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Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects.
- Source :
-
British journal of clinical pharmacology [Br J Clin Pharmacol] 2009 Mar; Vol. 67 (3), pp. 333-40. Date of Electronic Publication: 2008 Sep 19. - Publication Year :
- 2009
-
Abstract
- Aims: To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.<br />Methods: Placebo, bromocriptine (2.5 mg), L-dopa (100 mg) and pramipexole (0.5 mg) were administered in a single oral dose on four separate days, with at least a 2-week wash-out period in a randomized cross-over design. Induced somnolence was assessed using Multiple Sleep Latency Test (MSLT) and subjective scaling of vigilance. Twelve male subjects (26.3 +/- 5.5 years old) without anxiety, mood, sleep or sedation disorders were enrolled.<br />Results: Pramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [-6.1 min (-9.8, -2.4), P = 0.002] and 5 h 30 min [-5.6 min (-7.7, -3.5), P = 0.003] after administration. In addition, the total duration of sleep during the tests was higher with pramipexole than with placebo [+6.0 min (2.3, 9.7), P < 0.001]. These differences were not observed with L-dopa and bromocriptine in comparison with placebo. The induced sleepiness was not associated with an increase in subjective somnolence scaling, indicating that this adverse event may occur without prior warning.<br />Conclusions: These results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.
- Subjects :
- Adolescent
Adult
Cross-Over Studies
Double-Blind Method
Humans
Male
Middle Aged
Polysomnography
Pramipexole
Treatment Outcome
Young Adult
Antiparkinson Agents adverse effects
Benzothiazoles adverse effects
Bromocriptine adverse effects
Levodopa adverse effects
Parkinson Disease drug therapy
Sleep Wake Disorders chemically induced
Subjects
Details
- Language :
- English
- ISSN :
- 1365-2125
- Volume :
- 67
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- British journal of clinical pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 19220275
- Full Text :
- https://doi.org/10.1111/j.1365-2125.2008.03310.x