Researchers at Harvard Medical School have shown that patients with chronic
sleep-onset insomnia see greater improvement from a course of
cognitive-behavioral therapy (CBT) than they do from the market-leading
hypnotic medication zolpidem (Ambien).
The study, reported in the September 27 Archives of Internal
Medicine, was a randomized controlled trial involving 63 adults with
chronic sleep-onset insomnia. The research was funded by grants from the
National Institutes of Health and National Institute on Drug Abuse.
Patients were randomly assigned to CBT, pharmacotherapy (with zolpidem), a
combination of CBT and zolpidem, or placebo. Those in the CBT group received
five 30-minute sessions over six weeks. The patients were given daily
exercises to teach them to "recognize, challenge, and change
stress-inducing thoughts," according to the study's lead author, Gregg
Jacobs, Ph.D., an assistant professor of psychiatry at Harvard and a
researcher at the Harvard-affiliated Sleep Disorders Center at Beth Israel
Deaconess Medical Center.
Patients were taught techniques such as delaying time of going to bed or
getting up to read if they were unable to fall asleep within about 20 minutes
of going to bed, Jacobs said in a press release.
Those assigned to receive zolpidem started with 10 mg a night for the first
28 nights (four weeks) of the eight-week treatment period. For the following
seven days (week 5), they received 5 mg a night, and then 5 mg every other
night for an additional week (week 6). No medication was taken during the
final two weeks.
Patients randomly assigned to receive placebo followed the same protocol as
the medication group without any CBT or "sham therapy."
Jacobs was surprised at what he and his team found.
"Sleeping pills are the most frequent treatment for insomnia, yet CBT
techniques clearly were more successful in helping the majority of study
participants to become normal sleepers. The pills were found to be only
moderately effective compared with CBT, and lost their effectiveness soon
after they were discontinued."
All patients kept sleep diaries for 14 days before treatment began, for 14
days at mid-treatment (weeks 3 and 4), and for 14 days after treatment ceased
(the end of the protocol). In addition, patients underwent three nights of
home-based "nightcap" recordings before and after treatment. The"
nightcap monitor" is a two-channel sleep monitor that measures
sleep-onset latency as well as other measures of sleep by using eyelid- and
head-movement sensors attached to a small, battery-operated recorder placed
under the bed pillow.
The CBT and the combination groups showed the greatest changes in
sleep-onset latency at mid-treatment, with both groups showing a 44 percent
reduction in the amount of time it took to fall asleep at bed time. Those
taking zolpidem showed only a 29 percent reduction, and those on placebo had
only a 10 percent reduction in sleep latency. By the end of week 8, the CBT
and combined treatment group each yielded a 52 percent reduction in sleep
onset. These significant improvements were maintained for the follow-up period
of 18 months, whereas improvements seen in the zolpidem group were not
maintained over the long term. In fact, Jacob pointed out, "by the end
of the eight-week treatment phase, insomnia returned to baseline levels and
did not differ from [those of] the placebo group."
Intriguingly, no significant differences emerged among the groups in terms
of total sleep time, though each group exhibited some increase.
"Our results suggest CBT should now be considered the first-line
treatment for insomnia, which is experienced on a nightly basis by one-third
of the nation's adult population," Jacobs concluded.
An abstract of "Cognitive-Behavior Therapy and Pharmacotherapy
for Insomnia" is posted online at<http://archinte.ama-assn.org/cgi/content/abstract/164/17/1888>.▪
Arch Intern Med20041641888