Risk of Suicidal Ideation and Behavior Following Early-Onset Idiopathic Restless Legs Syndrome Treatment

Area of Science:

• Neuroscience
• Pharmacology
• Clinical Research

Background:

• Restless Legs Syndrome (RLS) is a neurological disorder affecting millions.
• Early-onset RLS often requires long-term management with medications like gabapentinoids and dopamine agonists (DAs).
• Understanding the comparative safety profiles of these treatments regarding suicidality is crucial for patient care.

Purpose of the Study:

• To estimate and compare incidence rates of suicidal ideation and behavior.
• To assess suicidal behavior risk between gabapentinoid and DA initiators in newly diagnosed early-onset idiopathic RLS.
• To identify potential safety signals associated with these RLS pharmacotherapies.

Main Methods:

• Retrospective cohort study utilizing MarketScan claims data (2012-2019).
• Inclusion of patients with newly diagnosed early-onset idiopathic RLS initiating monotherapy gabapentinoids or DAs.
• Analysis of suicidality outcomes using log-binomial regression and propensity score weighting for covariate adjustment.

Main Results:

• The cohort comprised 6672 patients; 25.3% initiated gabapentinoids and 74.7% initiated DAs.
• Higher incidence rates of suicidality, self-harm, and overdose events were observed in the gabapentinoid group.
• Adjusted analyses revealed no statistically significant increased risk for suicidality with gabapentinoids compared to DAs.

Conclusions:

• While incidence rates of suicidal ideation and behavior were higher in the gabapentinoid group, no significant increase in risk was detected after adjustment.
• The findings suggest that gabapentinoids may not significantly elevate suicidality risk in RLS patients compared to DAs.
• Limitations and the rarity of outcomes warrant cautious interpretation, and a potential signal cannot be entirely excluded.