{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:55:11Z","timestamp":1777420511706,"version":"3.51.4"},"reference-count":34,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To assess the efficacy and safety of pitolisant, a selective histamine H\u2083 receptor antagonist\/inverse agonist, for excessive daytime sleepiness (EDS) in narcolepsy or obstructive sleep apnea (OSA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>PubMed, Cochrane, Embase, Scopus, and Web of Science were searched through August 2025 for randomized placebo-controlled trials (RCTs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction:<\/jats:title>\n                    <jats:p>Eligible RCTs reported Epworth Sleepiness Scale (ESS) or Pediatric Daytime Sleepiness Scale (PDSS), mean sleep latency, EQ-5D, or global impression outcomes. Two reviewers independently screened studies, extracted data, and assessed bias using Cochrane RoB 2.0. Publication bias was evaluated using funnel plots and Egger\u2019s test; certainty of evidence was rated with GRADE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>\n                      Six RCTs (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 1149) met the inclusion criteria. Compared with placebo, pitolisant significantly reduced Sleepiness Scale scores (SSS) (mean difference [MD] = \u22122.97; 95% confidence interval [CI] \u22123.62 to \u22122.33), increased mean sleep latency (MD = 3.06; 95% CI 2.12-3.99), and improved EQ-5D scores (MD = 2.68;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.009). Patient global opinion (risk ratio [RR] = 1.40) and clinical global impression of change (CGI-C) (RR = 1.41) also favored pitolisant. Rates of treatment-emergent adverse events, serious adverse events, and withdrawals were comparable with placebo, and common adverse effects, such as headache, insomnia, nausea, and anxiety, were infrequent and not significantly increased.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice:<\/jats:title>\n                    <jats:p>Pitolisant provides an effective, nonstimulant option for EDS in narcolepsy and OSA, including residual symptoms despite continuous positive airway pressure (CPAP). Its distinct mechanism and tolerability profile make it a valuable alternative or adjunct to existing therapies, supporting personalized care and enhanced daily functioning.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance:<\/jats:title>\n                    <jats:p>Pitolisant significantly improves subjective and objective wakefulness and quality of life in EDS due to narcolepsy or OSA, with robust evidence for ESS benefit and a favorable safety profile.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280251390557","type":"journal-article","created":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T14:03:08Z","timestamp":1764597788000},"page":"394-408","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and Safety of Pitolisant for Excessive Daytime Sleepiness in Narcolepsy and Obstructive Sleep Apnea: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials"],"prefix":"10.1177","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-5835-9811","authenticated-orcid":false,"given":"Amna Amir","family":"Jalal","sequence":"first","affiliation":[{"name":"Jinnah Sindh Medical University, Karachi, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-4229-777X","authenticated-orcid":false,"given":"Syed Ibad","family":"Hussain","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University, Karachi, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4228-6476","authenticated-orcid":false,"given":"Muhammad Saad","family":"Khan","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University, Karachi, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erum","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University, Karachi, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harshika Khaim","family":"Chandani","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University, Karachi, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-5540-1352","authenticated-orcid":false,"given":"Ali Jawwad","family":"Karim","sequence":"additional","affiliation":[{"name":"Jinnah Sindh Medical University, Karachi, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shanza","family":"Shakir","sequence":"additional","affiliation":[{"name":"Liaquat University of Medical and Health Sciences, Jamshoro, Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,12,1]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(23)00036-4"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(13)70225-4"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.phrs.2021.105522"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-019-0226-9"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2020.09.281"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2015.15"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)30333-7"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0319606"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201907-1284OC"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003724.pub3"},{"issue":"4","key":"e_1_3_2_12_2","first-page":"352","article-title":"Narcolepsy and its treatment with stimulants. 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