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Pitolisant

(Wakix®)

Home / Wakix®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 4.45 mg, 17.8 mg)
Drug ClassHistamine-3 (H3) receptor antagonist/inverse agonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy
  • Indicated for treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Pitolisant demonstrated significant efficacy in reducing excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea (OSA), with a mean reduction in Epworth Sleepiness Scale (ESS) scores of -3.1 (95% confidence interval (CI) [-4.1; -2.1]; p < 0.001) and a 30% improvement in fatigue (risk ratio (RR) = 1.3, [1.11; 1.53], p = 0.001).
  • In patients with narcolepsy, pitolisant effectively reduced EDS and cataplexy, showing significant improvements across various studies and subgroups, and it was well tolerated compared to modafinil, which had a higher incidence of adverse effects.
  • While solriamfetol was superior to pitolisant in reducing ESS scores (mean difference -2.88, 95% CI -4.89 to -0.88) and improving Maintenance of Wakefulness Test (MWT) scores (standardized mean difference 0.45, 95% CI 0.02-0.88), pitolisant was recognized for its balanced efficacy-safety profile, making it a strong option for treating narcolepsy in adults.
  • Pitolisant was generally well tolerated in patients with OSA and narcolepsy, with common adverse reactions including headache, insomnia, nausea, and anxiety; it exhibited fewer and shorter-duration adverse effects compared to modafinil.
  • Compared to modafinil, pitolisant showed a more balanced efficacy-safety profile, with fewer and less severe adverse effects, while solriamfetol had superior efficacy in EDS improvement, though pitolisant maintained a favorable safety profile overall.
  • Pitolisant effectively reduced EDS and cataplexy in patients with narcolepsy, particularly those with a high burden of symptoms, and showed significant improvements in EDS and fatigue in patients with OSA; treatment outcomes were consistent across various subgroups, supporting its individualized use in narcolepsy and recommendations for use in idiopathic hypersomnia and other subtypes.