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.

New clinically meaningful electrocardiogram abnormalities were rare with the modafinil and placebo group.

Modafinil did not affect sleep architecture in any patient population according to polysomnography.

Clinically significant abnormalities in mean laboratory parameters were observed in less than one percent of patients in modafinil-treated patients at the final visit.

"Modafinil is well tolerated. Furthermore, it appears from these prospective research studies that daily modafinil administration confers a low risk of adverse events or severe adverse events. These results make for a positive risk-benefit ratio for using modafinil to treat excessive sleepiness in patients with shift work sleep disorder, OSA and narcolepsy," said Dr. Roth.

The American Academy of Sleep Medicine (AASM) recommends that people who suspect that they might have a sleep disorder see a primary care physician or a sleep medicine specialist for proper diagnosis and to discuss treatment options before treatment with medications is undertaken.

While modern hypnotics are considered safe, individuals should be aware that, like all medications, side effects may occur in patients.

Sleep medications are effective and safe treatments when used properly and judiciously by a patient who is under the supervision of a sleep medicine or primary care physician.

The article is entitled, "Evaluation of the Safety of Modafinil for Treatment of Excessive Sleepiness."

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