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Dr. Thomas L. Schwartz presented the findings of a study he conducted on the drug with his associate, Dr. Susan M. Chlebowski of SUNY Upstate in Syracuse, New York, at the American Psychiatric Association's 2006 annual meeting in Toronto on May 22nd. The researchers performed a medical history case review on 98 Fibromyalgia patients who also happened to be receiving Modafinil at dosages ranging from 200 to 400 mg/day.

The patients had an average initial baseline score of 7 out of 10 on the visual-analog rating scale, which indicates a high level of fatigue. After treatment with Modafinil began, the scores fell into the 3-4 range, indicating substantial improvement in fatigue symptoms. Two-thirds of the patients showed improvement with Modafinil, while one-third showed no benefits.

As with any prescription drug, there can be side effects with modafinil, which typically include headache, dizziness, and nervousness. It may also interfere with the functioning of birth control pills, so women on the drug may need an alternate or second system for birth control. Classed as a low-level controlled substance with a mild potential for addiction, physicians will want to carefully monitor their patients during treatment, especially if past substance abuse issues are in the patient history.

Fibromyalgia, which affects predominately women in their middle years, has no officially accepted cause and no generally accepted cure or treatment. It is commonly treated with a combination of therapies, which may include prescription drugs, nutrition, dietary supplements, exercise or physical therapy, psychotherapy, behavior therapy, biofeedback, meditation, acupuncture and other treatment options.

Because modafinil is a prescription drug with stimulant effects and potential serious side effects, and because use of the drug for fatigue in Fibromyalgia is an “off-label” or non-reviewed use under Food and Drug Administration (FDA) standards, it should be used with care and only under close physician supervision.