June 27, 2006 -- Cognitive behavioral therapy (CBT) is better than zopiclone for the treatment of chronic insomnia, according to the results of a randomized, double-blinded study reported in the June 28 issue of JAMA."Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences," write B�rge Sivertsen, PsyD, from the University of Bergen in Norway, and colleagues. "Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking.... No studies have compared the newer nonbenzodiazepine sleep medications with nonpharmacological treatments and, to our knowledge, no studies have examined whether CBT affects slow-wave sleep (stages 3 and 4) in treating insomnia."Between January 2004 and December 2005 at a single Norwegian, university-based outpatient clinic, 46 adults with chronic primary insomnia were randomized to treatment with CBT (n = 18), 7.5-mg zopiclone each night (n = 16), or placebo medication (n = 12). Mean age was 60.8 years, and 22 participants were women. CBT consisted of sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation. Each treatment lasted for 6 weeks, and both active treatments were followed up at 6 months. Primary endpoints were total wake time, total sleep time, sleep efficiency, and slow-wave sleep, measured with ambulant clinical polysomnographic data and sleep diaries.On 3 of 4 outcome measures, CBT was associated with improved short- and long-term outcomes compared with zopiclone. For most outcomes, zopiclone was no different than placebo. At 6-month follow-up, participants receiving CBT improved their sleep efficiency from 81.4% at pretreatment to 90.1%, whereas sleep efficiency in the zopiclone group decreased from 82.3% to 81.9%. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) than did those in other groups, and they spent less time awake during the night. Although total sleep time was similar in all 3 groups, at 6 months, patients receiving CBT had better sleep efficiency on polysomnography than did those taking zopiclone."These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults," the authors write.Study limitations include lack of generalizability to patients whose sleep problems are secondary to psychiatric or medical conditions or to primary care settings; average sleep quality relatively high at pretreatment assessment; lack of follow-up beyond 6 months after treatment completion; and relatively small group sizes; lack of blinding or placebo control for the CBT condition; lack of data specifically addressing daytime sleepiness; and inability to generalize the present findings with zopiclone to other sleep medications."Regardless of these limitations, the present findings have important implications for the clinical management of chronic primary insomnia in older adults," the authors conclude. "Given the increasing amount of evidence of the lasting clinical effects of CBT and lack of evidence of long-term efficacy of hypnotics, clinicians should consider prescribing hypnotics only for acute insomnia. At present, CBT-based interventions for insomnia are not widely available in clinical practice, and future research should focus on implementing low-threshold treatment options for insomnia in primary care settings." The University of Bergen, the Meltzer Fund, and the EXTRA funds from the Norwegian Foundation for Health and Rehabilitation funded this study. The authors have disclosed no relevant financial disclosures.JAMA. 2006;295:2851-2858
Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
- Compare the short-term effect of CBT vs zopiclone and placebo on sleep in older adult patients with chronic primary insomnia.
- Compare the long-term effect of CBT vs zopiclone on sleep in patients with chronic primary insomnia.
According to the authors, insomnia, defined as subjective complaints of poor sleep accompanied by daytime impairment in function, affects 9% to 25% of those older than 55 years, and prevalence increases with age, with reduced quality of life and increased healthcare utilization. Up to 85% of those affected are untreated, and two thirds report poor knowledge of treatment options. Among primary care clinicians, medications have been the first choice of treatment, according to the current authors, although long-term use of medications is associated with risk for habituation and dependency. CBT is the most widely used psychological intervention for insomnia and may be superior to medication in the long term.
The current study is a randomized controlled trial conducted at one center to compare the short-term (6 weeks) and long-term (6 months) effect of CBT vs zopiclone and placebo on sleep in patients older than 55 years with chronic primary insomnia.
- Inclusion criteria were 55 years or older, meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for insomnia, insomnia duration of at least 3 months, and complaints of daytime impairment in functioning.
- Exclusion criteria were use of hypnotic medication within 4 weeks, dementia or other cognitive dysfunction, Mini Mental Status Examination score of less than 23, major psychiatric disorder, sleep apnea, working night shifts, or serious somatic condition.
- Participants were screened by telephone interview and 2 consecutive nights of ambulant polysomnography (PSG) and then randomized to the 3 treatments.
- Of 45 participants (22 women, 24 men), 18 were assigned to CBT, 16 received 7.5 mg of zopiclone daily, and 12 received placebo for 6 weeks. Assignment to zopiclone and placebo was double blinded.
- CBT comprised 6 individual weekly sessions, each lasting 50 minutes facilitated by 2 clinical psychologists based on a manualized approach that included sleep hygiene education, sleep restriction, stimulus control, cognitive therapy, and progressive relaxation.
- Outcome measures included total sleep time, total wake time, sleep efficiency, and slow-wave sleep measured by both PSG and sleep diaries.
- Clinical PSG, which included electroencephalography, electromyography, and electro-oculography were recorded at 3 assessment points: baseline, 6 weeks, and 6 months.
- Participants completed sleep diaries every morning for 2 weeks at the 3 assessment points.
- Mean age was 61 years, mean duration of insomnia was 14 years, mean years of education was 14 years, and 33% consumed more than 2 cups of coffee daily.
- Adherence was 100% in the CBT group, and overall adherence across all 3 groups was high.
- At 6 weeks, the CBT group showed significantly improved total wake time by PSG vs the other 2 groups with total wake time reduced by 52% vs 4% in the zopiclone and 16% in the placebo group.
- Total sleep time was not significantly different among the 3 groups by PSG.
- Sleep efficiency by PSG was significantly improved in the CBT vs the other 2 groups (P = .004).
- The amount of PSG-recorded slow-wave sleep (stages 3 and 4) improved significantly over time in the CBT compared with the placebo (P = .03) and the zopiclone (P = .002) groups.
- Sleep diary records showed improvement over time for total wake time, total sleep time, and sleep efficiency in all 3 groups, but there were no significant differences between groups.
- At 6-month follow-up, only the CBT and zopiclone groups were compared.
- Total sleep time by PSG increased significantly for the CBT group vs baseline (P = .05). In the zopiclone group, there was no improvement from baseline.
- Total wake time, sleep efficiency, and slow-wave sleep by PSG were all significantly better in the CBT vs the zopiclone group.
- Total sleep time by PSG was not significantly different between the 2 groups.
- Using the sleep diary, the CBT group showed increase in total sleep time at 6 months vs 6 weeks and total wake time declined in the CBT group vs the zopiclone group (P = .03).
- The proportion of participants who reached a PSG-recorded sleep efficiency level of at least 85% was higher in the CBT group at 6 weeks and 6 months than in the zopiclone group.
- In the CBT group, this proportion was 33% at baseline, 72% at 6 weeks, and 78% at 6 months.
- In the zopiclone group, this proportion was 40% at baseline, 47% at 6 weeks, and 40% at 6 months.
Pearls for Practice
- Six weeks of CBT compared with 7.5 mg of zopiclone daily or placebo in patients with chronic primary insomnia is associated with better total wake time, sleep efficiency, and slow-wave sleep by PSG but not total sleep time at 6 weeks.
At 6 months, the effect of 6 weeks of CBT compared with 7.5 mg of zopiclone is better for PSG-recorded total wake time, sleep efficiency, total sleep time, and slow-wave sleep.