ArticleSleep2019
Long-term use of pitolisant to treat patients with narcolepsy: Harmony III Study.
Article in Sleep, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Narcolepsy and psychosis: A systematic review.Acta psychiatrica Scandinavica · 2021Pooled it
- Pitolisant 40 mg for excessive daytime sleepiness in obstructive sleep apnea patients treated or not by CPAP: Randomised phase 3 study.Journal of sleep research · 2025Trial
- Trial
- Trial
- Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial.American journal of respiratory and critical care medicine · 2020Trial
- Histamine shapes the neurocomputational dynamics of human learning.Nature communications · 2026Article
- Narcolepsy as an immune-associated hypothalamic encephalopathy: orexin dysfunction and implications for precision sleep medicine.Frontiers in psychiatry · 2026Review
- A Comprehensive Review of Current and Emerging Treatments for Narcolepsy Type 1.Journal of clinical medicine · 2025Review
- The Future of Parasomnias.Journal of sleep research · 2025Review
- RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates.Sleep medicine: X · 2024Article
- TAK-861, a potent, orally available orexin receptor 2-selective agonist, produces wakefulness in monkeys and improves narcolepsy-like phenotypes in mouse models.Scientific reports · 2024Article
- Is pitolisant safe for clinical use? A retrospective pharmacovigilance study focus on the post-marketing safety.Pharmacology research & perspectives · 2024Article
- The Changed Nocturnal Sleep Structure and Higher Anxiety, Depression, and Fatigue in Patients with Narcolepsy Type 1.Nature and science of sleep · 2024Article
- Sleep disturbances in autism spectrum disorder: Animal models, neural mechanisms, and therapeutics.Neurobiology of sleep and circadian rhythms · 2023Review
- Orphan Drugs in Neurology-A Narrative Review.Journal of personalized medicine · 2023Review
- Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy.Sleep medicine · 2022Article
- [Real-life WAKE study in narcolepsy patients with cataplexy treated with pitolisant and unresponsive to previous treatments].Revista de neurologia · 2022Observational
- Histamine HCellular and molecular neurobiology · 2022Article
- Pharmacokinetic and pharmacodynamic assessment of histamine HEuropean journal of nuclear medicine and molecular imaging · 2022Article
- pitolisant, a novel histamine-3 receptor competitive antagonist, and inverse agonist, in the treatment of excessive daytime sleepiness in adult patients with narcolepsy.Health psychology research · 2022Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo asses the long-term safety and efficacy of pitolisant, an histamine H3-receptor antagonist, on narcolepsy.
methodsThis open-label, single-arm, pragmatic study, recruited adult patients with narcolepsy and Epworth Sleepiness Scale (ESS) score ≥12. After a titration period, patients were treated for up to 1 year with oral pitolisant once-a-day at up to 40 mg. Concomitant stimulants and anti-cataplectic agents were allowed. The primary endpoint was safety; secondary endpoints included ESS, cataplexy, and other diary parameters.
resultsPatients (n = 102, 75 with cataplexy) received pitolisant, for the first time in 73 of them. Sixty-eight patients (51 with cataplexy) completed the 12-month treatment. Common treatment-emergent adverse events were headache (11.8% of patients), insomnia (8.8%), weight gain (7.8%), anxiety (6.9%), depressive symptoms (4.9%), and nausea (4.9%). Seven patients had a serious adverse effect, unrelated to pitolisant except for a possibly related miscarriage. One-third of patients stopped pitolisant, mostly (19.6%) for insufficient benefit. ESS score decreased by 4.6 ± 0.6. Two-thirds of patients completing the treatment were responders (ESS ≤ 10 or ESS decrease ≥ 3), and one third had normalized ESS (≤10). Complete and partial cataplexy, hallucinations, sleep paralysis, and sleep attacks were reduced by 76%, 65%, 54%, 63%, and 27%, respectively. Pitolisant as monotherapy (43% of patients) was better tolerated and more efficacious on ESS than on add-on, but efficacy was maintained in this last case.
conclusionsLong-term safety and efficacy of pitolisant on daytime sleepiness, cataplexy, hallucinations, and sleep paralysis is confirmed.
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