New Insomnia Drug Offers Lasting Relief
Long-Term Insomnia Treatment Safe and Effective
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.
Researchers found that nightly use of an experimental new
insomnia drug called Estorra not only helped insomniacs sleep better at night,
but it also helped them function better during the day.
"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.
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
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,
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.