Objective: To investigate the efficacy of levodopa/carbidopa/entacapone (Stalevo®) at bedtime on sleep disturbance in patients with Parkinson’s disease (PD) who have motor fluctuation.

Background: Sleep disturbances, such as sleep onset insomnia, sleep fragmentation, rapid eye movement sleep behavior disorder (RBD), and excessive daytime sleepiness is the major disabling non-motor symptoms of PD. Clinical motor and nonmotor symptoms associated with sleep disturbance are still unclear and no choice of treatment has been demonstrated.

Methods: We studied 54 PD patients with motor fluctuation and sleep disturbance that was defined as Parkinson’s Disease Sleep Scale (PDSS) ≤120 or Epworth Sleepiness Scale (ESS) ≥8. In this open-label study, PD patients were prescribed with additional bedtime Stalevo®. We assessed motor and nonmotor scales, including PDSS, ESS, RBD Sleep Questionnaire (RBDSQ), United Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Quality of Life Questionaire-39 (PDQ-39), and Nonmotor Symptom assessment scale (NMSS). Sleep improvement by bedtime Stalevo® was defined as more than 15% improvement in PDSS scores in 3 months.

Results: The assessment at 3 months after the start of bedtime Stalevo® was completed in 34 PD patients (63%). Sleep improvement by bedtime Stalevo® was observed in 18 (53% of 34) patients but there was no improvement in 16 (47% of 34). At baseline, PDSS score was significantly lower in sleep improvement group compared with no improvement group (P = 0.025) [table1]. At 3 months, NMSS score as well as the PDSS score were much improved significantly in sleep improvement group compared with no improvement group [table2]. At 3 months, ESS, RBDSQ, total UPDRS, and NMSS scores as well as the PDSS score were significantly improved in sleep improvement group compared to the scores at baseline [table3], suggesting the overall improvement of sleep quality, nonmotor and motor symptoms in this group.

Conclusions: Our results suggest that bedtime Stalevo® may have beneficial effect on sleep disturbance of PD patients with motor fluctuation. Further studies are needed to identify the determining factors of efficacy of bedtime Stalevo® in those PD patients.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-bedtime-levodopa-carpidopa-entacapone-stalevo-on-sleep-disturbance-in-patients-with-parkinsons-disease-with-motor-fluctuation/