Apo-Pramipexole Warnings

Sudden Onset of Sleep: Patients receiving treatment with pramipexole dihydrochloride monohydrate and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including operating a motor vehicle, which sometimes resulted in accidents. Although some of the patients reported somnolence while on pramipexole dihydrochloride monohydrate, others perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Physicians should alert patients of the reported cases of sudden onset of sleep, bearing in mind that these events are NOT limited to initiation of therapy. Patients should also be advised that sudden onset of sleep has occurred without warning signs. If drowsiness or sudden onset of sleep should occur, patients should immediately contact their physician.
Until further information is available on the management of this unpredictable and serious adverse event, patients should be warned not to drive or engage in other activities where impaired alertness could put themselves and others at risk of serious injury or death (e.g., operating machines). Substituting other dopamine agonists may not alleviate these symptoms, as episodes of falling asleep while engaged in activities of daily living have also been reported in patients taking these products.
While dose reduction clearly reduces 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.
Presently, the precise cause of this event is unknown. It is known that many Parkinson's disease patients experience alterations in sleep architecture, which results in excessive daytime sleepiness or spontaneous dozing, and that dopaminergic agents can also induce sleepiness.