The US FDA has approved the New Drug Application (NDA) of Takeda Pharmaceuticals North America, for Rozerem (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.

According to a company release, 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 designated as a controlled substance by the US Drug Enforcement Administration (DEA). With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years, and will be available for patients by late September, the release added.

Thomas Roth, director of the Sleep Disorders and Research Centre, Detroit, Michigan says, "Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain. Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day 'hangover' effects."

Yasuchika Hasegawa, president and chief operating officer of Takeda said, "The approval of Rozerem marks a major milestone for Takeda as we seek to bring innovative therapies to patients in a variety of therapeutic areas."

Approximately 60 million people in the United States suffer from insomnia, yet the vast majority remains undiagnosed and untreated. According to the US Surgeon General, nearly $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost in productivity.