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FDA Approves New Kind of Sleeping Pill
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.
Body Boot-Down
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."
Unlike melatonin, which has widespread effects throughout the body, Rozerem sends two specific melatonin-like signals to the brain's sleep center. This reduces the alerting signal at the time a person wants to go to sleep.
"It is like shutting down a computer," Mini says. "You can pull the plug and it goes off -- that's how we see traditional sleep drugs -- but when you restart the computer, it takes a while. Or you can sign off appropriately, and let the computer boot down. We see Rozerem as letting the body boot down in normal fashion."
All that is still theoretical -- but it makes sense to David Neubauer, MD, associate director of the Johns Hopkins Sleep Disorders Center and author of Understanding Sleeplessness: Perspectives on Insomnia.
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