Important Documents

Individuals who would like to read more about the biological effects of pitolisant can and should make use of the U.S. National Library of Medicine (https://www.nlm.nih.gov/). You will find that a search for “pitolisant” or “histamine h3 receptor” or “histaminergic neurons” will yield many fascinating scientific papers. This is an area of active research and it is exciting to watch the story unfold.

If, however, you would like to review just a handful of documents that will tell you more about Wakix (pitolisant), we suggest that you begin with the list below. These documents are also suitable for printing and handing to your physician.

  1. Summary of Product Characteristics – This description of Wakix is much like a United States package insert. It describes the medicine, the indication, and the dosing. It also describes special warnings and precautions for use. http://ec.europa.eu/health/documents/community-register/2016/20160331133706/anx_133706_en.pdf

  2. EPAR Summary for the Public - This document summarizes the European public assessment report (EPAR) for Wakix. It explains why Wakix was recommended for use in the European Union. While the document does not go into a great deal of scientific detail, it does explain that Wakix works differently from other currently available treatments for narcolepsy. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002616/WC500204748.pdf

  3. Summary of the risk management plan (RMP) for Wakix (pitolisant) – This document summarizes the treatment benefits of Wakix as well as unknowns related to treatment benefits. It also lays out safety concerns and lays out Bioprojet’s plans to better understand the safety of Wakix. The purpose of this document is to make sure that Wakix is used as safely as possible. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Risk-management-plan_summary/human/002616/WC500196690.pdf

  4. Current Clinical Trials – This lists the pitolisant trials that are underway or completed. On this page you can also find trials that are actively recruiting and the inclusion criteria for those trials. You will see that pitolisant has been investigated for not only narcolepsy, but also obstructive sleep apnea, Parkinson’s disease, and alcohol use disorder (not yet recruiting). https://clinicaltrials.gov/ct2/results?term=pitolisant&Search=Search

  5. Pitolisant versus Placebo or Modafinil in Patients with Narcolepsy: A Double-blind, Randomised Trial – We are often asked how pitolisant compares to modafinil (Provigil). This paper answers that question. Unfortunately, it is not open-access. The link points to the abstract, but you must pay to access the full article. http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(13)70225-4/abstract