Sleep disorders are a multifactorial and complex dimension of Parkinson's disease, encompassing a spectrum ranging from insomnia and sleep fragmentation to excessive daytime sleepiness and REM sleep behavior disorder. A critical aspect of strategic management is the differentiation of underlying causes, which may include nocturnal motor symptoms, comorbidities, or adverse effects of other medications. The panel evaluated the role of safinamide in this context, primarily from a safety and indirect benefit perspective.
According to experts in the field, classical literature has historically accorded minimal attention to the issue of sleep symptoms, often relegating them to a secondary category in the context of motor fluctuations or considering them as a potential adverse effect of medication. The primary strategy employed by the panel was to "optimize the management of motor symptoms," with the hypothesis that this would result in a secondary improvement in sleep quality. In cases where pharmacological treatment was deemed necessary, the following medications were commonly prescribed:
Trazodone
Gabapentin
Pregabalin
Clonazepam
Quetiapine
Clozapine
The panel reached a consensus that safinamide is not primarily indicated for the treatment of sleep disorders. Its utilization is indicated for patients exhibiting motor fluctuations, with any enhancement in sleep being regarded as an "indirect effect" or "side effect" emanating from augmented motor control during nocturnal hours.
The primary benefit and overarching consensus of the panel center on the exceptional, impartial, and beneficial safety profile of safinamide with respect to sleep. In contrast to other drugs, such as dopamine agonists, it does not cause or exacerbate problems such as excessive daytime sleepiness or REM sleep behavior disorder. This feature is a significant clinical differentiator.
Despite the findings of preliminary studies indicating enhancements in sleep scales, a consensus among experts in the field is that further substantiation is necessary to formally designate it as an indication. In clinical practice, it is not common for panelists to modify or discontinue other sleep medications when initiating safinamide.
As in the case of pain, the panel's general preference is to target a dose of 100 mg. The rationale underlying this approach is to ensure the dual action of the pharmaceutical agent, despite the absence of direct comparative experience regarding both doses and the specific symptom of sleep.