Is pitolisant a psychotropic drug?
Nov 21, 2025
Source: Cainiu Health
Dr. Zhang Baohua
Introduction
Tilorone is a selective histamine H3 receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons, thereby increasing the synthesis and release of histamine—a neurotransmitter that promotes wakefulness in the brain—and improving patients' alertness and wakefulness. This drug is primarily used to treat narcolepsy, a rare disorder characterized by excessive daytime sleepiness.
Generally, pitolisant falls within the category of psychotropic medications, but it is not classified as a controlled psychotropic substance under traditional definitions. If you have any questions about its use, it is recommended to consult a physician in advance. The detailed analysis is as follows:
Pitolisant is a selective histamine H3 receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons, thereby increasing the synthesis and release of histamine—a neurotransmitter promoting wakefulness—in the brain. This mechanism improves patients' alertness and wakefulness. The drug is primarily used to treat narcolepsy, a rare neurological disorder characterized by excessive daytime sleepiness.
Although pitolisant shares some mechanistic similarities with psychotropic drugs, it is not indicated for treating psychiatric disorders such as anxiety or depression. In China, it is categorized as a non-controlled psychotropic medication. However, patients with a history of severe psychiatric conditions, including severe anxiety or depression with suicidal ideation, should use this medication cautiously.
During treatment with pitolisant, it is essential to strictly follow medical instructions, attend regular follow-up visits to evaluate efficacy and safety, and avoid adjusting the dosage or discontinuing the medication without medical guidance, to prevent compromising therapeutic outcomes.
