Calcium, magnesium, potassium, and sodium oxybates oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy

Abad, Vivien C.

doi:10.1080/14656566.2023.2204187

Cited by 2 publications

(2 citation statements)

References 62 publications

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“…There exist over a dozen medications catering to narcolepsy treatment, such as modafinil and sodium oxybate 10 . Modafinil, positioned as a frontline treatment, primarily targets the brain's dopamine and norepinephrine systems.…”

Section: Introductionmentioning

confidence: 99%

“…There exist over a dozen medications catering to narcolepsy treatment, such as modafinil and sodium oxybate. 10 Modafinil, positioned as a frontline treatment, primarily targets the brain's dopamine and norepinephrine systems. It can enhance the release of the neurotransmitters, thereby boosting cognitive functions like attention, concentration, and memory with few side effects and a low risk of addiction or withdrawal.…”

Section: Introductionmentioning

confidence: 99%

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Is pitolisant safe for clinical use? A retrospective pharmacovigilance study focus on the post‐marketing safety

Jiang,

Qian,

Jiang

et al. 2024

Pharmacology Res & Perspec

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Pitolisant, a novel histamine H3‐receptor antagonist, holds significant promise for treating narcolepsy. However, a petition, which highlighted that pitolisant was associated with deaths during clinical trials, has propelled it into the spotlight of widespread societal attention on April 3, 2023. Till now, the clinical safety of pitolisant remains a heatedly debated topic. This study aimed to offer a comprehensive assessment of the safety profile of pitolisant in real‐world clinical settings. Adverse event reports where pitolisant was the primary suspect drug were extracted from the FDA Adverse Event Reporting System database. The clinical characteristics and concomitant drugs of the pitolisant‐associated adverse events were analyzed. The potential adverse event signals of pitolisant were explored using four disproportionality analysis methods. Furthermore, the difference in pitolisant‐associated adverse event signals was investigated concerning sex, age, weight, and dose. A total of 526 reports and 1695 adverse events with pitolisant as the primary suspected drug were identified. The most significant adverse event signals were generally mild and of short duration. The concomitant drugs of pitolisant were highly intricate, mainly included drugs for treating narcolepsy as well as antidepressants. Seven new significant adverse event signals emerged. The safety profile of pitolisant exhibited no significant differences across age and dose groups, although slight variations were observed in relation to sex and weight. The findings from reports of death and life‐threatening outcomes underscore the importance of enhanced monitoring for cardiac and respiratory adverse reactions when utilizing pitolisant. This study provided a broader understanding of the safety profile of pitolisant.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%