FDA approves a new class of sleeping pill

Filed in archive Treatment on July 22, 2005

A new prescription sleep aid has won FDA approval:

Rozerem, the first of a new kind of sleeping pill, today gained FDA approval.

Before today, many sleeping pills had potential narcotic-like effects. True, new nonbenzodiazepine sleeping pills -- such as ambien, Lunesta, and Sonata -- have greatly reduced abuse potential. But they still have a sedating effect throughout the brain. And like earlier sleep drugs, they are controlled substances under federal law.

Rozerem (8-milligram tablets) is the first and only noncontrolled prescription medication for use of insomnia in adults. It is prescribed for insomnia characterized by difficulty with sleep onset.

Rozerem can be prescribed for long-term use. The medication has shown no evidence of abuse and dependence, according to a news release by Takeda Pharmaceuticals North America, the drug's maker.

Studies have shown that cognitive therapy works better than sleep pills, but in today's world, everybody wants instant gratification. (DeNoon, "FDA Approves New Kind of Sleeping Pill", WebMD, Jul.22)