Eficacia y seguridad del Pitolisant en el tratamiento de la narcolepsia: revisión sistemática

Abstract

Title: Efficacy and Safety of Pitolisant in the Treatment of Narcolepsy: A Systematic Review. Objective: To determine the efficacy and safety of pitolisant in the treatment of narcolepsy. Methods: A systematic review was conducted in accordance with PRISMA 2020 guidelines, using the databases Scopus, PubMed, ScienceDirect, SciELO, and Cochrane Library. Scientific studies published between 2020 and 2025 were included randomized clinical trials, meta-analyses, and full-text articles in Spanish or English on patients diagnosed with narcolepsy. The search incorporated Health Sciences Descriptors (DeCS) and Medical Subject Headings (MeSH), combined with Boolean operators AND and OR. Results: Fifteen studies were included after applying tools such as the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Grading of Recommendations Assessment, Development and Evaluation (GRADE), and OXFORD. A total of 100 studies were excluded because they did not meet the methodological criteria, and 181 were excluded based on the selection criteria. Discussion: Pitolisant is presented as an effective and safe therapeutic option for narcolepsy, reducing excessive daytime sleepiness (EDS) and cataplexy, improving quality of life. Its safety profile is favorable, with mild and transient adverse effects. Limitations: The review identified publication and citation biases, difficulties with duplicate studies, exclusion of languages other than English and Spanish, and a lack of data on long-term effects. Conclusions: Pitolisant is an effective and safe therapeutic option for narcolepsy, demonstrating low abuse potential and a favorable adverse effect profile. Keywords: Efficacy, narcolepsy, pitolisant, safety