Japan-based drugmaker Eisai Co’s US subsidiary announced on Sunday that it had received approval from the US Food and Drug Administration for its insomnia treatment in adult patients.
The agency approved the drug, Dayvigo, in doses of 5 mg and 10 mg based on two late-stage studies testing the drug in patients with insomnia versus placebo for up to one month and six months, the drugmaker’s U.S. subsidiary said.
The treatment belongs to a new class of medications, which target the orexin system, joining the ranks with Merck & Co’s Belsomra, which was approved in 2014.
Dayvigo acts on the neurotransmitter system in the brain to suppress the wake drive, as opposed to existing prescription insomnia medicines, which target the sleep centers of the brain to increase the sleep drive, Eisai said.
FDA has recommended Dayvigo to be classified as a controlled substance because it can be addictive and has the potential to be abused. The recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA), the company said.