Pitolisant Hydrochloride Tablets: Awakening Daytime Vitality, Rebalancing Sleep-wake Balance
On June 30, 2023, China’s National Drug Administration (NMPA) formally approved Pitolisant hydrochloride tablets (Sharkos®) for the treatment of excessive daytime sleepiness (EDS) or sudden collapse in adult patients with episodic sleepiness (Narcolepsy).
Tiloxan has been recommended for the first-line treatment of episodic sleepiness in the Chinese Guidelines for the Diagnosis and Treatment of Episodic Sleeping Disorder (2022 Edition).
The core symptoms of episodic narcolepsy are excessive daytime sleepiness, sudden fainting, bedtime hallucinations, and sleep paralysis (collectively known as ‘ sleep paralysis’).
Telesis is the only drug to receive a Level I recommendation (the highest level of recommendation) and Level A evidence (the highest level of evidence) from this guideline, and the only drug to receive this recommendation and be approved for marketing in China.
As the only innovative drug approved for the indication of episodic narcolepsy in China and also the only non-psychotropic controlled drug, the launch of Pitolisant Hydrochloride Tablets (Sharkos®) will put an end to the predicament of “over-specification” and “red prescription” for patients with episodic narcolepsy in China and provide Chinese patients with safe, effective, and affordable drugs.
It will provide Chinese patients with a new safe, effective, and convenient treatment option.
Key Discovery Of Pitolisant Hydrochloride
Pitolisant hydrochloride is unique in that it targets the histamine H3 receptor, which naturally enhances alertness by modulating the histamine system within the brain, rather than simply stimulating neurotransmitters as traditional medications do.
This means that it is not only effective in combating uncontrollable daytime sleepiness but also significantly improves memory and cognitive functions, helping patients to regain normal social activities.
International Certification and Research Support
After years of rigorous testing, pitolisant hydrochloride tablets have demonstrated impressive results in a number of multi-center, randomized controlled clinical trials, which have been unanimously affirmed by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other major market regulators, proving their safety and efficacy.
Patient Voices For Pitolisant Hydrochloride
“Since starting to use Tilolisen Hydrochloride tablets, my daytime energy has significantly returned and I can focus more on my work and family life.” A beneficiary patient shared, “This is not just a drug; it is the key to restarting my normal life.”
Market Outlook and Expectations
It is expected that with the global rollout of Tilolisen Hydrochloride Tablets, the treatment landscape for patients with episodic narcolepsy will be dramatically altered, not only providing a new treatment option but, more importantly, opening a new path for them to rebuild their self-confidence and rekindle their passion for life.
As the only innovative drug approved for seizure sleep disorder in China and also the only non-psychotropic controlled drug, the launch of Tilolisen Hydrochloride Tablets (Sharkos®) will put an end to the predicament of “over-specification” and “red prescription” for seizure sleep disorder patients in China and provide Chinese patients with safe and effective treatment. It will provide Chinese patients with a new choice of safe, effective, and convenient treatment.
However, DengYueMed offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.
