New Rx Sleep Drug: Promising, or Perilous?

Intermezzo could help those who wake in the night, but some doctors cautious.

ByJESSICA NOONAN, M.D., ABC News Medical Unit
April 4, 2012, 5:09 PM

April 4, 2012— -- 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. But Intermezzo, a new prescription sleep aid that hits pharmacies on Thursday, promises some relief.

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 are supposed 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 as little as four hours or so left to doze. This makes it the only Food and Drug Administration approved drug for middle-of-the night insomniacs.

Intermezzo 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.

"It fills a niche that is the bane of practitioners everywhere, the patient who can fall asleep without difficulty but wakes up in the middle of the night," said Dr. Joe Lieberman, who is currently working with Purdue to promote Intermezzo.

But some physicians have questioned Intermezzo's usefulness and safety. Since the drug is in the same class as previous sleep aids, it carries with it all 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 four hours after taking the drug, 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.

Will Intermezzo Mean More People on Sleep Drugs?

Dr. Nanci Yuan, medical director of the Pediatric Pulmonary Sleep Center at Lucile Packard Children's Hospital at Stanford, said she worried that this number could increase once Intermezzo came on the market.

"Prescribers may order this 'lower-safer' formulation more readily to anyone with a sleeping problem than they would for standard Ambien," she said in an email to ABC News.

Other experts, however, said Intermezzo would cut down on the use of sleeping aids, since the drug is used only as needed and not every night.

"Currently, people are stuck with making a decision at the beginning of the night if they want to have a great night's sleep or a terrible one, so they take the drug even though they might not need it," said Thomas Roth, director of the sleep center at Henry Ford Hospital. Roth was involved in the research for Intermezzo.

Of course, sleep aids are not the only solution for many who wake up in the middle of the night. A number of underlying conditions are thought to worsen middle of the night awakening -- psychiatric disorders, chronic pain, obstructive sleep apnea, obesity, hypertension, heart disease, menopause and prostate problems among them.

Treating these conditions often leads to resolution of sleeping problems without the need of sleep aids. In other cases, something as simple as cutting down on alcohol consumption before bed may help improve sleep. While alcohol can help in falling asleep initially, it makes it more difficult to enter deeper stages of sleep.

Anxiety is also linked to waking up in the middle of the night. People worry about the effects of not getting enough sleep, and this anxiety quickly jumps to other areas of life, leading to increased arousal. Experts usually recommend behavioral changes to cut down on anxiety and stimulation before sleep.

When prescription sleep aids are necessary, the first bit of advice is always the same -- check with your doctor.

"In medicine, we constantly weigh the cost and the benefit to make the best decision, and the decision to use Intermezzo will be no different," Lieberman said. "Careful patient education will remain one of the most important factors."

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