Safety of pramipexole in patients with restless legs syndrome.

Abstract

In 1999, falling asleep at the wheel was reported as a new and worrisome side effect in eight patients with PD treated with nonergot dopamine agonists (DA). Five of these patients reported sudden unexpected “sleep attacks” without preceding fatigue.1 Subsequently, more patients who were treated with DA (including ergot DA) for PD have been reported to have similar sleep attacks.2 Because the nonergot DA pramipexole is successfully used in the treatment of restless legs syndrome (RLS),3 we investigated its safety with particular regard to sleep attacks in patients with RLS. We surveyed all patients in our outpatient clinic who have been treated with pramipexole to control RLS symptoms by a mailed questionnaire. Patients were asked about side effects of pramipexole, occurrence and degree of daytime fatigue, occurrence of unexpected dozing off (sleep attacks), dozing off due to tiredness (sleep episodes) and its relationship to drug intake, and intake of other drugs. …