Daridorexant Hydrochloride COA

Daridorexant Hydrochloride is a high-purity active pharmaceutical ingredient (API) of Daridorexant, a novel, clinically validated dual orexin receptor antagonist (DORA) exclusively developed for the treatment of adult insomnia disorders. As a selective and equipotent antagonist for both OX1 and OX2 orexin receptors, it works by competitively blocking the binding of wake-promoting orexin A and orexin B neuropeptides in the human hypothalamus, effectively suppressing excessive neuronal wakefulness drive rather than non-specifically sedating the central nervous system.

Compared with traditional benzodiazepine and Z-drug hypnotics, Daridorexant Hydrochloride features superior safety and tolerability. It regulates sleep initiation and sleep maintenance without disrupting normal sleep architecture, preserving natural sleep cycles and reducing common side effects such as daytime drowsiness, drug dependence, and rebound insomnia. The finished drug product branded as Quviviq obtained FDA approval in 2022 and has been authorized for clinical use in major global regions, indicated for patients with difficulty falling asleep and maintaining sleep.

In physical properties, Daridorexant Hydrochloride appears as an off-white to pale yellow crystalline powder with stable chemical properties under standard storage conditions. Metabolized mainly via the CYP3A4 pathway, it exhibits predictable pharmacokinetic performance and low drug‑drug interaction risks. Currently, this innovative molecule is widely adopted in global generic formulation development, clinical trial research, and pharmaceutical registration projects, making it a high-potential new insomnia API for international pharmaceutical manufacturers.

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