Oct. 22, 2003 -- Taking a pill every night may be a safe and effective way for insomniacs to fall asleep faster and stay asleep longer for months or even years at a time.
The first major study to look at the long-term effects of using a drug to treat insomnia suggests that the latest generation of insomnia drugs can provide long-term relief from sleepless nights -- without losing their effectiveness over time.
"That combination -- improvement in all areas of falling asleep, staying asleep, and quality of sleep, along with an improvement in daytime functional ratings -- has never been reported in a study, let alone for six months," says researcher Andrew Krystal, MD, MS, associate professor of psychiatry at Duke University Medical Center in Durham, N.C.
Although as many as a quarter of the estimated 2.5% of Americans who suffer from insomnia use insomnia medications on a nightly basis for four months or more, researchers say that until now there were no studies to show that long-term use of these drugs was either safe or effective.
Treating Insomnia Over the Long Haul
Estorra belongs to a class of drugs used to treat insomnia known as hypnotics and is currently under consideration for approval by the FDA. Other drugs in this class that are currently available for short-term treatment of insomnia include Sonata and Ambien.
Researchers say long-term use of insomnia medications has been traditionally discouraged for several reasons. For example, there were concerns that people might develop a tolerance for the drugs and they'd lose their effectiveness, or people might misuse or abuse the drugs.
But this study, which appears in the Nov. 1 issue of Sleep, showed that the drug provided about the same relief after six months of use as after the first week of treatment.
"It demonstrates that at least [Estorra] and probably other medications don't result in development of tolerance as is commonly assumed," says researcher James K. Walsh, PhD, senior scientist at the sleep medicine and research center at St. John's/St. Luke's Hospitals in St. Louis.
The study compared the effectiveness of nightly treatment with Estorra with a placebo in a group of 788 people with insomnia not caused by other health problems, such as depression or anxiety. They reported less than 6.5 hours of sleep a night or taking longer than 30 minutes to fall asleep for at least one month before the study began.
Researchers found improvements in three major insomnia symptom areas:
- Ability to fall asleep. After one week of treatment, the average time it took to fall asleep was 30 minutes among Estorra users vs. 60 minutes for the placebo. After six months, the average times were 30 and 45 minutes, respectively.
- Sleep quality. Reductions in the number of awakenings per night and number of nights patients were awakened during sleep were lower among Estorra users vs. the placebo at every time point.
- Sleep quantity. Estorra users slept an average of 30-40 minutes longer per night compared with those who received the placebo.
The study also found that people with insomnia who took Estorra said they functioned better, felt more alert, and had a higher sense of physical well-being during the day compared with the others.
Study Opens Door to More Insomnia Research
Sleep experts say this study represents a landmark in insomnia treatment studies."It was an important study mainly because of what they did rather than what they did it with," says Daniel Buysse, MD, professor of psychiatry at the University of Pittsburgh School of Medicine. "The fact that Estorra was the drug used, to me, wasn't nearly as important as the fact that someone finally did a study of treating insomnia with a medication for six months of continuous nightly use. I think that is a very important advance in the treatment of insomnia."
Buysse, who also wrote an editorial that accompanies the study, says it's likely that other insomnia drugs, such as Ambien and Sonata, if tested over the long term might also continue to have effects similar to those shown during short-term use.
Although this study resolves one major issue about the long-term treatment of insomnia, Buysse says that it also raises several others that will have to be addressed in future studies, such as whether or not daily treatment is needed and whether long-term treatment of insomnia lowers other health risks.
Krystal agrees and says this is only the first study to look at the issue of long-term treatment of insomnia in a large group of adults, and many more questions remain.
"Now that we can treat people for a while," Krystal tells WebMD, "we can then start asking the question what happens when we stop it, do people still have disease, who are they, and how do we know who should continue and who shouldn't?"