Pitolisant as Adjunct Therapy for Refractory Restless Legs Syndrome: Insights from a Pilot Study

Highlight

• Pitolisant, a histamine-3 inverse agonist stimulatory agent, was tested as adjunctive therapy in refractory restless legs syndrome (RLS).
• In a small open-label trial, pitolisant significantly improved International RLS Rating Scale scores and daytime sleepiness scales over 8 weeks.
• Improvement was more notable in daytime consequences such as sleepiness rather than core RLS symptoms.
• Adverse events were generally mild, with insomnia being most frequent; pitolisant was overall well tolerated.

Study Background and Disease Burden