April 28, 2005
New Sleeping Pill Promises Long-Term Results
But one expert cautions that sleeping pills won't cure insomnia
HealthDayNews -- Insomniacs can now try another sleeping pill for desperately needed slumber.
Lunesta, from Sepracor Inc., is the latest entry into the sleep medication market, and it has the distinction of being the only such medication approved for long-term use by the U.S. Food and Drug Administration (FDA).
About 60 million Americans a year have insomnia often or for extended periods, according to the National Institute of Neurological Disorders and Stroke. Untreated chronic insomnia can lead to even more serious sleep deficits. Even so, most people with sleep problems remain undiagnosed.
According to Sepracor, which launched the sleeping medication this month, company studies found that Lunesta did not lose its effectiveness over time, and it didn't cause grogginess the next day.
But perhaps the biggest advantage touted by the company is that Lunesta can be taken for extended periods -- up to six months -- while Ambien and Sonata are recommended only for one week to 10 days. Lunesta is expected to cost about 28 percent more than Sonata and 10 percent more than Ambien, according to Sepracor estimates.
The total market for prescription sleep aids in the United States increased by 19 percent last year, to $2.1 billion. Ambien accounted for 70 percent of those sales.
One advantage to Lunesta is that studies found that no tolerance to the drug develops, and the drug is also well tolerated in older patients, said Joyce Walsleben, former director of New York University's Sleep Disorders Center. "If there are people who haven't been happy on Ambien or Sonata, this is a nice opportunity for them to try something different," she added.
Walsleben believes, however, that Ambien and Sonata can also be used for extended periods. "We all know that patients can use these drugs for long periods of time without any difficulty, and sometimes have to," she said.
For another expert, the advantage of Lunesta is that it acts in two ways.
"Lunesta treats both kinds of insomnia," said Gregg Jacobs, an insomnia specialist from the Sleep Disorders Center of Beth Israel Deaconess Medical Center. "It helps you to fall asleep and stay asleep. Ambien helps you to fall asleep, whereas Sonata helps you to stay asleep."
However, Jacobs said that Lunesta has the same problems as other sleep medications.
"Lunesta actually doesn't work that well," he said. Jacobs defines insomnia as taking 30 minutes or more to fall asleep. "When people take Lunesta for six months, they still take an average of 45 minutes to fall asleep. That's not great. It means that you still have significant insomnia," he said.
In addition, Lunesta does not cure insomnia, and it doesn't make insomnia patients normal sleepers, Jacobs added. "It only works 20 minutes faster than a placebo pill," he noted.
Jacobs is concerned with how Sepracor plans to market Lunesta. "They are going to tell patients that you can take this drug 'night after night after night.' Well, they would like you to take it night after night after night," he said.
"Because if you do that for as little as a couple of months, guess what, you're psychologically dependent on that pill, and you can't fall asleep without it," Jacobs. "They want you to become psychologically dependent upon it because you'll continue to buy it."
Jacobs noted there is no sleeping pill that needs to be taken every night. "Very few, if any, people who are going to take a sleeping pill have severe, chronic insomnia that occurs every night," he said.
Moreover, when you stop taking Lunesta, he added, your insomnia will return.
"It only temporarily treats your insomnia; it doesn't cure the causes of the insomnia, whether you take it for a couple of months or six months. When you stop taking it, your insomnia will come right back," he said. "It's a dead-end trap."
Repeated calls to Sepracor for comment were not returned.
In addition, Jacobs is worried about the long-term effects of taking sleeping pills. "We have no idea what the long-term effects are of taking a sleeping pill every night for six months or one year; we don't know what that does to brain functioning," he said.
To cure insomnia, Jacobs recommends cognitive behavior therapy, which gets to the root causes of insomnia. "I believe that short-term insomnia is most effectively treated with sleeping pills," he said. "But when you have insomnia long term, for months and years, sleeping pills are not a long-term solution."
How you become sleepy was the topic of a report in the April 21 online issue of Neuron. In experiments with rats, scientists have found a chemical released in the brain, called adenosine, is partly responsible for making you sleepy.
"We found the mechanism that links the time you've been awake to this feeling of drowsiness and the tendency to fall asleep," said lead researcher Dr. Robert W. Greene, a professor of psychiatry at the University of Texas Southwestern Medical Center. "That link is mediated by adenosine."
Adenosine is also affected by caffeine. "Part of the reason that caffeine makes you wake up is because it blocks the action of adenosine," Greene said.
Greene believes that eventually there may be clinical applications for targeting adenosine, including sleeping pills and drugs that keep you awake.
The American Insomnia Association can tell you more about insomnia.