Objective: Our aim was to analyze the effectiveness of safinamide on sleep in Parkinson´s disease (PD) patients from the SAFINONMOTOR (an open-label study of the effectiveness of SAFInamide on NON-MOTOR symptoms in Parkinson´s disease patients) study.
Background: Some studies observed a benefit of PD patients after treatment with safinamide in some non-motor symptoms such as pain, mood, sleep or cognition.
Method: SAFINONMOTOR is a prospective open-label single-arm study conducted in 5 centers from Spain. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the Non-Motor Symptoms Scale total score. In this analysis, a secondary objective of the study, the score in the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) at V1 and V4 were compared. Wilconxon´s rank sum test was performed for testing the changes from V1 to V4.
Results: 50 patients were included between May/2019 and February/2020 (age 68.5 ± 9.12 years; 58% women; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The PSQI total score was reduced by 19.8% (from 10.43 ± 4.02 in V1 to 8.36 ± 4.41 in V4; p=0.001). By domains, improvement was observed in subjective sleep quality (PSQI-C1; -23.9%; p=0.009), sleep latency (PSQI-C2; -25%; p=0.025), sleep duration (PSQI-C3; -40%; p=0.001), and habitual sleep efficiency (PSQI-C4; -25.9%; p=0.023). A significant reduction (-24.7%) in the ESS total score from V1 to V4 was observed as well (from 9.20 ± 5.64 to 6.93 ± 5.11; p=0.012). Specifically, the improvement in daytime sleepiness was observed in sitting and reading (p=0.024), watching television (p=.011) and sitting inactive in a public space (p=0.027). A moderate correlation between the change in quality of life (QoL) (PDQ-39SI [39-item Parkinson’s Disease Quality of Life Questionnaire Summary Index] from V1 to V4) and daytime sleepiness (ESS from V1 to V4) was observed (r=0.352; p=0.024) but not between QoL and sleep (PSQI from V1 to V4) (r=0.260; p=0.115). A total of 21 adverse events in 11 patients (22%) were reported, 5 of which were severe (not related to safinamide).
Conclusion: Safinamide is well tolerated and improves sleep and daytime sleepiness in PD patients at 6 months.
To cite this abstract in AMA style:
I. Cabo López, C. Labandeira Guerra, R. Yáñez Baña, MI. Cimas Hernando, JM. Paz González, MG. Alonso Losada, MJ. González Palmás, C. Martínez Miró, D. Santos García. Safinamide Improves Sleep and Daytime Sleepiness in Parkinson´s Disease. Results from the SAFINONMOTOR Study [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/safinamide-improves-sleep-and-daytime-sleepiness-in-parkinsons-disease-results-from-the-safinonmotor-study/. Accessed May 21, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-improves-sleep-and-daytime-sleepiness-in-parkinsons-disease-results-from-the-safinonmotor-study/