Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects
Identifieur interne : 000216 ( Ncbi/Curation ); précédent : 000215; suivant : 000217Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects
Auteurs : Joëlle Micallef [France] ; Marc Rey [France] ; Alexandre Eusebio [France] ; Christine Audebert [France] ; Frank Rouby [France] ; Elisabeth Jouve [France] ; Sophie Tardieu [France] ; Oliver Blin [France]Source :
- British Journal of Clinical Pharmacology [ 0306-5251 ] ; 2009.
Abstract
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.
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.
Pramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [−6.1 min (−9.8, −2.4),
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.
Url:
DOI: 10.1111/j.1365-2125.2008.03310.x
PubMed: 19220275
PubMed Central: 2675044
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<front><div type="abstract" xml:lang="en"><sec><title>AIMS</title>
<p>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.</p>
</sec>
<sec sec-type="methods"><title>METHODS</title>
<p>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.</p>
</sec>
<sec><title>RESULTS</title>
<p>Pramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [−6.1 min (−9.8, −2.4), <italic>P</italic>
= 0.002] and 5 h 30 min [−5.6 min (−7.7, −3.5), <italic>P</italic>
= 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), <italic>P</italic>
< 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.</p>
</sec>
<sec><title>CONCLUSIONS</title>
<p>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.</p>
</sec>
</div>
</front>
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