Bernard Guay

Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial.

CONTEXT Cognitive behavioral therapy (CBT) and hypnotic medications are efficacious for short-term treatment of insomnia, but few patients achieve complete remission with any single treatment. It is unclear whether combined or maintenance therapies would enhance outcome. OBJECTIVES To evaluate the added value of medication over CBT alone for acute treatment of insomnia and the effects of maintenance therapies on long-term outcome. DESIGN, SETTING, AND PATIENTS Prospective, randomized controlled trial involving 2-stage therapy for 160 adults with persistent insomnia treated at a university hospital sleep center in Canada between January 2002 and April 2005. INTERVENTIONS Participants received CBT alone or CBT plus 10 mg/d (taken at bedtime) of zolpidem for an initial 6-week therapy, followed by extended 6-month therapy. Patients initially treated with CBT attended monthly maintenance CBT for 6 months or received no additional treatment and those initially treated with combined therapy (CBT plus 10 mg/d of zolpidem) continued with CBT plus intermittent use of zolpidem or CBT only. MAIN OUTCOME MEASURES Sleep onset latency, time awake after sleep onset, total sleep time, and sleep efficiency derived from daily diaries (primary outcomes); treatment response and remission rates derived from the Insomnia Severity Index (secondary outcomes). RESULTS Cognitive behavioral therapy used singly or in combination with zolpidem produced significant improvements in sleep latency, time awake after sleep onset, and sleep efficiency during initial therapy (all P<.001); a larger increase of sleep time was obtained with the combined approach (P = .04). Both CBT alone and CBT plus zolpidem produced similar rates of treatment responders (60% [45/75] vs 61% [45/74], respectively; P = .84) and treatment remissions (39% [29/75] vs 44% [33/74], respectively; P = .52) with the 6-week acute treatment, but combined therapy produced a higher remission rate compared with CBT alone during the 6-month extended therapy phase and the 6-month follow-up period (56% [43/74 and 32/59] vs 43% [34/75 and 28/68]; P = .05). The best long-term outcome was obtained with patients treated with combined therapy initially, followed by CBT alone, as evidenced by higher remission rates at the 6-month follow-up compared with patients who continued to take zolpidem during extended therapy (68% [20/30] vs 42% [12/29]; P = .04). CONCLUSION In patients with persistent insomnia, the addition of medication to CBT produced added benefits during acute therapy, but long-term outcome was optimized when medication is discontinued during maintenance CBT. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00042146.

Hypnotic Taper with or without Self-Help Treatment of Insomnia: A Randomized Clinical Trial.

This study aimed to assess the efficacy of a minimal intervention focusing on hypnotic discontinuation and cognitive-behavioral treatment (CBT) for insomnia. Fifty-three adult chronic users of hypnotics were randomly assigned to an 8-week hypnotic taper program, used alone or combined with a self-help CBT. Weekly hypnotic use decreased in both conditions, from a nearly nightly use at baseline to less than once a week at posttreatment. Nightly dosage (in lorazepam equivalent) decreased from 1.67 mg to 0.12 mg. Participants who received CBT improved their sleep efficiency by 8%, whereas those who did not remained stable. Total wake time decreased by 52 min among CBT participants and increased by 13 min among those receiving the taper schedule alone. Total sleep time remained stable throughout withdrawal in both CBT and taper conditions. The present findings suggest that a systematic withdrawal schedule might be sufficient in helping chronic users stop their hypnotic medication. The addition of a self-help treatment focusing on insomnia, a readily available and cost-effective alternative to individual psychotherapy, produced greater sleep improvement.

Comparison of subjective and objective sleep quality in menopausal and non-menopausal women with insomnia

BACKGROUND Insomnia affects midlife women as they approach and experience menopause at a rate higher than most other stages of life. Insomnia is considered one of the climacteric symptoms of menopause, which can be controlled with hormone replacement therapy (HRT). This study examined the relationship between menopause and sleep in women with insomnia and compared the sleep quality of menopausal women with and without HRT. METHODS A total of 74 women (age range=40-59 years old) with insomnia who were either pre or peri/post menopause were evaluated at Laval Universitys Sleep Disorders Center as part of ongoing clinical trials of insomnia therapies. All participants completed daily sleep diaries for a 2-week period and a series of psychological and insomnia questionnaires, followed by three consecutive nights of polysomnographic evaluation (PSG). A detailed medical history interview was taken by the study physician. RESULTS PSG measures showed that menopausal women had significantly longer total wake time (TWT, 84.2 vs. 63.2 min, Cohens d=0.504) and lower sleep efficiency (SE, 81.8% vs. 86.0%, d=0.487) than the non-menopausal women. Women using HRT did not show significantly better sleep compared to those who did not use HRT. No significant difference was observed between menopausal groups on subjectively assessed sleep parameters. CONCLUSION Menopause may contribute to specific aspects of sleep disturbances in midlife women with insomnia. Use of HRT for menopausal symptoms does not seem to attenuate such disturbances, although further investigation using hormonal level dosing and a larger sample size is warranted.

Speed and trajectory of changes of insomnia symptoms during acute treatment with cognitive–behavioral therapy, singly and combined with medication

OBJECTIVES To examine the speed and trajectory of changes in sleep/wake parameters during short-term treatment of insomnia with cognitive-behavioral therapy (CBT) alone versus CBT combined with medication; and to explore the relationship between early treatment response and post-treatment recovery status. METHODS Participants were 160 adults with insomnia (mean age, 50.3 years; 97 women, 63 men) who underwent a six-week course of CBT, singly or combined with 10 mg zolpidem nightly. The main dependent variables were sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and sleep quality, derived from sleep diaries completed daily by patients throughout the course of treatment. RESULTS Participants treated with CBT plus medication exhibited faster sleep improvements as evidenced by the first week of treatment compared to those receiving CBT alone. Optimal sleep improvement was reached on average after only one week for the combined treatment compared to two to three weeks for CBT alone. Early treatment response did not reliably predict post-treatment recovery status. CONCLUSIONS Adding medication to CBT produces faster sleep improvement than CBT alone. However, the magnitude of early treatment response is not predictive of final response after the six-week therapy. Additional research is needed to examine mechanisms involved in this early treatment augmentation effect and its impact on long-term outcome.

Sequential Treatment for Chronic Insomnia: A Pilot Study

This article explores the efficacy of sequential treatment involving medication and cognitive behavioral treatment (CBT) for insomnia. In a multiple baseline across-subjects design, 6 participants with primary chronic insomnia received 1 of the following treatment sequences: (a) concurrent combination of medication and CBT for the 10-week treatment duration (Combined); (b) medication for the first 5 weeks, with introduction of CBT at week 4 and medication withdrawal after the 5th week resulting in treatment overlap during weeks 4 and 5 (Overlapping: Medication → Combined → CBT); and (c) medication alone for the first 5 weeks followed by CBT alone for an additional 5 weeks (Medication → CBT). Each sequence led to significant sleep improvements, but these improvements occurred at different times during the intervention. Participants in the Combined and in the Overlapping sequences improved their sleep during the 1st phase of treatment, whereas those in the Medication → CBT sequence improved mostly during the 2nd phase of treatment. These preliminary results suggest that a sequential treatment is effective for chronic insomnia. In addition, the results suggest that sleep improvements are more likely to emerge when CBT is introduced, with an Overlapping sequence showing a slight advantage over the other sequences. Additional clinical trials should be conducted with larger samples to replicate these preliminary findings.

Long-Term Maintenance of Therapeutic Gains Associated With Cognitive-Behavioral Therapy for Insomnia Delivered Alone or Combined With Zolpidem

Study objectives To document the long-term sleep outcomes at 12 and 24 months after patients with chronic insomnia were treated with cognitive-behavioral therapy (CBT), either singly or combined with zolpidem medication. Methods Participants were 160 adults with chronic insomnia. They were first randomized for a six-week acute treatment phase involving CBT alone or CBT combined with nightly zolpidem, and randomized for a six-month extended treatment phase involving CBT, no additional treatment, CBT combined with zolpidem as needed, or CBT with zolpidem tapered. This paper reports results of the 12- and 24-month follow-ups on the main outcome measures derived from the Insomnia Severity Index and sleep diaries. Results Clinical improvements achieved 6 months following the end of treatment were well-maintained in all four conditions, with insomnia remission rates ranging from 48% to 74% at the 12-month follow-up, and from 44% to 63% at the 24-month follow-up. Participants receiving CBT with zolpidem taper in the extended treatment phase had significantly better results than those receiving CBT with continued zolpidem as needed. The magnitude of improvements on sleep diary parameters was similar between conditions, with a slight advantage for the CBT with zolpidem taper condition. The addition of extended CBT did not alter the long-term outcome over improvements obtained during the initial 6-week CBT. Conclusions The results suggest that CBT for insomnia, when delivered alone or in combination with medication, produce durable sleep improvements up to two years after completion of treatment. These long-term results indicate that even if a combined CBT plus medication approach provide an added benefit immediately after treatment, extending CBT while tapering medication produce better sustained improvements compared to continued use of medication as needed.

Cognitive-behavior therapy singly and combined with medication for persistent insomnia: Impact on psychological and daytime functioning

While impairment of daytime functioning due to poor sleep is often the main determinant for seeking treatment, few studies have examined the clinical impact of insomnia therapies on daytime outcomes. The main objective of this study was to evaluate the impact of cognitive-behavior therapy (CBT), alone and combined with medication, on various indices of daytime and psychological functioning. Participants were 160 individuals with chronic insomnia who received CBT alone or CBT plus medication (zolpidem) for an initial six-week therapy, followed by an extended six-month therapy. Participants treated with CBT initially received maintenance CBT or no additional treatment and those treated with combined therapy initially continued with CBT plus intermittent medication (prn) or CBT without medication (taper). Measures of anxiety and depressive symptoms, fatigue, quality of life, and perceived impact of sleep difficulties on various indices of daytime functioning were completed at baseline, after each treatment stage, and at six-month follow-up. Following acute treatment, significant improvements of fatigue, quality of life (mental component), anxiety, and depression were obtained in the CBT alone condition but not in the combined CBT plus medication condition. Following extended treatment, further improvements were noted for the subgroup receiving extended CBT relative to that with no additional treatment, and for the subgroup receiving CBT and intermittent medication relative to that with CBT but no medication. Improvements were well maintained at the 6-month follow-up. These findings indicate that insomnia-specific therapy is effective at improving daytime and psychological functioning in the short term, and that maintenance therapy produces an added value to optimize long-term outcomes. TRIAL REGISTRATION www.clinicaltrials.gov (#NCT 00042146).