New Insomnia Drug Gets FDA Approval

BOSTON -- If you're one of the 60 million Americans who have trouble getting a good night's sleep, there will soon be a new option for you.

The Food and Drug Administration recently approved Rozerem -- the first insomnia drug not classified as a controlled substance, which means it can be prescribed for long-term use, reported WCVB-TV in Boston.

The drug joins an already crowded field of prescription sleep aids, but all of the existing drugs have the potential to become addictive and are classified as controlled substances by the FDA.

Rozerem is the only federally approved prescription sleep aid that has no risk of becoming addictive. It is chemically related to the natural sleep hormone melatonin and works by targeting two receptors in the part of the brain that regulate the body's master clock.

It will be available by prescription this fall.

"Rozerem really does represent a breakthrough in the treatment of insomnia," said Dr. Mark Zimmerman, of Brown University Medical School in Providence, R.I.

For nearly two years, nighttime was a nightmare for Alicia Velez.

"Up every hour. You look at the clock, it's 2:45 a.m., you wake up again it's 3:40 a.m., you wake up again it's 4:30 a.m.," Velez said.

She went to her doctor for help, but she was concerned about taking a prescription sleep aid.

"The Ambien, I was really nervous about because it can be habit-forming," Velez said.

"All other medications that are prescribed for insomnia are central nervous system depressants," Zimmerman said. "They essentially act like alcohol does. That's not true of Rozerem."

The new competition has other drug companies stepping up their advertising. Nearly $50 million was spent on ads for sleep aids in just the first four months of this year.

Dr. Sanford Auerbach, a sleep expert from Boston University, said that the marketing is helping to educate a public that often doesn't realize the extent of its sleep problems.

"It does highlight the fact that people should pay attention to their sleep, that they should address these issues with their physicians that it is important to get a good night's sleep," Auerbach said.

Doctors say some patients respond better to some medications than others, and this new drug will give them another treatment option.