Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury
Open accessAbstract
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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The underlying neuropathology of posttraumatic sleep-wake disturbances remains little understood, and treatment options are limited.
“Over the last decade, researchers have developed a better clinical understanding of posttraumatic sleep-wake disturbances, but the underlying neuropathology remains little understood, and treatment options are limited.2,3”
From Damage to Arousal-Promoting Brainstem Neurons with Traumatic Brain Injury (2016) · cites this paper as [3]
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- Authors
- Kaiser, P. R., Valko, P. O., Werth, E., Thomann, J., Meier, J., Stocker, R., Bassetti, C. L., & Baumann, C. R.
- Affiliations
- University Hospital Zurich (CH)
- Venue
- Neurology
- Published
- 2010-11-16
- Volume
- 75
- Issue
- 20
- Pages
- 1780-1785
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- OpenAlex
- W2036038081
- Cited by
- 150
- References
- 23
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 10 · 2023: 3 · 2022: 10 · 2021: 9 · 2020: 9 · 2019: 12 · 2018: 14 · 2017: 9 · 2016: 8 · 2015: 9 · 2014: 13 · 2013: 13 · 2012: 13
- FWCI
- 7.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich)
- Topics
- Health Sciences › Medicine › Epidemiology › Traumatic Brain Injury Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Keywords
- modafinil, traumatic brain injury, excessive daytime sleepiness, wakefulness-promoting drugs, maintenance of wakefulness test, Epworth Sleepiness Scale, Fatigue Severity Scale, actigraphy, polysomnography, psychomotor vigilance test, drug tolerability
- MeSH terms
- Modafinil, Adult, Aged, Benzhydryl Compounds, Brain Injuries, Double-Blind Method, Fatigue, Female, Humans, Disorders of Excessive Somnolence, Male, Middle Aged, Narcolepsy, Pilot Projects, Placebos, Prospective Studies, Sleep Apnea Syndromes, Sleep Stages, Sleep Disorders, Circadian Rhythm
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