Structured management of dopamine agonist withdrawal in restless legs syndrome with augmentation: A prospective real-world cohort study.

INTRODUCTION: Augmentation is a major complication of dopamine agonist (DA) therapy for restless legs syndrome (RLS) and its management continues to be a major clinical challenge. We sought to evaluate the feasibility and efficacy of a structured protocol designed to achieve complete DA withdrawal within one month. METHODS: In this prospective observational cohort at a specialized sleep center, consecutive adults with RLS and clinically significant augmentation treated with DA therapy underwent a structured withdrawal protocol that included rapid DA tapering, iron optimization, and alpha-2-delta ligand initiation or increase, with the dopamine partial agonist, aripiprazole, considered as an adjunctive option in patients with significant worsening. RESULTS: Of 31 patients, 24 (77%) achieved complete DA withdrawal at one month. Mean International RLS score improved from 27.1 to 15.1 and Clinical Global Impressions Severity from 5.2 to 3.5 (both p < 0.001), while gabapentin-equivalent dose increased from 417 to 1288 mg/day. Longer augmentation duration was associated with failure to withdraw (11.4 vs. 3.5 years; p = 0.003). Aripiprazole use during tapering was associated with successful withdrawal. CONCLUSIONS: A structured protocol achieved complete DA withdrawal in the majority of patients within one month, with short-term clinical improvement. Early management of augmentation improves the likelihood of successful withdrawal.