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12/22/2003

Sudden Somnolence Associated With Permax

Kate Traynor

Eli Lilly and Company recently issued a "Dear Health Care Professional" letter warning that some patients who take Permax, or pergolide mesylate, may fall suddenly asleep while driving a car or performing other daily activities.

Of particular concern to Lilly and the Food and Drug Administration's MedWatch adverse-event reporting system are reports of patients falling asleep without any warning. According to the letter, some patients who took the product have been involved in motor vehicle accidents after falling asleep while driving.

Lilly has revised the product's labeling to more explicitly alert health care providers about the drug-related somnolence, a common adverse event associated with the product. In some cases, sudden somnolence occurred up to a year after the patient began using the drug.

The revised labeling advises patients who suffer "increased somnolence" while taking the drug, or who begin to fall asleep during routine activities such as watching television, to consult a physician about the advisability of driving or performing other "potentially dangerous activities."