Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 4.45 mg, 17.8 mg) |
| Drug Class | Histamine-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.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Wakix (pitolisant) Prescribing Information. | 2024 | Harmony Biosciences, LLC, Plymouth Meeting, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacological Interventions for Excessive Daytime Sleepiness in Adults with Narcolepsy: A Systematic Review and Network Meta-Analysis | 2022 | Journal of Clinical Medicine |
| Solriamfetol for the Use of Narcolepsy: A Systematic Review | 2022 | Cureus |
| Efficacy of Pitolisant 20 mg in Reducing Excessive Daytime Sleepiness and Fatigue in Patients with Obstructive Sleep Apnoea Syndrome: An Individual Patient Data Meta-analysis | 2022 | Clinical Drug Investigation |
| Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment | 2021 | Journal of Clinical Sleep Medicine |
| Efficacy of Pitolisant on the Treatment of Narcolepsy: A Systematic Review | 2021 | Cureus |
| Evaluating pitolisant as a narcolepsy treatment option | 2021 | Expert Opinion on Pharmacotherapy |
| Pitolisant for treating patients with narcolepsy | 2020 | Expert Review of Clinical Pharmacology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline | 2021 | Journal of Clinical Sleep Medicine |
| European guideline and expert statements on the management of narcolepsy in adults and children | 2021 | European Journal of Neurology |