Idorsia said on Nov. 4 daridorexant (brand Quviviq) received FDA Breakthrough Therapy designation for treating insomnia disorder in children aged 10 to under 18. There is currently no FDA‑approved drug therapy for pediatric insomnia. Daridorexant was approved in China last year for adult insomnia. Simcere Pharmaceutical (02096.HK) holds exclusive Greater China development and commercialization rights.

2026-11-05

Idorsia said on Nov. 4 daridorexant (brand Quviviq) received FDA Breakthrough Therapy designation for treating insomnia disorder in children aged 10 to under 18. There is currently no FDA‑approved drug therapy for pediatric insomnia. Daridorexant was approved in China last year for adult insomnia. Simcere Pharmaceutical (02096.HK) holds exclusive Greater China development and commercialization rights.