Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury
Abstract
Background:
Excessive daytime sleepiness (EDS) and fatigue are common symptoms after traumatic brain injury (TBI), but there is no specific treatment for affected patients. With this pilot study, we aimed at studying the effect of daily modafinil on posttraumatic EDS and fatigue.
Methods:
We conducted a prospective, double-blind, randomized, placebo-controlled pilot study in 20 patients with TBI who had fatigue or EDS or both. After baseline examinations (questionnaires including the Epworth Sleepiness Scale to assess EDS and the Fatigue Severity Scale to assess fatigue, actigraphy, polysomnography, maintenance of wakefulness test, and psychomotor vigilance test), 10 patients received 100 to 200 mg modafinil every morning, and 10 patients were treated with placebo. After a 6-week treatment period, all examinations were repeated.
Results:
EDS improved significantly in patients with TBI who were treated with modafinil, compared with the placebo group. Similarly, the ability to stay awake on the maintenance of wakefulness test improved only in the modafinil group. Modafinil, however, had no impact on posttraumatic fatigue. Clinically relevant side effects were not observed.
Conclusion:
This study indicates that modafinil is effective and well tolerated in the treatment of posttraumatic EDS but not of fatigue.
Classification of evidence:
This study provides Class I evidence that modafinil (100–200 mg daily) improves posttraumatic EDS compared with placebo. This study provides Class I evidence that modafinil (100–200 mg daily) does not improve posttraumatic fatigue compared with placebo.
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Copyright © 2010 by AAN Enterprises, Inc.
Publication History
Received: January 17, 2010
Accepted: August 2, 2010
Published online: November 15, 2010
Published in print: November 16, 2010
Disclosure
Dr. Kaiser, Dr. Valko, Dr. Werth, Ms. Thomann, and Ms. Meier report no disclosures. Prof. Stocker has served on scientific advisory boards for KCI Europe Holding BV and Baxter International Inc.; has received funding for travel or speaker honoraria from Fresenius Medical Care and Bio-Synthesis Inc.; and receives research support from the Swiss National Foundation, SUVA Foundation, the Swiss Academy for Medical Sciences, and Swisstransplant. Prof. Bassetti serves as Chief Editor of the Swiss Archives of Neurology and Psychiatry and on the editorial boards of the Journal of Sleep Research, Sleep Medicine, Somnology, and the Belgian Neurological Journal; has served on scientific advisory boards for and received speaker honoraria from Boehringer Ingelheim, Lundbeck Inc., Novartis, Pfizer Inc, ResMed Inc., and UCB; receives research support from Lundbeck Inc., Respironics, Inc., ResMed Inc., Vifor Pharma, and UCB; and receives institutional research support from the Zurich Center for Integrative Human Physiology and the Swiss National Science Foundation. Dr. Baumann has served on scientific advisory boards for and received speaker honoraria from Boehringer Ingelheim, UCB, and GlaxoSmithKline; receives research support from UCB, Cephalon, and Novartis; and receives institutional research support from the Swiss National Foundation.
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Statistical analyses were performed by Christian R. Baumann.
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