Rotigotine may improve sleep architecture in Parkinson's Disease: a double-blind, randomized, placebo-controlled polysomnographic study.

Publication date: Available online 17 February 2016
Source:Sleep Medicine
Author(s): Mariangela Pierantozzi, Fabio Placidi, Claudio Liguori, Maria Albanese, Paola Imbriani, Maria Grazia Marciani, Nicola Biagio Mercuri, Paolo Stanzione, Alessandro Stefani
Background/ObjectivesGrowing evidence demonstrates that in Parkinson's Disease (PD) sleep disturbances are frequent and difficult to treat. Since the efficacy of rotigotine on sleep is corroborated by studies lacking polysomnography (PSG), this study would explore the possible rotigotine-mediated impact on PSG parameters in PD patients.MethodsThis is a randomized, double-blind, placebo-controlled, parallel-group study to determine the efficacy of rotigotine vs placebo on PSG parameters in moderately advanced PD patients.We evaluate 42 PD patients (Hoehn & Yahr stage 2–3) with sleep impairment, randomly assigned to active branch (N = 21) or placebo (N = 21). An unconventional protocol was utilized, since either patch was maintained from 18:00 h to awakening, minimizing the possible diurnal impact on motor and non-motor symptoms. All participants underwent sleep PSG recordings, subjective sleep questionnaires (Parkinson Disease Sleep Scale (PDSS), Pittsburgh Sleep Quality Index (PSQI)), and the assessment of early-morning motor disability.ResultsRotigotine significantly increased sleep efficiency and reduced both wakefulness after sleep onset and sleep latency compared to placebo. Moreover, the mean change in REM sleep quantity was significantly higher in the rotigotine than in the placebo group. The objective improvement in PSG corresponded to the amelioration of PDSS and PSQI scores together with an improvement of patient morning motor symptoms.ConclusionsThis study demonstrated the significant effect of rotigotine on sleep quality and continuity in PD patients, by promoting sleep stability and increasing REM. The effectiveness of rotigotine on sleep may be ascribed to its pharmacokinetic/pharmacodynamic profile directly on both D1 and D2 receptors.



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