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‘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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