FDA Approves New Kind of Sleeping Pill

Rozerem First Drug to Target Brain's Sleep Center

From the WebMD Archives


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.

"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."