New Rx Sleep Drug: Promising or Perilous?

iStockphotos/Thinkstock(NEW YORK) -- Your eyes snap open, but the room is dark and the alarm clock reads 2 a.m.

It's a frustrating but all-too-familiar scenario for many. A new sleep aid called Intermezzo, available in pharmacies with a prescription starting on Thursday, aims to address this problem. The Food and Drug Administration approved Intermezzo in November, but some physicians have questioned its usefulness and safety.

Forty-two percent of Americans reported waking up in the middle of the night, according to the 2008 Sleep in America Poll conducted by the National Sleep Foundation, and 29 percent said they found it difficult to fall back to sleep. Known as middle-of-the-night insomnia, it is the most common form of insomnia, the survey reported. Other sleep aids on the market were designed to be taken before falling asleep, and work for eight hours, which is great if your problem is not being able to get to sleep but not so great if you wake up at, say, 3 a.m., and have only a few hours left of shut-eye.

Purdue Pharma, the company behind Intermezzo, said the new pill could be taken by those who wake up mid-sleep and may have only four hours or so left to doze. This makes it the only FDA-approved drug for middle-of-the night insomniacs. The drug contains zolpidem tartrate, the same active ingredient in the popular prescription sleep aid Ambien, but at a lower dose. It is also taken in a different way. Whereas Ambien is swallowed, Intermezzo is left to dissolve under the tongue, so it works more quickly.

But some doctors said Intermezzo's side effects may be considerable. Since the drug is in the same class as previous sleep aids, it carries with it all of the same potential side effects, including behavioral disturbances, sleep walking and possible worsening of depression or suicidal thoughts.

Worry that the drug could negatively affect a person's ability to drive in the a.m. held up FDA approval of Intermezzo for roughly two years. In highway driving studies conducted in 2010, those who had taken Intermezzo were found to be impaired for up to three hours. Driving was deemed safe at the four-hour mark, although there was still a small difference between drivers who'd taken the drug and those who had not.

"I would probably use this drug in patients who not only had four hours of sleep remaining but could also afford to wait an additional one to two hours before driving," said Dr. Stanley Wang, a cardiologist and director of the Sleep Disorders Center at Heart Hospital of Austin in Texas, in an email to ABC News.

Whether having Intermezzo on the market will lead to more consumption of prescription sleep drugs is a matter of debate. In 2010, medications containing zolpidem tartrate, the most common ingredient in sleeping aids, were collectively the 15th most-popular prescription drug in the country, with more than 38 million prescriptions dispensed, according to pharmaceutical data firm IMS Health.

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