Takeda Gets FDA Approval for New Sleeping Pill

Jul. 23–TOKYO — Takeda Pharmaceutical Co. said Saturday its U.S.-based research and development center has received approval from the U.S. Food and Drug Administration for a new prescription insomnia medicine.

Rozerem, which is generically known as ramelteon and comes in 8-milligram tablets, is the first product of its kind that has shown no evidence of abuse and dependence and therefore has not been designated as a controlled substance by the Drug Enforcement Administration, the major Japanese pharmaceutical company said.

Takeda will market it in the United States through its U.S. unit, it said, without giving a timetable.

According to Takeda, ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process.

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