Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 4.45 mg, 17.8 mg) |
| Drug Class | Histamine-3 receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
Summary
- Pitolisant (Wakix) is indicated for the treatment of excessive daytime sleepiness in adult patients with narcolepsy, demonstrating significant efficacy in reducing fatigue and improving excessive daytime sleepiness, especially among this patient group.
- Six systematic reviews/meta-analyses were examined to gather information about Wakix's effectiveness and safety profile compared to other drugs used for similar conditions.
- Compared to solriamfetol, armodafinil-modafinil, and sodium oxybate, pitolisant offers a balanced efficacy-safety profile, presenting fewer adverse events than modafinil, with insomnia being the only significantly associated treatment-emergent adverse event.
- The drug exhibits good tolerability across studies, but its performance is moderate when compared to solriamfetol and armodafinil-modafinil based on Epworth Sleepiness Scale (ESS) scores and Maintenance of Wakefulness Test (MWT).
- All drugs, including pitolisant, prove effective in improving excessive daytime sleepiness in patients already receiving conventional therapy. However, individual therapy selections are recommended due to varying safety profiles. Special considerations involve pitolisant's unique mechanism as a histamine H3 receptor antagonist/inverse agonist, offering an alternative approach without an increased risk of significant adverse events associated with stimulant-type medications.
- The limitations regarding evidence of long-term outcomes highlight the need for further research, particularly among patients with nonadherent or mixed adherence to obstructive sleep apnea therapies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Wakix (pitolisant) Prescribing Information. | 2022 | Harmony Biosciences, LLC, Plymouth Meeting, PA |
Systematic Reviews / Meta-Analyses
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 | Journal of Sleep Research |