Daridorexant Hydrochloride Market

The Daridorexant Hydrochloride market is expected to grow at a 7.1% CAGR from 2025 to 2035, driven by rising demand for improved orexin receptor antagonists in the treatment of insomnia and other sleep-related diseases.  As a hydrochloride salt of Daridorexant, this API has improved solubility, stability, and pharmacokinetic performance, making it more appropriate for large-scale formulation techniques in current CNS drug development. This chemical is quickly gaining popularity due to its dual mechanism that targets both OX1R and OX2R, providing a targeted approach to modulating the sleep-wake cycle without causing sedation, dependence, or impaired cognition. The clinical preference for DORAs (Dual Orexin Receptor Antagonists) over standard GABA-A modulators supports Daridorexant Hydrochloride’s role in the replacement of earlier treatment methods. Its positive profile in senior populations, who are especially prone to the negative effects of traditional hypnotics, provides a strategic business advantage.

Geographically, North America dominates the Daridorexant Hydrochloride market, thanks to a high incidence of chronic insomnia, robust regulatory approvals, and physician education on orexin-based therapy. The United States accounts for the majority of commercial usage following FDA approval of Daridorexant-based products. Europe follows closely, supported by EMA regulations, expanding sleep clinics, and integration of orexin antagonists in neurology protocols. The Asia-Pacific region is witnessing a surge in demand due to urban lifestyle stressors, rising diagnosis rates, and growing interest in novel CNS therapies. Markets such as South Korea, Japan, and India are investing in sleep health infrastructure and local formulation capabilities. Meanwhile, Latin America and MEA are developing through telehealth adoption and increasing mental health literacy.

The Daridorexant Hydrochloride market is being strengthened through technological partnerships between CNS-focused biotech firms, CDMOs, and excipient developers. There is a strong emphasis on API crystallinity control, salt purity optimization, and polymorph screening to meet the unique demands of DORAs in controlled-release systems. Sustainable synthesis practices and API yield enhancement are key R&D goals. Furthermore, the emergence of digital therapeutics, sleep-tracking tools, and direct-to-patient delivery models is expanding commercial use cases for Daridorexant Hydrochloride. Together, these factors are shaping a highly specialized and rapidly advancing segment within the sleep therapeutics API market.