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 a histamine 3 (H3) receptor antagonist/inverse agonist (an antihistamine drug specific to that kind of receptors).[3] It represents the first commercially available medication in its class, so that the US 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. Retrieved 25 March 2024.
^ abc"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 EPAR was invoked but never defined (see the help page).
^Cite error: The named reference Ozawade EPAR was 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 snapshot was invoked but never defined (see the help page).
Pitolisant, sold under the brand name Wakix among others, is a medication used for the treatment of excessive daytime sleepiness in adults with narcolepsy...
the brain. Pitolisant is an histamine 3 (H3)-receptor inverse agonist. As histamine 3 (H3) receptors mainly act as autoreceptors, pitolisant decreases...
which acts as a norepinephrine–dopamine reuptake inhibitor (NDRI), and pitolisant, which acts as a histamine 3 (H3) receptor antagonist/inverse agonist...
clobenpropit, ABT-239, ciproxifan, conessine, A-349,821, betahistine, and pitolisant. The histamine H3 receptor (H3R) was discovered in 1983 and was one of...
histamine release in hypothalamus. An inverse agonist of the histamine H3 is Pitolisant. Results after testing on animals have indicated increased wakefulness...
conditions such as long QT syndrome, by certain medications such as sotalol or pitolisant, by disturbances in the concentrations of certain salts within the blood...
2011). "The histamine H3 receptor: from discovery to clinical trials with pitolisant". British Journal of Pharmacology. 163 (4): 713–21. doi:10.1111/j.1476-5381...
(nCPAP) Therapy (0249-015). http://ClinicalTrials.gov/show/NCT00620659 Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic...
other wakefulness-promoting agents including modafinil, armodafinil, and pitolisant. Solriamfetol is available in the form of 75 and 150 mg oral tablets....
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