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
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.