Modafinil Is Effective In Treating Excessive Sleepiness, Study Suggests

[Guest guest]

Modafinil Is Effective In Treating Excessive Sleepiness, Study

Suggests

http://www.sciencedaily.com/releases/2007/10/071015081534.htm

A study published in the October 15 issue of the Journal of Clinical Sleep

Medicine finds that modafinil is well-tolerated in the treatment of excessive

sleepiness associated with disorders of sleep and wakefulness such as shift work

sleep disorder, obstructive sleep apnea (OSA) and narcolepsy, and does not

affect cardiovascular or sleep parameters.

The study, authored by 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. "