HELP FOR INSOMNIA
Everyone has difficulty sleeping from time to time, but chronic insomnia can cause serious problems. A new therapy may help insomniacs fall asleep and stay asleep without the side effects of standard sleeping pills.
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About 40 million Americans suffer from insomnia.
Andrew Krystal, M.D.
Psychiatrist
Duke University Medical Center
Durham, NC
"To me, the most clear and direct effects are people not feeling as good and functioning as well."
Insomniacs are more prone to depression, health problems and accidents, especially behind the wheel.
Terry Bagley
Suffers insomnia
"That's probably the most dangerous part of being an insomniac is trying to drive long periods of time when you haven't slept in four or five days."
Terry Bagley has suffered from insomnia for more than twenty years. Over-the-counter sleep aids didn't help. In a study at Duke University's sleep lab, she took a new drug called eszopiclone. Most patients taking the drug said it helped them fall asleep faster and stay asleep longer.
Andrew Krystal, M.D.
"And, which is the most novel thing, along with all those things, there was a consistent improvement in their reports of daytime function."
Terry Bagley
"I was much more energetic. I just felt better overall."
Researchers say eszopiclone is less likely to be associated with dependence, compared to many of the older drugs used for insomnia.
Andrew Krystal, M.D.
"There is clearly a pressure on clinicians to treat the problem, and they're struggling to find an alternative."
Studies show eszopiclone is both safe and effective, and doctors say it may be the alternative they've been searching for.
The company that makes eszopiclone has submitted the results of their studies to the FDA for approval. Also, eszopiclone was studied for months, not weeks, like most insomnia drugs.
BACKGROUND: Occasional insomnia affects about 40 percent of Americans, and chronic insomnia plagues more than one in ten, according to the American Insomnia Association. There is no cure for insomnia, but it is a treatable condition. Traditionally, treatment options include medication and behavioral therapies. Behavioral treatments include relaxation therapies or stimulus control, such as decreasing caffeine intake. Prescription medicines currently available improve sleep by increasing sleep duration and reducing the number of awakenings during sleep. Over the counter medications are also available, but these medications, like some prescription medicines, have unwanted side effects and lose their effectiveness over time. Newer insomnia medications, such as eszopiclone, have been tested on a long-term basis to determine their effectiveness in treating chronic insomnia.
NEW TREATMENT, PROMISING RESULTS: A study of the drug eszopiclone, one of a new breed of compounds created to help insomnia, showed that it helped patients fall asleep faster, stay asleep longer with fewer awakenings and improved the quality of their sleep. Patients also reported feeling better during the day and reported few side effects. The placebo-controlled trial studied more than 700 people with chronic insomnia. The lead investigator of the study was Andrew Krystal, M.D., Associate Professor of Psychiatry and Director of the Sleep Research Laboratory at Duke University Medical Center. Dr. Krystal says this is a landmark study involving insomnia medications, because of its length -- six months instead of the usual 5 to 6 week studies. Of the 768 patients enrolled in the study, 573 received eszopiclone and 195 received a placebo. After six months, participants could take the active drug, as an open-label extension of the trial, for another six months, so some of the patients took the drug for a year.
A MUCH NEEDED SOLUTION: Dr. Krystal explains that most insomnia drugs are designed for only short -term use because of their addictive nature and the potential for them to be abused. Because there is some evidence that eszopiclone is less likely to be taken recreationally, it is better suited for long-term use. Unlike other drugs used to treat insomnia, eszopiclone does not lose its beneficial effects over a long period of time, decreasing the likelihood for a patient to become drug dependent and seek a higher dosage. No adverse effects were seen, including serious signs of withdrawal once the agent was stopped. Dr. Krystal says some benzodiazepines and barbiturates can produce seizures when long-term use is abruptly halted. He did not yet have information about more subtle signs signaling withdrawal, but he says no tolerance developed during the trial. The results of the study have been sent to the FDA as part of the approval process.
Duke University Medical Center
DUMC
Box 3309
Durham, NC 27710
Copyright © 2003 Ivanhoe Broadcast News, Inc.
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