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This open-label study sought to investigate pitolisant as adjunct therapy for the management of refractory restless legs syndrome (RLS).
Pitolisant significantly improves symptom severity, daytime sleepiness, and overall functioning in patients with refractory restless legs syndrome, while being generally well-tolerated.
This open-label study sought to investigate pitolisant as adjunct therapy for the management of refractory restless legs syndrome (RLS).
In this pilot study, pitolisant was titrated up to a maximum morning dose of 35.6 mg in patients with persistent RLS symptoms despite being on at least one RLS medication. The key outcome measure was the International RLS Rating Scale (IRLSRS) at 8 weeks, while patients continued stable use of their existing RLS therapies. Secondary outcomes encompassed evaluations of fatigue, daytime sleepiness, and cognitive function. Following the initial 8 weeks, volunteers continued pitolisant for another 8 weeks with the option to adjust other RLS therapies.
A total of 21 patients were enrolled (mean age 67.6 ± 10.2 years; 12 male; 16 with a familial RLS history). Volunteers were concurrently using dopaminergic agents (15), gabapentinoids (9), and opioids (8), with 11 on combination therapy. Notably, 2 individuals discontinued—one due to worsened ADHD/irritability and the other lost to follow-up.
Two others did not reach the full 35.6 mg dose. After 8 weeks, the IRLSRS scores markedly improved from 24.5 ± 4.6 to 17.2 ± 5.5 (N = 21), with 8 out of 19 reporting marked or very marked improvement. The RLS-6 scale and Epworth Sleepiness Scale also showed improvement, while measures of fatigue, depression, and cognition remained unchanged. A total of 9 participants experienced adverse effects, with insomnia reported by 6.
Pitolisant (a histamine-3 inverse agonist) was usually well-tolerated and illustrated improvements in RLS-related measures. These findings suggest pitolisant may be more beneficial in alleviating the daytime consequences of RLS than in targeting the core symptoms.
Sleep Medicine
Pilot study of Pitolisant, a histamine-3 inverse agonist, as adjunct therapy for refractory restless legs syndrome
William G. Ondo et al.
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