen the effects of the nerve fibers carrying messages of pain to the brain.

Some of these medications also cause sedation and seem to help a person sleep better. Improving sleep and depressive symptoms seems to strongly affect a person’s ability to concentrate, be less irritable, experience less pain, and feel better overall.

There are two serious but rare safety concerns you should be aware of if you take an antidepressant. Most of the antidepressants (and gabapentin) can increase the risk of suicidal thoughts and behaviors in children, teens, and young adults, so they should be used cautiously in people who are at risk of suicide.

In addition, most of the antidepressants discussed in this report—citalopram, duloxetine, fluoxetine, milnacipran, and paroxetine—and some of the other drugs used to treat fibromyalgia (for example, Tramadol) can increase the levels of the brain chemical serotonin. If the level of serotonin becomes too high in the body, it can cause a condition called serotonin syndrome, which is a medical emergency. The condition causes confusion, increased heart rate, shivering, sweating, high blood pressure, very high fevers, and muscle twitching and tremors. If this happens, contact your doctor immediately.

Certain medications, including migraine medications and some sleep aids, increase the risk of serotonin syndrome when taken with antidepressants, so make sure your health care provider is aware of any other medications you are taking. Neither suicide nor serotonin syndrome was reported in the studies of fibromyalgia.

In general, people with fibromyalgia who take tricyclic medications experience a greater reduction in pain than those taking no medication.

Amitriptyline is the most well studied of the tricyclics, yet it is not clear exactly how many patients with fibromyalgia experienced meaningful pain relief from taking it. The best estimate is that one of every four patients benefit from it. On average, people with fibromyalgia who took amitriptyline reported that their pain improved by almost two points on a 10-point scale compared to those who took a placebo. Studies that have taken into account factors such as how fibromyalgia was diagnosed and the form of amitriptyline used (long-acting vs short-acting, for example) have not found the same benefit, so our confidence in this result is low. There is not enough evidence to say how well amitriptyline compares to placebo on other outcomes, including fatigue and function.

The use of nortriptyline in fibromyalgia patients has been studied in a single trial, but the results were inconclusive, partially because a low dose of the drug was used.

Side effects of the tricyclic antidepressants can include dizziness, dry mouth, gait disturbances, sedation and stomach upset. More serious side effects include heart arrhythmias and seizures, but those were not reported in patients taking these medications for fibromyalgia.

In the low doses commonly used for fibromyalgia, side effects appear minimal and do not usually seem to cause people to stop using the medication.

Duloxetine and milnacipran relieve pain. In studies, pain was reduced by half in 30 out of 100 people taking duloxetine or milnacipran, compared with 20 out of 100 people taking placebo. Duloxetine was superior to milnacipran in improving average pain score, symptoms of depression, sleep disturbances, and general quality of life in the short term—less than six months. But over time, the differences were negligible.

Side effects are common with both drugs and include constipation or diarrhea, dizziness, dry mouth, headache, increased sweating, and stomach upset. Both drugs have also been associated with increased liver enzymes. In clinical trials, milnacipran increased heart rate in some patients whereas duloxetine did not. Both drugs were similar in the rate of people who stopped taking the drug due to side effects.

These medications are not well studied in patients with fibromyalgia but the available evidence indicates that immediate-release paroxetine may provide a small improvement in pain, sleep, and depression based on one trial comparing paroxetine to amitriptyline. We can’t draw conclusions about the effectiveness of fluoxetine and citalopram for treating fibromyalgia symptoms due to the small sizes of the available studies (51 people or less) and the quality of the study designs.

The common side effects of these medications include drowsiness, dry mouth, and sexual dysfunction.

Although a small number of patients in clinical trials stopped their medication because of these side effects, these drugs are generally well tolerated.

Gabapentin and pregabalin are classified as antiseizure medications, but they are also used to help relieve pain in people with fibromyalgia. Both medications alter the brain chemistry. Pregabalin decreases levels of chemicals in the brain called neurotransmitters that build up because of the constant firing of the nerves in the spinal cord and the brain. It also increases other neurotransmitters that help suppress the constant firing of the nerves, which helps relieve pain. It’s unclear which neurotransmitters are affected by gabapentin or pregabalin.

Both drugs improve pain, sleep, fatigue, and the quality of life in people with fibromyalgia to about the same degree as amitriptyline. In clinical trials, 70 percent of people with fibromyalgia who took gabapentin for 12 weeks said they felt better compared with 40 percent of those who took a placebo. In addition, 51 percent of those who took gabapentin experienced a reduction of one-third in their pain compared with those who took a placebo.

In another trial, between 40 percent and 80 percent of people who took pregabalin said their pain was reduced by nearly a third, compared with 28 percent to 38 percent of those who took a placebo. For doses of 300 mg to 600 mg per day of pregabalin, 20 percent to 24 percent of patients said their pain was reduced by half compared with 12 percent of patients taking placebo.

One of the most common side effects of pregabalin and gabapentin is sedation. This is why they are often given at higher doses at night, which seems to help with sleep. Other side effects can include confusion, blurred vision, dizziness, liver and kidney impairment, and problems with concentration. In particular, they should be used with caution in elderly people due to side effects of confusion, dizziness, and sedation. Both drugs can also cause swelling, so people with heart failure should not take them. Gabapentin has been shown to increase the risk of suicide in depressed people and should be avoided in those at increased risk of suicide attempt.

The following table summarizes the drugs that provide an overall improvement in fibromyalgia based on measures of many symptoms including function, pain level, fatigue, sleep disturbance, and psychological distress.

Drugs Providing Generalized Relief of Fibromyalgia Symptoms

Studies show that most of these medications reduce pain to a similar degree. Although some studies suggest that some drugs are more effective than others for a given symptom, there is no clear evidence overall that one drug is better than another. All probably lose their benefit with time.

Few studies have compared one drug directly to another. Duloxetine and pregabalin have been shown to be superior to milnacipran in improving sleep problems and quality of life, while duloxetine and milnacipran have been shown to be superior to pregabalin in the treatment of depression.

There are no significant differences in overall improvement in pain symptoms among these drugs. A meta-analysis of all the available data found that none of the medications was clearly superior.

There are no differences among the drugs in the percentage of people who stop taking them for any reason or in the percentage who stop taking them specifically due to adverse events. Serious side effects are rare, although all of the antidepressants and gabapentin have the potential to increase the risk of a suicide attempt and many of the medications also pose a risk of serotonin syndrome. See the table below for the most common side effects and rare but serious side effects associated with these medications.

Close monitoring is necessary to avoid side effects and interactions with other medications, and no medication should be stopped abruptly. Also, avoid alcohol or other sedating drugs while taking any of these medications.

All the medications should be used at the lowest possible dose that provides improvement in your fibromyalgia symptoms.

Possible Side Effects of the Fibromyalgia Drugs

Antidepressants, antiseizure medications, and muscle relaxants can play a role in the treatment of fibromyalgia, but the benefits are generally small. There is no clear evidence that one drug is better than another, and all of them are likely to lose their benefit with time. Although we did not evaluate other fibromyalgia treatments such as exercise, counseling or stress-relief, incorporating those into any treatment program is a recommended approach by our medical experts.

In terms of the medications, side effects are also important to consider. While none of the drugs are clearly safer than the others, each drug differs in the risks it poses to you (as we have described in table above).

The medications differ substantially in price, so cost might be an important factor in determining which one you choose. As you can see from the cost table below, some generic prescription versions cost as little as $6 for a month’s supply, while more expensive brand names can run $500 or more monthly. Since none of the medications have been shown to be clearly more effective than the others, it makes sense to start with the least expensive option, if you have decided a medication is worth a try.

In terms of cost, generic formulations of some of those medications can run as little as $4 for a month’s supply through generic drug programs run by major chain stores such as Kroger, Sam’s Club, Target, and Walmart. For an even better bargain, you may be able to get a three-month supply for $10. We note in the price chart below which generics are likely to be available through these programs. Some stores, such as CVS and Walgreens, may require a membership fee to take part and might charge higher prices. There might be other restrictions too, so check the details carefully to make sure your drug and dose are covered.

Taking into account the evidence on their effectiveness and safety as well as their price, we have chosen three Consumer Reports Best Buy Drugs as initial options to consider if you and your doctor have decided a medication is appropriate for your fibromyalgia symptoms:

• Generic amitriptyline
• Generic gabapentin
• Generic paroxetine-IR (immediate release)

All of these medications have been on the market for 15 years or more and have been widely used by doctors. They are all available as inexpensive generics (compared to the costs of brand name drugs) and are at least as effective and safe as the other fibromyalgia medications.

Although side effects of dizziness, dry mouth, and sedation are common, serious side effects are rare and percentage of people who stop using these medications due to adverse effects are similar to placebo.

The three drugs with FDA-approval for the treatment of fibromyalgia—pregabalin, duloxetine, and milnacipran—did not meet our Best Buy criteria. They are more expensive than our Best Buys but have not been shown to be clearly more effective or safer.

Our evaluation is primarily based on an independent scientific review of the evidence on the effectiveness, safety, and adverse effects of the drugs included in this report. A team of physicians and researchers at Oregon Health & Science University Evidence-based Practice Center conducted the analysis as part of the Drug Effectiveness Review Project, or DERP. DERP is a first-of-its-kind multistate initiative to evaluate the comparative effectiveness and safety of hundreds of prescription drugs.

A synopsis of DERP’s analysis of the drugs to treat fibromyalgia forms the basis of this report. A consultant to Consumer Reports Best Buy Drugs is also a member of the Oregon-based research team, which has no financial interest in any pharmaceutical company or product.

The monthly drug costs we cite were obtained from a health-care information company that tracks the retail sales of prescription drugs in the U.S. Prices for a drug can vary quite widely, even within a single city or town. All the prices in this report are national averages based on sales of prescription drugs in retail outlets. They reflect the cash price paid for a month’s supply of each drug in January 2014.

Consumer Reports Best Buy Drugs selected the Best Buy Drugs using the following criteria. The drug had to:

-Be as effective as or more effective than other medicines used to treat fibromyalgia.

-Have a safety record equal to or better than other medicines used to treat fibromyalgia.

-Have an average price for a 30-day supply that was substantially lower than the most costly medication meeting the first two criteria.

The Consumers Reports Best Buy Drugs methodology is described in more detail in the Methods section at www.CRBestBuyDrugs.org.

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These materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

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