Relaxation Better Than Drugs for Insomnia

By Michael Smith
SOURCE: MedPage Today

Relaxation and other behavioral techniques may overcome insomnia better than drugs, found investigators here.

A randomized, placebo-controlled trial comparing the hypnotic agent Imovane (zopiclone) with cognitive behavioral therapy found that for most outcomes, Imovane was no more effective than placebo, the researchers reported in the June 28 issue of the Journal of the American Medical Association.

On the other hand, cognitive behavioral therapy was significantly better than either, said Børge Sivertsen, Psy.D., of the University of Bergen, and colleagues.

Imovane is not approved in the U.S., although Lunesta (eszopiclone)—a version of the medication containing only the active isomer—was approved in 2004.

In older adults with chronic primary insomnia, "cognitive behavioral therapy was more effective immediately and long-term compared with both zopiclone and placebo," Dr. Sivertsen and colleagues concluded. However, they noted, the finding might not generalize to all sleep medications.

Despite that limitation, they argued, the results imply that physicians should be cautious in prescribing hypnotics for long-term use, given increasing evidence of the long-term efficacy of cognitive behavioral therapy and the lack of similar evidence for the medications. "Clinicians," they wrote, "should consider prescribing hypnotics only for acute insomnia."

The researchers enrolled 46 adults, 55 or older, with chronic primary insomnia that had lasted at least three months and affected their daytime functioning. The participants were randomized to get Imovane, a placebo resembling Imovane, or cognitive behavioral therapy, which included sleep hygiene education, sleep restriction, stimulus control, cognitive therapy, and progressive relaxation techniques.

Outcome measures were total wake time, total sleep time, sleep efficiency, and slow-wave sleep. The effects of the therapies were assessed with ambient clinical polysomnography, supplemented with sleep diaries; assessments of all three groups were made at baseline and at six weeks, and again at six months for the two active groups.

The study found:

Total wake time at six weeks was reduced 52% for cognitive behavioral therapy, compared with 4% and 16% for Imovane and placebo respectively; Imovane and placebo were not significantly different, while cognitive behavioral therapy was significantly better at P<0.001. Cognitive behavioral therapy remained significantly better than Imovane at six months (P=0.001).
Total sleep time showed no differences between groups at any point.
As measured by polysomnography, sleep efficiency was improved by 9% at six weeks for the cognitive behavioral therapy group, compared with minus-one for Imovane and minus-three for placebo. The difference was significant (at P=0.004) for cognitive behavioral therapy over placebo, but not for cognitive behavioral therapy over Imovane or Imovane over placebo.
As measured by diaries, sleep efficiency improved in all groups, but there were no group differences.
The amount of slow-wave sleep recorded by polysomnography improved significantly at six weeks for cognitive behavioral therapy over both the placebo (P=.03) and Imovane groups (P=.002). Patients getting Imovane had a significant (P=0.01) reduction in slow-wave sleep compared to baseline.

At the six-month follow-up, total sleep time for the cognitive behavioral therapy patients continued to improve, while there were no changes in the Imovane group.

The clinical significance of the effect in the two active arms was assessed using the proportion of participants who reached a sleep efficiency level, measured by polysomnography, of at least 85%. At six weeks, 13 people in the cognitive behavioral therapy group (72%) reached that mark, and 14 (78%) reached it at six months. By comparison, seven (47%) of the Imovane group reached the mark at six weeks and six (40%) at six months.

The researchers noted that the study was not perfectly blinded, since the cognitive behavioral therapy group was clearly different from the two groups taking pills, and the study groups were relatively small.

They also pointed out that only those with chronic primary insomnia were included, and thus, the results may not generalize to patients whose sleep problems are secondary to psychiatric or medical conditions. In addition, they said "it remains to be seen whether cognitive behavioral therapy for insomnia may yield similar positive results in primary care settings, in which sleep problems may be part of a more complex clinical picture. "

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