Canada - Recent adverse drug reaction reports associated with pramipexole (Mirapex®) and ropinirole (Requip®) have included a higher proportion of sleep disorder cases. Sleep-related disorders constituted 26 of 57 reports and 16 out of 17 of the reports of adverse reactions associated with ropinirole and pramipexole, reported to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) as of 10 October 2000. Nineteen of those associated with ropinirole and all 16 of those associated with pramipexole, were of sudden onset of sleep, or variant. In some of these cases, the patient was driving when the event occurred. The episodes typically only last for a few seconds and are often not preceded by warning symptoms such as unusual fatigue.

Warnings have previously been issued not to drive or engage in other activities in which impaired alertness may impose increased risk and the Canadian Medical Association has published guidelines to assist physicians in evaluating a patient’s ability to drive.

Reference: Canadian Adverse Drug Reaction Newsletter, 11: 1 - 2, April 2001.