FDA OKs New Insomnia Drug

The government approved a new treatment for insomnia Friday, the first prescription sleep aid not designated as a controlled substance.

Called Rozerem, the drug works differently than its competitors. It is chemically related to the natural hormone melatonin, which helps regulate the body’s sleep-wake cycle, and is thought to work by stimulating melatonin receptors in the brain, said Dr. Robert Meyer of the Food and Drug Administration.

“It’s another option” for people with the main form of insomnia, difficulty in falling asleep, Meyer said. “By working through a different pathway, it’s entirely possible that this might work for some people in ways that the other drugs do not.”

Studies show no signs that Rozerem, known chemically as ramelteon, causes dependence, the reason it was not designated a controlled substance.

The main warning: Rozerem is metabolized by the liver, so people with liver problems shouldn’t take it, Meyer said

Manufacturer Takeda Pharmaceuticals said Rozerem would be available in late September but would not reveal a price.

Almost a third of adults have trouble sleeping, and about 10% have the symptoms of daytime impairment that signal true insomnia. Rozerem joins a list of newer prescription sleep pills that work without many of the side effects of older agents.