Safinamide improves sleep and daytime sleepiness in Parkinson’s disease: results from the SAFINONMOTOR study

Abstract

Background and objective Some studies observed a benefit of PD patients after treatment with safinamide in some non-motor symptoms. Our aim was to analyze the effectiveness of safinamide on sleep and daytime sleepiness in Parkinson’s disease (PD) patients. Material and methods SAFINONMOTOR is a prospective open-label single-arm study conducted in 5 centers from Spain. 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 (baseline) and V4 (6 months ± 1 month) were compared. Results Fifty 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 at V1 to 8.36 ± 4.41 at 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) and sitting inactive in a public space ( p = 0.027). A total of 21 adverse events in 11 patients (22%) were reported, 5 of which were severe (not related to safinamide). Conclusion Safinamide was well-tolerated and improved sleep and daytime sleepiness in PD patients at 6 months. Supplementary Information The online version contains supplementary material available at 10.1007/s10072-021-05607-2.

Non-motor symptoms burden in motor-fluctuating patients with Parkinson’s disease may be alleviated by safinamide: the VALE-SAFI study

“…Finally, a significant effect of safinamide on subjective sleep quality, sleep latency, sleep efficiency, and then on sleep disturbances was observed between baseline and follow-up. This finding concords with previous and preliminary reports about the effects of safinamide on sleep measured either objectively through polysomnographic recording or subjectively with different scales (Liguori et al 2018a , b ; Santos García et al 2021 ).…”

“…Moreover, the items related to sleep and fatigue, mood, apathy, attention and memory, gastrointestinal and urinary symptoms, and pain were significantly reduced at the follow-up (García et al 2021b ). Following this report, other results have been published from this multi-centre study, but separately analysed, documenting an improvement of sleep, daytime sleepiness, depression, and pain (García et al 2021a ; Labandeira et al 2021 ; Santos García et al 2021 ). Considering the importance of a comprehensive and prospective analysis including an homogeneous large sample of motor-fluctuating PD patients treated by safinamide as add-on treatment to LD, the present study collectively evaluated all these NMS at baseline and after 6 months of stable treatment in a group of sixty motor-fluctuating PD patients.…”

“…Aside from motor symptoms improvement, different recent reports demonstrated a significant effect of safinamide on NMS (Bianchi et al 2019 ; Geroin et al 2020 ; De Micco et al 2021 ; Grigoriou et al 2021 ; Peña et al 2021 ). The single open-label prospective study on different NMS performed in Spain included fifty PD patients but not all were treated with safinamide as an add-on treatment to LD (García et al 2021a , b ; Labandeira et al 2021 ; Santos García et al 2021 ). The first published result showed the significant reduction of NMSS global score after 6 months of safinamide treatment in PD patients.…”

A critical appraisal of MAO-B inhibitors in the treatment of Parkinson’s disease

“…Specifically reviewing individual parameters evaluated in the PDF-39, a distinct improvement can be seen in, for example, muscle cramps (item 37), joint pains (item 38) and unpleasant hot or cold sensations (item 39), and in the case of items 37 and 39 this difference is significant. Further clinical studies on pain symptoms have been initiated, some have already been concluded and confirm the positive effect (Grigoriou et al 2021 ; Santos Garcia et al 2021a , b ).…”

“…The so-called SAFINONMOTOR study was able to demonstrate positive effects on pain, sleep and mood (Grigoriou et al 2021 ; Laban Deira et al 2021 , Santos Garcia et al 2021a , b ). The improvement seen on sleep which was confirmed by another study focused on Rapid Eye Movement (REM) sleep behaviour disorders (Plastino et al 2021 ), exploring the clinical and video-polysomnographic changes occurred during safinamide treatment in 30 PD patients.…”