Exploring the Top 50 Drugs Associated with Restless Legs Syndrome Based on the FDA Data from 2004 to 2024

Drugs-associated restless legs syndrome(RLS) can significantly impact patients' quality of life. This study aims to identify the 50 most common drugs-associated with RLS in the FDA Adverse Event Reporting System (FAERS) database and track its epidemiological characteristics.

We extracted reports of adverse drug events related to restless legs syndrome from the FAERS database, covering the period from Q1 2004 to Q3 2024. We compiled a list of the 50 most frequently reported drugs based on RLS reports. Four risk signal detection methods were employed to assess whether valid signals were triggered by these drugs: Reporting Odds Ratio, Proportional Reporting Ratio, Multi-item Gamma Poisson Shrinker, and Information Component from the Bayesian Confidence Propagation Neural Network. Logistic regression evaluated risk factors, and the Weibull Shape Parameter (WSP) test analyzed time-to-onset (TTO).

A total of 16,410 reports were linked to RLS, with sodium oxybate being the most common (648 cases, 3.9%). Nervous system medications comprised 31.3% of cases. Of the 50 drugs, 27 showed valid risk signals; only 6 were consistent with FDA labels. Risk factors included age under 44, weight over 64 kg, female gender, and 24 specific drugs. TTO analysis revealed that most drugs exhibited early onset patterns.

Our study highlights drugs potentially linked to drug-associated RLS emphasizing the need to consider these risks in clinical practice.