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Medically reviewed by P. Thornton, DipPharm Last updated on Feb 13, 2018.

Fibromyalgia is a long-term condition that affects three to six million people in the US each year (source), particularly women. People with fibromyalgia have widespread pain that may be difficult to pin-point. They usually have sleep problems and feel tired - sometimes to the extent of not being able to work.

A number of different medicines have been studied in fibromyalgia. Unfortunately usually only small benefits are seen. Until recently, no medicine had fibromyalgia as a use approved by the FDA. However, Lyrica became licensed for this indication in June 2007, a first for the US. Studies show that for some people with fibromyalgia, Lyrica may reduce symptoms. At least as important as medicines are exercise, cognitive behavioral therapy (changing thought patterns) and education.

Page Contents

Summary of treatment options

References: Busch, 2002; Pfizer Lyrica Product Label, June 07 - from FDA website; Goldenberg, 2004

Treatment Usage How effective Common side effects
Lyrica (pregabalin) capsules
Prescription only.
Take twice daily, start low and gradually increase if necessary to a maximum of 225mg twice a day.
  • It's a bit better than placebo (dummy tablets) but quite a lot of people with fibromyalgia don't see any benefit, and those who do benefit don't get rid of fibromyalgia symptoms completely.
  • In one study 68% of those using 300mg daily and 78% of those using 450mg daily noticed some improvement. But so did 48% of people taking placebo (inactive tablets). And a third of patients given Lyrica dropped out of the study.
  • In the same study about a third of patients on Lyrica had a 30% or better improvement in pain. Around 25% of placebo patients had a 30% or better improvement in pain. So Lyrica is a bit better than placebo.
  • Dizziness (38%) Sleepiness (20%)
  • Increased weight (11%)
  • Blurred vision
  • Dry mouth
  • Constipation
  • Fatigue
  • Swelling in extremities (edema)
  • Euphoric mood
  • Increased appetite
  • Disturbed attention
  • Balance disorder
Exercise Muscle strengthening and/or aerobic exercise helps reduce pain and improve functioning.
  • Can reduce pain, help mood, reduce tiredness, increase ability to do things and improve overall well-being.
  • Need to keep doing the exercise to be effective.
  • Initially stiffness can occur, so start at a low level and gradually increase. Check with your doctor before starting an exercise programme
Cognitive Behavioral Therapy This therapy gives pain coping skills, helps with stress and helps manage negative thoughts.
  • Modest benefit in many patients, helping pain, tiredness, mood and functioning.
Patient education Provides information often in a group, e.g. by attending lectures.
  • May help depression and pain.
Combination Use a variety of strategies together, e.g. medicine, exercise and education or cognitive behavioral therapy.
  • This is likely to give the best results.
  • As above

Is fibromyalgia real?

Because the symptoms can be vague and there's no obvious cause, doctors and patients can sometimes wonder if it is a real illness. But there is proof that it is real. Brain imaging studies have shown a difference in the way the brain processes pain messages (Clauw, 2003*). Substance P, a chemical in the body that increases awareness of pain, is increased in the spinal fluid in people with fibromyalgia (Goldenberg, 2004). Serotonin, a chemical in the brain that affects mood, sleep, appetite, among other things, is usually low in fibromyalgia. There are even changes seen in capillaries (Morf, 2005).

Fibromyalgia can make it harder to work and has an impact on other areas of life.

How is fibromyalgia diagnosed?

The American College of Rheumatology produced criteria in 1990 for diagnosis of fibromyalgia (ref: Wolfe, 1990). Patients must have:

  • History of widespread pain, and
  • Pain at 11 or more of 18 tender points when touched in a certain way

Symptoms of fibromyalgia

Common symptoms include:

  • Widespread pain
  • Difficulties sleeping or waking from sleep in the morning feeling tired
  • Fatigue
  • Stiffness

People with fibromyalgia may also experience:

  • Depression
  • Anxiety
  • Irritable bladder
  • Irritable bowel
  • Tingling, burning or other sensations on the skin
  • Restless legs
  • Difficulty concentrating/memory difficulties
  • Headaches
  • Intolerance to cold
  • Raynaud’s syndrome
  • Muscle weakness

(Rooks, 2007, Goldenberg 2004, Morf 2005 Anonymous, 2003. Minerva. BMJ 2003; 327: E27: E136; Wolfe 1995)


Unfortunately fibromyalgia is difficult to treat. There is no cure that makes it go away forever. There is nothing to take away the symptoms completely. The best that can be done is improving pain and functioning to make a person with fibromyalgia feel better and be able to do day-to-day activities better.


A number of medicines and remedies have been researched for fibromyalgia, but usually benefits are small. Doctors often prescribe medicines for fibromyalgia that aren't licensed for this use. To be licensed, the FDA has to approve it after the manufacturer of a medicine gives them evidence that it works.

Lyrica has recently been licensed for use in fibromyalgia - a first in the US. While Lyrica will help some patients with fibromyalgia, for many it won't help at all or will only help a little bit (ref: Pfizer Lyrica Product Label, June 07 - from FDA website).

Common pain relievers such as anti-inflammatories (e.g. ibuprofen, naproxen), acetaminophen and codeine or related medicines generally don't help in fibromyalgia (Goldenberg, 2004, O'Malley, 2000), although sometimes they might be a useful add-on to other treatment (Buckhardt, 2005).

Examples of medicines used "off-license" include antidepressants, particularly amitriptyline, cyclobenzaprine, fluoxetine and venlafaxine (ref: Goldenberg, 2004, Buckhardt, 2005). "Off-license" means that these medicines are not approved for this use by the FDA. These medicines have shown some benefit in trials, although sometimes the trials are only over a short period. A group of doctors looked at a number of studies of antidepressants in fibromyalgia (O'Malley, 2000). They found that antidepressants are beneficial, but still antidepressants don't work for everyone with fibromyalgia - for every four people taking the antidepressant, one improved. Many people with fibromyalgia are prescribed an antidepressant. Antidepressant medicines such as amitriptyline are often used in much lower doses than the dose for depression.


Lyrica is a capsule used for epilepsy, pain following shingles, and nerve pain in people with diabetes. It contains a medicine called pregabalin. Lyrica was first approved by the FDA in 2005, and in June 2007 was approved for fibromyalgia. In the US Lyrica is only available on prescription.

How does Lyrica help in fibromyalgia?

It really isn’t known. Other medicines that help in epilepsy have been found to work in pain like fibromyalgia where the pain seems to come from a problem of the pain message rather than damage to muscles or joints.

How effective is Lyrica?

Lyrica helps reduce the symptoms in some people with fibromyalgia. It’s not a magical cure - many people with fibromyalgia will notice only a small improvement, or none at all. For those who do have an improvement, the pain won't go completely, but the improvement may be enough to help that person manage better in their work or home life. In one study 68% of people given 300mg daily and 78% of those using 450mg daily noticed some improvement in their symptoms (Pfizer, 2007). But so did 48% of people taking placebo (inactive tablets). And a third of patients given Lyrica dropped out of the study.
In the same study about a third of patients on Lyrica had a 30% or better improvement in pain. Around 25% of placebo patients had a 30% or better improvement in pain. So Lyrica is a bit better than placebo.

What side effects does Lyrica have?

Nearly 20% of Lyrica patients in a fibromyalgia trial stopped taking it because of side effects (Pfizer, 2007), but some patients were taking a higher dose than is now recommended. Dizziness and sleepiness are the most common side effects to cause people to stop taking Lyrica (Blommel, 2007).

Controlled drug

Pregabalin the ingredient in Lyrica is a Schedule V controlled substance. Lyrica can cause euphoria in a small number of patients (4%), but it isn’t continued with ongoing use of the medicine (Blommel, 2007). When pregabalin has been stopped suddenly in studies, some patients have had difficulty getting to sleep, upset stomach, headache and diarrhoea (Blommel, 2007). One author noted it was that this problem had been seen only in generalized anxiety disorder studies (Shneker, 2005).

View more information on Lyrica: Consumer | Professional

History of pregabalin

Pregabalin was initially developed by biochemist Richard Silverman at Northwestern University in the United States. Pregabalin received U.S. Food and Drug Administration (FDA) approval for use in treating epilepsy, diabetic neuropathy pain and post-herpetic neuralgia pain in June 2005, and appeared on the U.S. market in fall 2005. In 2007 it was the first medicine in the US to become approved for use in fibromyalgia. (ref: Wikipedia, accessed Sep 07)

View more information on pregabalin: Consumer | Professional

Other treatments

The following non-medicinal treatment has evidence for being effective in fibromyalgia (Goldenberg, 2004, Gowans, 2004, Richards & Scott, 2002)

  • Exercise and/or strength training
  • Cognitive Behavioral Therapy
  • Patient education
  • Acupuncture (some studies suggest no benefit, ref: Rooks, 2007)
  • Hypnosis
  • Relaxation techniques


Many people with fibromyalgia don't do much exercise (Busch, 2002), and may worry that doing exercise will make them worse. However studies show that many people with fibromyalgia have clear improvements from exercise. Stiffness may follow the exercise when first starting, but should soon go.

Aerobic exercise is exercise such as biking, walking, swimming and aerobics. Studies of aerobic exercise in people with fibromyalgia shows pain and tiredness are reduced, sleep is improved and people think they’re able to function better (ref: Busch 2002, Rooks, 2007). Aerobic exercise is also good for the heart and weight.

One small study of twice-weekly strength training found improvements in pain, depression, tiredness and general health (Hakkinen A, 2001). It found women with fibromyalgia could gain as much muscle strength as women without fibromyalgia going through the same strength training. So fibromyalgia doesn’t stop muscles from being responsive to exercise.

The American Pain Society Guideline (Burkhardt, 2005) recommends starting with levels of exercise just below what the person is able to do and gradually increasing. It recommends moderate intensity aerobic exercise two to three times per week, and muscle strengthening two times per week.

Always check with your doctor before starting on an exercise programme.

Cognitive behavioral therapy

This therapy works on thought patterns, trying to get rid of negative thoughts and destructive behavior. It helps in dealing with stress and negative emotions that can make fibromyalgia worse. A psychotherapist has sessions for individual patients. This therapy can help pain, depression, tiredness and function in people with fibromyalgia (Goldenberg, 2004).

Additional resources:


  • Anonymous. Minerva. BMJ 2003; 327: E27: E136
  • Blommel ML, Blommel AL. Pregabalin: an antiepileptic agent useful for neuropathic pain. Am J Health-Syst Pharm 2007; 64: 1475-82.
  • Buckhardt CS, et al. Guideline for the management of fibromyalgia syndrome pain in adults and children. Glenview (IL): American Pain Society (APS); 2005. 109 p. (Clinical practice guideline; no. 4).
  • Busch AJ, et al. Exercise for treating fibromyalgia syndrome. Cochrane Database of Systematic Reviews 2002, Issue 2
  • Clauw D. Editorial. The health consequences of the first Gulf war. BMJ 2003;327:1357-1358
  • Goldenberg D L, et al. Management of fibromyalgia syndrome. JAMA 2004; 292: 2388-95.
  • Gowans SE, deHueck A. Effectiveness of exercise in management of fibromyalgia. Curr Opin Rheumatol 16(2):138-142, 2004
  • Hakkinen A, et al. Strength training induced adaptations in neuromuscular function of premenopausal women with fibromyalgia: comparison with healthy women. Ann Rheum Dis 2001; 60: 21-6.
  • Luedtke CA et al. A description of a brief multidisciplinary treatment program for fibromyalgia. Pain Manag Nurs.  2005;6(2):76-80.
  • Morf S, et al. Microcirculation abnormalities in patients with fibromyalgia - measured by capillary microscopy and laser fluxmetry. Arthritis Res Ther. 2005; 7 (2): R209-R216.
  • O'Malley PG, et al. Treatment of Fibromyalgia with Antidepressants. A Meta-analysis. Journal of General Internal Medicine 2000; 15: 659-666.
  • Pfizer. Lyrica Product Label, June 07.
  • Richards SCM, Scott DL. Prescribed exercise in people with fibromyalgia: parallel group randomized controlled trial. BMJ 2002; 325: 185.
  • Rooks DS. Fibromyalgia Treatment Update. Curr Opin Rheumatol. 2007;19(2):111-117.
  • Shneker BF, McAuley JW. Pregabalin: a new neuromodulator with broad therapeutic indications. Ann Pharmacother 2005; 39: 2029-37.
  • Wolfe F, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Arth Rheum 1990; 33: 160-72.
  • Wolfe F, et al. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 1995; 38: 19-28.

Further information

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