Pharmacological treatment of sleep disorder phenotypes in Parkinson's disease: a systematic review and meta-analysis of randomised controlled trials
Abstract
Background: Sleep disturbances are amongst the most prevalent and disabling non-motor symptoms in Parkinson's disease (PD), encompassing excessive daytime sleepiness (EDS), poor sleep quality, insomnia, and REM sleep behaviour disorder (RBD). The pharmacological evidence base remains fragmented across phenotypes, drug classes, and outcome instruments.
Objectives: To evaluate the efficacy and safety of pharmacological interventions for sleep disorders in PD, stratified by sleep phenotype, through a systematic review and meta-analysis of randomised controlled trials (RCTs).
Methods: Six databases were searched without restrictions. Eligible studies were RCTs in adults with PD and any sleep disturbance. Pooling was performed using random-effects models. Risk of bias was assessed with the Cochrane RoB 2 tool. The protocol was registered in PROSPERO (CRD420261412614).
Results: Twenty-nine RCTs (1913 participants; 2002 to 2025) were included. Only 17.2% of trials were at low overall risk of bias. For EDS (k = 6), the pooled ESS estimate was directionally favourable but non-significant (MD 1.75; 95% CI -0.26 to 3.75; I2 = 91%), driven predominantly by a single influential crossover trial. For overall sleep quality (k = 6), pharmacological treatment produced a statistically significant improvement in PSQI scores (MD 2.66; 95% CI 1.63 to 3.69; I2 = 71%). For insomnia symptoms (k = 3) and RBD (k = 2), pooled estimates were non-significant with high heterogeneity (I2 = 96% and 99%,…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,913 participants or records.
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