Daridorexant receives US FDA Breakthrough Therapy designation for pediatric insomnia
November 6, 2026
Source: drugdu
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According to Simcere Pharmaceutical on November 5, the US FDA granted daridorexant Breakthrough Therapy designation for insomnia disorder in children and adolescents aged 10 to 18. The article cites study findings that the 50 mg dose showed a safety profile similar to placebo, with no drug abuse-related adverse events reported during treatment.
Daridorexant is a dual orexin receptor antagonist that suppresses wake-promoting signaling by blocking orexin A and B from binding to their receptors. In November 2022, Simcere obtained exclusive development and commercialization rights in Greater China from Switzerland’s Idorsia. China approved the drug in June 2025 for adults with insomnia characterized by difficulty falling or staying asleep.
Source: http://finance.eastmoney.com/a/202611053923706422.html
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