Searching for the ‘Perfect’ Sleep Aid
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Searching for the ‘Perfect’ Sleep Aid
FDA considers new formulas

(HealthDay News) - If you have trouble sleeping, you're in good company.
Approximately 70 million Americans have some form of sleep disorder, from difficulty falling asleep to waking up too early, according to the National Sleep Foundation. Most people who have trouble sleeping never seek medical attention, the group says.

That's a trend the pharmaceutical industry would like to change. Sleep aids have become big business. A recent Business Week article said the market for sleep drugs is projected to balloon to $5 billion in 2010 from $2.5 million today.

Some critics argue that drug makers have largely created the market for sleep aids, and that people don't need medication to overcome insomnia.

"They're wrong," says Dr. Tom Roth, director of the sleep disorders center at the Henry Ford Hospital in Detroit.

While it's true that not everyone with insomnia requires sleep aids or should take them, for many patients the drugs are essential. The drugs are the most common treatment insomnia, according to the National Sleep Foundation. One in four Americans takes some kind of medication for sleep in any given year, the group says.

On the other hand, Roth says, there's no conclusive evidence that drugs work better than non-drug sleep aids, like shifting bed and wake times or altering the way a person thinks about sleep.

What’s on the market

Valium and Xanax were perhaps the best-known prescription sleeping aids for years. These medications belong to a family of drugs called benzodiazepines. They're effective for insomniacs, but they carry the risk of serious side effects, including depression, aggression and memory trouble. They're also habit forming and long-term use can lead to tolerance of the drugs.

The benzodiazepines have been pushed aside by two new prescription drugs, Ambien and Sonata, which now dominate the market for sleep aids. Neither is a benzodiazepine, though they're not free of side effects.

Ambien, made by Sanofi-Synthelabo, can cause daytime drowsiness, dizziness, lightheadedness and difficulty with coordination. Furthermore, the drug's manufacturer doesn't recommend operating machinery or performing tasks that take extreme coordination.

Sonata, from Wyeth-Ayerst Laboratories, has the same side effects as Ambien. It doesn't appear to be effective in increasing a patient’s total sleep time as its competitor. Nor does sonata decrease the number of times a patient may wake up after falling asleep.

Scientists don't know yet if Ambien and Sonata are addictive, or whether they continue to work over time. Doctors recommend that patients take the drugs nightly only for insomnia that lasts a week or two.

The newcomers

Two new sleep drugs are expected to win regulatory approval in the near future. One is
eszopiclone, or Estorra, from Sepracor. The other is Indiplon, from Neurocrine Biosciences, Inc.

Both Indiplon and Estorra are based on the same chemical structure as Ambien and Sonata, so patients should expect similar side effects from the new drugs, if they're approved, Roth says. "I know of know drug in any arena which is free of side effects," Roth says. "That's the nature of drugs."

Joyce Walsleben, director of the Sleep Disorders Center at the New York University School of Medicine, in New York City, says of the prospective new drugs: "My thinking is, the more the merrier. Not every drug is right for everyone."

Walsleben believes that modifying sleeping behavior is ultimately a more solid solution to sleeping disorders than medication. "There's evidence that's behavior therapy is better over the long term. But the combination [of drugs and habit change] is really great," she says. And "clearly, there are times when medication is the only way to go."

In her own clinic Walsleben sees "very few" side effects from Ambien and Sonata. Sonata doesn't always work, however, and Ambien occasionally leads to confusion. "If you're up and about with any sedative on board, you're likely to forget what you're doing," she adds.

Over-the-counter medications

Many people with sleeping trouble look to over-the-counter and "natural" remedies for help. But Dr. Richard Schwab, co-director of the sleep center at the University of Pennsylvania Medical Center, in Philadelphia, says people who do turn to these products should do so with caution.

"In my experience, prescription sleep aids are much more effective than over the counter sleep aids" such as those with benadryl and melatonin. Benadryl has a long half-life, meaning it sticks around in the body for a long time. It also can make urination difficult, a particular problem for older insomniacs.

As for melatonin, despite the hype there's little hard evidence that the substance works as advertised, Schwab says. "We don't know what the right dose is," he says.

What's more, since it's regulated as a diet supplement and not a drug, consumers have no guarantee of purity when they buy a melatonin product. "It could be processed from an animal, for example," raising potential fears about "mad cow" disease or other illnesses that can jump to humans from animal tissues.

Schwab prescribes Ambien, Sonata and the drug temazepam--a benzodiazepine sold as Restoril--to his patients with insomnia. He also advocates behavior therapy, though that approach takes "a lot of time. You need a physician or a psychologist to sit down and meet weekly or bi-weekly" for months to change poor sleep habits, he says.

Many insomniacs aren't able to change their sleeping behavior for the better. These people likely have a genetic predisposition to poor sleep, Schwab says, since chronic insomnia often runs in families.

For these patients, doctors may have no choice but to prescribe sleep aids for years, if not decades. Although there's no evidence about the long-term safety of drugs like Ambien and Sonata, Schwab says in his own practice he hasn't run into problems. "Assuming they have no underlying problems like depression, that behavior therapy has failed and they tolerate the drug well, with no side effects or changes in memory, then I feel comfortable," he says. "It's just like giving someone medication for high blood pressure."

On the Web

The National Sleep Foundation has an excellent explanation as to why people can’t sleep.


SOURCES:
Article, Business Week, Jan. 26, 2004;
Interview, Dr. Tom Roth, director, Sleep Disorders Center, Henry Ford Hospital, Detroit, Mich.;
interview, Dr. Richard Schwab, co-director, the sleep center at the University of Pennsylvania Medical Center, Philadelphia
Publication date: May 17, 2004
Author: Adam Marcus, HealthDay Reporter
Copyright © 2004 ScoutNews, LLC. All rights reserved.

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