Counseling is Better than Drugs for Chronic Insomnia

Abstract & Commentary

By Mary Elina Ferris, MD, Clinical Associate Professor, University of Southern California. Dr. Ferris reports no financial relationship to this field of study.

Synopsis: Chronic insomnia in older adults improved more with objective measures when treated with cognitive behavioral therapy rather than nightly medications.

Source: Sivertsen B, et al. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA. 2006;295:2851-2858.

Clinical psychologists in Norway conducted a randomized, double-blinded, placebo-controlled trial comparing cognitive behavioral therapy and the non-benzodiazepine sleep medication zopiclone. Treatment duration was 6 weeks with follow-up at 6 months. Forty-six adults with a mean age of 61 years were involved. Approximately half of the participants were women. Eligibility requirements were at least 3 months of insomnia with impaired daytime functioning, symptoms fulfilling DSM-IV criteria for insomnia, and no presence of sleep apnea or periodic limb movements during sleep, no use of medications for insomnia, depression or psychosis, and no other serious somatic conditions.

Ambulant polysomnography (PSG) in participants' homes for 2 consecutive nights was part of the pre-treatment screening process, which eliminated the "first night effect" which can distort results if participants are not adapted to the monitoring. Subsequent PSG was repeated in the homes at 6 weeks and 6 months, after randomization to 3 groups of which 2 groups took medications (zopiclone or placebo) with a weekly reinforcement meeting. They were given the opportunity to continue the medications after the initial 6 weeks. The third group received 6 weeks of counseling with included sleep hygiene education, sleep restriction, stimulus control, progressive relaxation techniques and brief cognitive therapy (6 individual 50-minute treatment sessions).

Total time awake during the night measured by PSG was significantly less at 6 weeks among the cognitive behavioral therapy (CBT) group vs medications or placebo, declining from 108 to 51 minutes awake (52% improvement compared to 4% for medication and 16% for placebo). The sleep diaries from the participants indicated 34% CBT improvement vs 16% for medication and 21% for placebo. Total sleep time by PSG was not significantly changed for all 3 groups (although their diaries all indicated improvement), but slow wave sleep improved 27% in the CBT group and actually worsened by 20% in the medication group and by 13% in the placebo group.

Six-month follow-up with PSG showed no significant differences from the 6-week findings except more total sleep time in the CBT group, which was also reflected in the diaries.

Commentary

Improvements for chronic insomnia using cognitive behavioral therapy compared to pharmacotherapy have previously been shown in young and middle-aged adults, but not so clearly in older adults.1 Outcomes data have been limited to self-reports, without measurement of stage 3 and 4 slow-wave sleep which is believed responsible for daytime dysfunction attributed to insomnia. This current study uses PSG along with sleep diaries as more objective measurement, and eliminates any doubt that therapy can have good outcomes in older adults as well.

The new non-benzodiazepine medication zopiclone was studied here, which is a precursor to the active stereoisomer eszopiclone available in the United States as Lunesta.™ Funding was provided by non-pharmacologic sources and a head-to-head comparison was done. While their results could be unique to the medication used, it's more likely to be valid since previous studies have shown similar outcomes using other medications. In this study the medication did not show any significant improvement at 6 weeks, and the authors note that most research on sleep medications does not extend beyond 4 weeks in the literature.

For chronic insomnia, it appears that a counseling approach should be used rather than medications, and clinicians can cite these studies to help persuade patients against using nightly medications. Since the placebo results were even better than the drug, one wonders if patients should also be given a choice to take placebo and avoid potential side effects. The unreliability of the sleep diaries compared to PSG suggests that education must be a major component of counseling, both about the mechanics of sleep and patient expectations. As with so many clinical conditions, insomnia results from many interacting influences and requires our time and patience to improve.

Reference

1. Jacobs GD, et al. Cognitive behavior therapy and pharmacotherapy for insomnia. Arch Intern Med. 2004:164;1888-1896.