Modafinil, a non-amphetamine central nervous system stimulant, is a wakefulness-promoting agent indicated for use in shift work sleep disorder, narcolepsy, and obstructive sleep apnea. The trend in modafinil overexposure over a ten-year period and the population likely to experience a resulting clinical effect is evaluated. Methods: Using data from the American Association of Poison Control Center (AAPCC) National Poison Data System (NPDS), a retrospective review of all reported modafinil

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... posures over a ten-year period (2001-2010) was conducted. In order to determine whether age, reason and acuity had a role in predicting medical outcome, odds ratios (OR) were calculated using binomial logistic regression analysis. Results: There were 1,100 modafinil overexposures reported with known outcomes, of which 600 cases (54%) were women and 367 (33%) were ≤ 5 years old. Seventy-seven percent of the exposures were acute ingestions and the majority was unintentional. The number of reported modafinil exposures increased with time until 2007. Adults were more likely to have an adverse effect than children ≤ 5 years of age. Patients with an intentional overexposure were more likely to have an effect than those with an unintentional overexposure (OR = 5.2; 95% CI 3.9-7.1; P < 0.001). Conclusion: The frequency of reported modafinil exposures increased with time until 2007. The majority of exposures resulted in no adverse clinical effect. Older patients and those with intentional exposure were more likely to experience a clinical effect.