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Modafinil in fibromyalgia treatment.

Schaller JL, Behar D.

County Research Center, West Chester, PA and Eastern Pennsylvania Psychiatric Institute, Philadelphia, PA
J Neuropsychiatry Clin Neurosci 2001 Fall;13(4):530-1


Modafinil has shown benefits in fatigue-related disorders such as multiple sclerosis and various forms of neurological fatigue.1,2  We report the successful use of modafinil for fibromyalgia (FM) fatigue in 4 patients in an open study with naturalistic on-off experiences. A rheumatologist and another physician confirmed each diagnosis of fibromyalgia.

Fibromyalgia  affects 2% of the population and is characterized by chronic musculoskeletal pain (especially at characteristic soft-tissue trigger sites); severe fatigue, typically lasting >24 h with minimal activity; nonrestorative sleep; and mood abnormalities.35 The American College of Rheumatology adds the criterion of widespread pain for 3 months with tenderness in at least 11 of 18 specific trigger-point sites.6

We excluded 2 patients for comorbid secondary major depression (MD) until they went into full remission on their antidepressants, confirmed by two MD research scales, to remove the variable of modafinil antidepressant augmentation.7,8

All patients had physical exams and laboratory testing excluding Lyme disease, Ehrlichia equi and E. chaffeensis, Babesia microti, rheumatoid or spinal arthritis, major sleep disorders, and abnormal cervical and brain MRIs.

After an average 18 months of medical care, they found minimal relief. None could stay awake 16 hours on 3 consecutive days, shop routinely, provide basic childcare, drive over an hour per day, balance a checkbook, maintain a 30-hour work week, or cook routinely. Patient expectations for relief from this trial were very low because of past failures.

Two fibromyalgia patients reported some beneficial effects of depression on day one at 100 mg q A.M., which were nevertheless incomplete. Weekly dose adjustments upward in 50-mg increments and the addition of an afternoon dose met with reports of highly significant benefit by all patients.  After titration adjustments were finalized over 3 weeks, all reported a sustained increase in functional capacity. Global Assessment of Functioning average improvement was a change from 55 to 70; that is, from moderate impairment to minimal impairment.

All patients had a strong desire to continue their treatment because they now reported being "functional," able to work or to care for their children.  Fatigue improved; all patients reported highly significant improvement in alertness and a reduced need for disruptive naps. They received unsolicited comments about their improvement from their children, spouses, employers, or parents, who were unaware of the modafinil trial.  Benefits persisted over 3 continuous months at the same dose.

Alertness benefits were lost if a breakfast modafinil dose was skipped.  Benefits returned quickly the following day if modafinil was restarted.  Each patient missed at least 2 days of medication because of forgotten doses or a lost prescription. They reported a full return of fatigue and impairment that day. These mishaps represent naturalistic "on-off" experiments, supporting the immediate efficacy of modafinil.  This immediate effect contrasts with our clinical expectations of gradual benefits.

The mean dose was 250 mg per day with a range of 150 to 300 mg. Patients took a dose of 150200 mg in the morning, and half of them took an extra 50 mg or 100 mg in the early afternoon.  One patient reported slight anxiety during week one, which resolved with a 50-mg dose reduction.  We experienced inconclusive results in 3 patients, not included in our report, who dropped out or were lost to follow-up for reasons such as relocation.

The fatigue of fibromyalgia causes marked impairment and has no definitive single treatment.  Modafinil is a potential treatment option worthy of larger clinical trials.

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Rammohan KW, Rosenberg JH, Pollak CP, et al: Provigil (modafinil): efficacy for the treatment of fatigue in patients with multiple sclerosis. Neurology 2000; 54:A24

Cochran JW: Effect of modafinil on fatigue associated with neurological illnesses. J Chronic Fatigue Syndrome 2001; 8:65-70

Matsumoto P: Fibromyalgia syndrome. Nippon Rinsho 1999; 57:364-369

Cathebras P, Lauwers A, Rousset H: Fibromyalgia: a critical review. Ann Med Interne (Paris) 1998; 149:406-414

White KP, Speechley M, Harth M, et al: The London fibromyalgia epidemiology study: the prevalence of fibromyalgia syndrome in London, Ontario. J Rheumatol 1999; 26:1570-1576[Medline]

Wolfe F, Smythe HA, Yunus MB, et al: The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the multicenter criteria committee. Arthritis Rheumatol 1990; 33:160-172

Menza MA, Kaufman KR, Castellanos A: Modafinil augmentation of antidepressant treatment in depression. J Clin Psychiatry 2000; 61:378-381[Medline]

DeBattista C, Solvason HB, Kendrick E, et al: Modafinil as an adjunctive agent in the treatment of fatigue and hypersomnia associated with major depression. New Research Program and Abstracts, American Psychiatric Association 154th Annual Meeting, May 9, 2001, New Orleans, LA. Abstract NR532:144.

 1.   Modafinil  augmentation of antidepressant treatment
 2.   Modafinil  children with attention-deficit/hyperactivity disorder
 3.   Modafinil  in fibromyalgia treatment
 4.   Modafinil  efficacy in narcolepsy
 5.   Modafinil  narcolepsy: symptoms and management
 6.   Modafinil  successful treatment of hypersomnia & narcolepsy
 7.   Modafinil  drug of choice for narcolepsy
 8.   Modafinil  in the treatment of narcolepsy
 9.   Modafinil  effect on narcolepsy
10.  Modafinil  a narcolepsy study
11.  Modafinil  switching from narcolepsy drugs to modafinil
12.  Modafinil  and naps as counter measures in sleep deprivation
13.  Modafinil  as a treatment for excessive daytime sleepiness
14.  Modafinil  use in a sleep deprivation experiment
15.  Modafinil  excessive sleepiness in Parkinson's disease
16.  Modafinil  the unique properties of a new stimulant 
17.  Modafinil  for sustaining the alertness of helicopter pilots
18.  Modafinil  dosage and safety
19.  Modafinil  treatment of alcoholic organic brain syndrome
20.  Modafinil  effect on melatonin, cortisol, and growth hormone
21.  Modafinil  in obstructive sleep apnea-hypopnea syndrome
22.  Modafinil  vs dextroamphetamine in treatment of adult ADHD
23.  Modafinil  dopaminergic transmission mediates CNS stimulants
24.  Modafinil  for daytime sleepiness in sleep apnea
25.  Modafinil  treatment of residual excessive daytime sleepiness
26.  Modafinil  amplification of cortical serotonin release
27.  Modafinil  for the treatment of multiple sclerosis

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