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Modafinil is Effective in Treating Excessive Sleepiness Associated Disorders
October 16, 2007 at 5:15 PM
Drug News
The study, authored by Thomas Roth, PhD, of the Henry Ford Sleep Center in Detroit, Mich., focused on 1,529 outpatients who received modafinil 200, 300 or 400 mg, or a placebo once per day for up to 12 weeks. A total of 934 patients received modafinil, and 567 received a placebo. The subjects were assessed for adverse events and effects of modafinil on blood pressure/heart rate, electrocardiogram intervals, polysomnography, and clinical laboratory parameters.
According to the results, modafinil was well tolerated versus a placebo, with headache, nausea and infection the most common adverse side effect. The overall incidence of side effects was similar among the three modafinil dosage groups. Adverse events occurring more frequently in the modafinil group than in controls included headache, nausea, dry mouth, anorexia, nervousness, insomnia, anxiety, hypertension and pharyngitis. In patients taking modafinil, 19 serious adverse events occurred, while in the placebo group, there were 10 serious adverse events.
In modafinil-treated patients clinically significant increases in diastolic or systolic blood pressure were infrequent. In the narcolepsy studies one patient in the modafinil group and one in the placebo group had a clinically significant increase in heart rate.
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