Dopaminergic treatment in idiopathic restless legs syndrome: effects on subjective sleepiness.
OBJECTIVE
To assess frequency and characteristics of excessive daytime sleepiness (EDS) in restless legs syndrome (RLS) and the evolution of EDS under different RLS therapies.


METHODS
We analyzed data from the "Swiss RLS" study, which was conducted to compare treatment efficacy and safety of the dopamine agonist pramipexole (PPX) versus L-dopa/benserazide (L/B) in de novo patients with idiopathic RLS and performed as a randomized, double-dummy, comparative crossover trial. Primary outcome measure of the present study was the change in subjective sleepiness (as measured by Epworth sleepiness scale [ESS] score). There were 37 patients (21 women) included. Mean age was 56.6 years (range, 25-85 years), and mean body mass index was 24.6 (SD, ±3.5).


RESULTS
At baseline, EDS (as determined by an ESS score of >10) was found in 32% of the patients. Sleepy RLS patients were younger (P < 0.001) than non-sleepy patients. Pramipexole and L/B both were effective in the treatment of RLS symptoms (IRLS score, P < 0.001 and P = 0.002). Overall, ESS was reduced (main effect for "time", P = 0.02) independent from the dopaminergic substance. In 5 of 37 patients, ESS score deteriorated to greater than 10 under treatment (PPX = 3 patients, L/B = 2 patients). No sleep attack occurred.


CONCLUSIONS
Excessive daytime sleepiness is frequent in RLS patients. Dopaminergic treatment usually promotes wakefulness, but infrequently leads to daytime sleepiness.
Department of Neurology, University Hospital Zurich, Zurich, Switzerland. ulf.kallweit@usz.ch
Ulf
U
Kallweit
Ramin
R
Khatami
Fabio
F
Pizza
Johannes
J
Mathis
Claudio L
CL
Bassetti
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety; D001545:Benserazide / Q000009:adverse effects / Q000627:therapeutic use; D052160:Benzothiazoles / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D003863:Depression; D006970:Disorders of Excessive Somnolence / Q000209:etiology* / Q000503:physiopathology; D018491:Dopamine Agonists / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007980:Levodopa / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D000077487:Pramipexole; D012148:Restless Legs Syndrome / Q000150:complications* / Q000188:drug therapy*; D012720:Severity of Illness Index; D012894:Sleep Stages / Q000187:drug effects; D013997:Time Factors; D014851:Wakefulness / Q000187:drug effects
D052160:Benzothiazoles; D018491:Dopamine Agonists; D004338:Drug Combinations; C005177:benserazide, levodopa drug combination; D007980:Levodopa; D001545:Benserazide; D000077487:Pramipexole