FDA Approves New Kind of Sleeping Pill
Rozerem First Drug to Target Brain's Sleep Center
"It is clear that something critical is happening at the end of waking
time so the body lets us transition rather rapidly from being awake to being
asleep," Neubauer tells WebMD. "A lot of this has to do with the SCN.
And as [Rozerem] targets melatonin receptors in the SCN, it makes sense it can
make a gearshift toward sleep."
What Sleep Doctors Say
Is Rozerem going to affect the way doctors treat patients?
"I am delighted to have another thing to offer to my patients,"
Neubauer says. "There will be a lot of interest. One -- because it is the
first sleep drug in a very long time to have a new mechanism of action. And two
-- I think there is going to be a very high comfort level in prescribing this
drug. The safety level is extremely positive. A lot of doctors -- and a lot of
patients who haven't been interested in a sleeping pill -- may view this in a
different light and may be more comfortable giving it a try."
But Milton Kramer, MD, isn't sure Rozerem is going to be better than
existing sleeping pills. Kramer is director of psychiatric research, Maimonides
Medical Center, Brooklyn, N.Y.
"I don't think [Rozerem] is going to have an enormous impact,"
Kramer tells WebMD. "The issue is around the size of the change it
accomplishes -- its effectiveness in chronic [sleeping-pill] users is not
enormous. But people may see it as being a more 'natural' substance, and that
may give it tremendous appeal."
Rozerem should be taken within 30 minutes before going to bed. It should not
be taken with or immediately after a high-fat meal. Engaging in hazardous
activities that require concentration (such as operating a motor vehicle or
heavy machinery) after taking Rozerem should be avoided.
The most common side effects seen with Rozerem were somnolence, dizziness,
and fatigue. Rozerem should not be used in people with severe liver
Rozerem vs. Melatonin
So wouldn't over-the-counter melatonin supplements work as well as Rozerem?
No, Mini says. Rozerem has a more potent effect on the sleep center of the
brain than melatonin supplements. And unlike the supplement, Rozerem has been
tested in well-designed studies.
"If you look at the melatonin data, and the recent NIH consensus panel
statement, it says that there is little evidence to support the use of
melatonin for the treatment of insomnia," Mini says. "And even at that,
the dose needed for sleep promotion is unclear. Strict clinical trials of
melatonin have not been done. It is an unregulated supplement."
According to the Takeda news release, Rozerem will be available for patients
by late August.