What are the side effects of Pitolisant-wakix?

Pitolisant (Pitolisant) - The most common side effects of wakix in adults are insomnia (trouble sleeping), headache, nausea, anxiety, irritability, dizziness, depression, tremor, sleep disturbance, fatigue, vomiting, vertigo (spinning sensation), and indigestion (heartburn). Serious but rare side effects are abnormal weight loss and spontaneous abortion. Symptoms of tilolixan overdose may include headache, insomnia, irritability, nausea, and abdominal pain. After tilorisen tablets were put on the market, adverse events such as allergic reactions, itching, weight gain, epilepsy, abnormal behavior, abnormal dreams, anhedonia, bipolar disorder, depression, depressed mood, nightmares, sleep disorders, suicide attempts, and suicidal ideation have also occurred.

In animal experiments, after 1 month of oral administration to mice, 6 months after oral administration to rats, and 9 months after oral administration to monkeys, the no-adverse-effect levels (NOAEL) were 75, 30, and 12 mg/kg/day respectively. Pidoride was not found to be genotoxic in the Ames test, and tilolixen tablets were not found to be carcinogenic in mouse and rat carcinogenicity studies. In teratogenicity studies in rabbits and rats, high maternally toxic doses of tilolixen tablets caused abnormal sperm morphology and reduced motility in male rats without any significant effect on fertility index. It also reduced the percentage of viable embryos and increased post-implantation losses in female rats. Delayed postnatal development is observed.

Tilorisen tablets have been marketed in the country, but have not yet been included in medical insurance. The price of each box of the original version of tilorisen tablets marketed overseas may be over more than RMB 4,000 (the price may fluctuate due to exchange rates). Currently, there are no generic versions of tilorisen tablets produced and marketed overseas.