Pergolid Mesylate (PERMAX): Warning About Falling Asleep and Auto Accidents

On December 22nd, FDA and Lilly modified the label for pergolid mesylate (PERMAX), a drug used in the treatment of Parkinson’s disease, and informed healthcare professionals of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with pergolid mesylate. Although the patient information in the revised label does not mention auto accidents, the professional information, printed below, does.

Falling Asleep During Activities of Daily Living — Patients treated with pergolid mesylate have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on pergolid mesylate, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as 1 year after the initiation of treatment. Somnolence is a common occurrence in patients receiving pergolid mesylate. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with pergolid mesylate, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with pergolid mesylate such as concomitant sedating medications or the presence of sleep disorders. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require participation (e.g., conversations, eating, etc.), pergolid mesylate should ordinarily be discontinued. If a decision is made to continue pergolid mesylate, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction may reduce the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

What You Can Do

As mentioned above, if you develop significant daytime sleepiness or episodes of falling asleep during activities that require participation (e.g., conversations, eating, etc.), you should discontinue pergolid mesylate. If a decision is made to continue pergolid mesylate, you should be advised to not drive and to avoid other potentially dangerous activities.