Article: FDA Approved ROZEREM(TM) (ramelteon), First and Only Non-Scheduled Prescription Sleep Medication.

New option is the first prescription insomnia medication with a novel therapeutic mechanism of action in 35 years

LINCOLNSHIRE, Ill., July 22 /PRNewswire/ -- Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ROZEREM(TM) (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe ROZEREM for long-term use in adults.

ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been ...

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