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.