Provigil (modafinil) is FDA approved for excessive sleepiness due to various causes. An ADHD indication was rejected because of its possible association with a single case of Stevens-Johnson syndrome. Nonetheless, Provigil enjoys wide use for off-label indications, including medica- tion-associated fatigue, augmentation of antidepressants, and as a pick-me-up for the frazzled and exhausted 21st-century human. A group of researchers at Vanderbilt University has recently reported on the effects of Provigil on 12 healthy male volunteers aged 30 to 44. Patients were randomized to either three days of Provigil 400 mg/day or placebo. Provigil made subjects feel more energized, alert, and quick-witted than did placebo, but it also produced more anxiety and tension (Taneja I et al., J Clin Psychopharm Feb 2007;27(1):76-78). In a separate report on the same subjects, Provigil was associated with a nine-beat increase in heart rate, a seven-point increase in systolic blood pressure, and a five-point increase in dias- tolic blood pressure (Taneja I et al., Hypertension 2005;45:612).

TCPR’s Take: Provigil energizes but causes autonomic activation when given to non-fatigued volunteers. This could be hazardous for people with cardiac disease. Let patients know that there are hazards associated with sharing their Provigil with family or friends who seek a quick boost. Caffeine is probably safer.