FDA Approves New Kind of Sleeping Pill
Rozerem First Drug to Target Brain's Sleep Center
July 22, 2005 -- Rozerem, the first of a new kind of sleeping pill, has been approved by the FDA.
Before this approval, 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.
Rozerem is different from other sleep drugs. It targets specific switches in the part of the brain that regulate sleep, a group of brain cells located in an area of the brain called the SCN. By flipping these switches -- called melatonin receptors -- Rozerem takes the brakes off the body's natural sleep drive.
Here's how it's thought to work. The body has a sleep drive as well as a waking drive. As the day wears on, the sleep drive builds up. But it doesn't make you fall asleep in the daytime, because that's when the waking drive is stronger. Later in the evening, the waking drive winds down while the sleep drive continues to build up. By bedtime, the sleep drive is stronger -- and you're ready for normal sleep.
If you've got insomnia, the sleep and waking drives get out of balance. Most sleeping pills work by enhancing the sleep drive. Rozerem seems to work by relaxing the waking drive, says psychiatrist Louis J. Mini, MD, Takeda North America's medical director for neuroscience.
"In people who sleep normally, the pineal gland in the brain responds to darkness by producing a hormone called melatonin," Mini says. "This natural melatonin ... dampens the alerting signal so the sleep load overrides [the waking drive] and allows a person to fall asleep."