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Pitolisant
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| Pronunciation | /pɪˈtɒlɪsənt/ pi-TOL-i-sənt |
| Trade names | Wakix, Ozawade |
| Other names | Tiprolisant; Ciproxidine; BF2.649 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619055 |
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| Routes of administration | By mouth |
| Drug class | Histamine H3 receptor inverse agonist |
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| Pharmacokinetic data | |
| Elimination half-life | 10–12 hours |
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| Chemical and physical data | |
| Formula | C17H26ClNO |
| Molar mass | 295.85 g·mol−1 |
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Pitolisant, sold under the brand name Wakix among others, is a medication used for the treatment of excessive daytime sleepiness in adults with narcolepsy.[3] It is an inverse agonist of the histamine 3 (H3) receptor (an antihistamine drug specific to that kind of receptors).[3] It represents the first commercially available medication in its class, so that the U.S. Food and Drug Administration (FDA) declares it a first-in-class medication.[7][8] Pitolisant enhances the activity of histaminergic neurons in the brain that function to improve a person's wakefulness.[9] It was approved by the European Medicines Agency (EMA) in March 2016 for narcolepsy with or without cataplexy, and for excessive daytime sleepiness by the FDA in August 2019.[10] The most common side effects include difficulty sleeping, nausea, and feeling worried.[11]
- ^ "Summary Basis of Decision (SBD) for Wakix". Health Canada. 23 October 2014. Archived from the original on 22 December 2022. Retrieved 29 May 2022.
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
- ^ a b c "Wakix- pitolisant hydrochloride tablet, film coated". DailyMed. 6 November 2019. Archived from the original on 11 August 2020. Retrieved 18 August 2020.
- ^ Cite error: The named reference
Wakix EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Ozawade EPARwas invoked but never defined (see the help page). - ^ "Ozawade Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
- ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration (FDA). 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.
- ^ "FDA Approves Pitolisant for Daytime Sleepiness in Patients with Narcolepsy". Pharmacy Times. 16 August 2019. Archived from the original on 12 August 2020. Retrieved 18 August 2020.
- ^ Syed YY (September 2016). "Pitolisant: First Global Approval". Drugs. 76 (13): 1313–1318. doi:10.1007/s40265-016-0620-1. PMID 27438291. S2CID 42684839.
- ^ Giliberto S, Shishodia R, Nastruz M, Brar C, Bulathsinhala S, Terry J, Pemminati S, Shenoy SK (March 2024). "A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022)". Cureus. 16 (3): e56561. doi:10.7759/cureus.56561. PMC 11028406. PMID 38646400.
- ^ Cite error: The named reference
FDA snapshotwas invoked but never defined (see the help page).
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