Comprehensive Report: Suvorexant (Belsomra)

Executive Summary & Drug Profile

Overview and Place in Therapy

Suvorexant, developed and produced by Merck & Co. under the brand name Belsomra, is a first-in-class small-molecule hypnotic agent.[1] It represents a significant advancement in the pharmacotherapy of sleep disorders, belonging to a novel class of drugs known as dual orexin receptor antagonists (DORAs).[2] Its primary indication is for the treatment of insomnia in adults, specifically addressing difficulties with both sleep onset (falling asleep) and sleep maintenance (staying asleep).[1]

The therapeutic distinction of suvorexant lies in its unique mechanism of action. Unlike traditional hypnotics that induce global central nervous system (CNS) depression, suvorexant selectively targets and inhibits the orexin neuropeptide system, a key regulator of wakefulness and arousal in the brain.[7] By suppressing the "wake drive," suvorexant facilitates the natural transition to sleep rather than inducing sedation through broad inhibitory pathways.[4] This targeted approach offers a different risk-benefit profile compared to older agents, particularly concerning the potential for physical dependence and withdrawal.

In the United States, suvorexant is regulated as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA), a classification that reflects a recognized medical use and a low potential for abuse and dependence relative to substances in Schedule III.[9] Its introduction has provided clinicians with an alternative for patients who cannot tolerate or do not receive adequate benefit from traditional sleep agents, such as benzodiazepine receptor agonists.[3]

Chemical and Physical Properties