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Controversies in the treatment of primary insomnia
Sleep Medicine 1 (2000) 259±261
www.elsevier.com/locate/sleep
Editorial
Controversies in the treatment of primary insomnia Consensus building in establishing standardized protocols for the treatment of primary insomnia has been a slow process. In part, this results from our limited understanding of the causes and consequences of primary insomnia. Some broad guidelines have emerged: consensus statements have been published that recommend sedative-hypnotic medication is best suited to treatment of transient insomnia, or should be used only on a short-term basis in patients with chronic insomnia. The role of sedative-hypnotics in the treatment of insomnia still generates controversy since, in practice, patients with chronic insomnia are still treated pharmacologically. Cognitive-behavioral therapy (CBT) is increasingly recommended as the treatment of choice for patients with primary insomnia, and as adjunctive treatment in other types of insomnia that are chronic in duration. Pharmacological treatment or CBT used alone has established treatment ef®cacy, but the use of a combined treatment approach is controversial: is ef®cacy and long-term outcome improved with combined use of cognitive-behavioral treatment and hypnotic medication in the treatment of patients with primary insomnia, as compared to either treatment alone?
1. Rationale for combining treatment modalities McCluskey et al. [1] compared the ef®cacy of triazolam to behavioral treatment (BT: relaxation training and stimulus control therapy) in the treatment of primary insomnia. Patients receiving triazolam showed immediate improvement, while the BT group only improved after 2 weeks of treatment. However, the triazolam group showed relapse at the
follow-up assessment (5 weeks after the end of treatment), while the BT group maintained their improvement. The authors suggested that combining treatments would provide the advantage of immediate relief from poor sleep (medication effect), but also provide long-term bene®t (BT effect). Clinically, this is an appealing approach since patients with insomnia are often highly anxious about their poor sleep and this anxiety may contribute further to sleep disturbance. At times the distress of patients with insomnia is extreme, and it is dif®cult to convince them to engage in a treatment approach that will not yield bene®t until after 2 weeks (or longer). Symptomatic treatment with hypnotic medication may provide suf®cient relief that the patient is better able to engage in the behavior changes that are required to allow bene®t from CBT approaches. Further support for attempting to combine the strengths of both treatment approaches is found in the literature on treatment of depression and anxiety disorders. Recent outcome studies of the treatment of depression show clearly that patients receiving a treatment combination of psychotherapy (cognitive-behavioral analysis, up to 20 sessions) and medication (nefazodone, up to 600 mg/day) have a better response than those patients who receive just one of these treatments [2]. Similar results have also been recently reported for a combination of CBT and pharmacotherapy in the treatment of panic disorder [3].
2. Empirical data Several intervention studies have been conducted to assess the ef®cacy of combined vs. single treatment approaches for insomnia. Milby et al. [4]
1389-9457/00/$ - see front matter q 2000 Elsevier Science B.V. All rights reserved. PII: S 1389-945 7(00)00051-4
260
E. Stepanski, J.K. Wyatt / Sleep Medicine 1 (2000) 259±261
compared triazolam with BT (relaxation training and stimulus control) to triazolam with sleep-related information. This latter group was a control condition designed to act as a medication-only group, but with a component of sleep education to control for the effects of attention and therapist contact as provided in the BT condition. Both groups showed improved sleep during the treatment phase, but only the BT group maintained these gains at the follow-up assessment. These data seemed to support the combination of treatment approaches, but had the limitation of administering medication to both treatment groups. Hauri [5] evaluated the effect of combining treatments by comparing sleep hygiene/relaxation training alone (RT) and sleep hygiene/relaxation training with triazolam 0.25 mg to a wait-list control group. Both treatment groups demonstrated improved sleep after treatment compared to the control group. However, 10 months after treatment, the RT group still maintained signi®cantly improved sleep while the combined group did not. This is the ®rst study to compare a combined treatment group to a behavioral treatment only group, and these results offer a different view of the implications of combining treatment. The combined treatment appears to be advantageous compared to pharmacological treatment alone [4], but has a worse long-term outcome when compared to behavioral treatment alone [5]. A more de®nitive study would compare medication alone, BT alone, combined treatment, and a credible placebo control group in the same protocol. This study design was employed by Morin et al. [6] in their comprehensive intervention study. The medication used was temazepam 7.5±30 mg, and the behavioral treatment used was a CBT program that included sleep restriction therapy, stimulus control therapy, as well as cognitive restructuring. The combined treatment group had the best sleep at the post-treatment assessment, but the CBT alone group had the best sleep at the long-term follow-up assessment (2 years after the end of treatment). One limitation of the Morin et al. [6] study is that the placebo condition did not control for amount of therapist contact and other non-speci®c effects that could occur with the CBT program. It could be argued that this condition provided a control for the pharmacological treatment, but not the CBT condition. This
problem is addressed in a new study by Rosen et al. [7]. This study has three treatment conditions: medication with muscle relaxation, medication with guided imagery, and medication with sleep education (the control condition). For complete results, see Rosen et al. [7]. The results of these studies [1,4±7] show a consistent pattern. Combined treatment is as or more ef®cacious than single treatments in the short-term, and is better than medication alone in the long-term. However, it is not as good as behavioral treatment alone in the long-term. These results suggest that patients taking medication may not learn behavioral techniques as effectively as those not taking medication. Patients may rely on the medication to improve their sleep, and never develop the same con®dence in their own ability to control their sleep through relaxation techniques or other behavioral changes. The lack of superiority of the combined treatment condition is in contrast to the pattern of results seen in the treatment of depression. This difference may re¯ect a difference in the mechanism of action of the pharmacological treatment. Antidepressant medication is presumed to correct an underlying etiology, (i.e. chemical imbalance) of depression, and may work synergistically with psychotherapy that provides increased coping and decreases cognitive-behavioral etiologies of depression. In comparison, hypnotic medication is only providing symptomatic treatment rather than addressing a primary etiology of the disorder. Hypnotic medication may provide more than symptomatic improvement for certain patients, (e.g. those with physiological hyperarousal as a cause of insomnia), and it is possible that combined treatments would be more helpful in those cases. A better understanding of the etiology of primary insomnia is needed to investigate this possibility.
References [1] McCluskey H, Milby J, Switzer P, Williams V, et al. Ef®cacy of behavioral versus triazolam treatment in persistent sleep-onset insomnia. Am J Psychiatry 1991;148:121±126. [2] Keller M, McCullough J, Klein D, Arnow B, et al. A comparison of nefazodone, the cognitive-behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. NEJM 2000;342:1462±1470. [3] Barlow D, Gorman J, Shear M, Woods S. Cognitive-behavioral
E. Stepanski, J.K. Wyatt / Sleep Medicine 1 (2000) 259±261
[4] [5] [6] [7]
therapy, imipramine, or their combination for panic disorder. A randomized controlled trial. JAMA 2000;283:2529±2536. Milby J, Williams V, Hall J, Khuder S, et al. Effectiveness of combined triazolam-behavioral therapy for primary insomnia. Am J Psychiatry 1993;150:1259±1260. Hauri P. Can we mix behavioral therapy with hypnotics when treating insomniacs? Sleep 1997;20:1111±1118. Morin C, Colecchi C, Stone J, Sood R, et al. Behavioral and pharmacological therapies for late-life insomnia. A randomized controlled trial. JAMA 1999;281:991±999. Rosen RC, Lewin DS, Goldberg L, Woolfolk RL. Psychophysiological insomnia: combined effects of pharmacotherapy and relaxation-based treatments. Sleep Med 2000;1:279±288.
261
Edward Stepanski*, James K. Wyatt Sleep Disorders Service and Research Center, RushPresbyterian-St. Luke's Medical Center, 1653 West Congress Parkway, Chicago, IL 60612-3833, USA * Corresponding author. Tel.: 11-312-942-5440; fax: 11-312942-8961. E-mail address: [email protected] (E. Stepanski)
www.elsevier.com/locate/sleep
Editorial
Controversies in the treatment of primary insomnia Consensus building in establishing standardized protocols for the treatment of primary insomnia has been a slow process. In part, this results from our limited understanding of the causes and consequences of primary insomnia. Some broad guidelines have emerged: consensus statements have been published that recommend sedative-hypnotic medication is best suited to treatment of transient insomnia, or should be used only on a short-term basis in patients with chronic insomnia. The role of sedative-hypnotics in the treatment of insomnia still generates controversy since, in practice, patients with chronic insomnia are still treated pharmacologically. Cognitive-behavioral therapy (CBT) is increasingly recommended as the treatment of choice for patients with primary insomnia, and as adjunctive treatment in other types of insomnia that are chronic in duration. Pharmacological treatment or CBT used alone has established treatment ef®cacy, but the use of a combined treatment approach is controversial: is ef®cacy and long-term outcome improved with combined use of cognitive-behavioral treatment and hypnotic medication in the treatment of patients with primary insomnia, as compared to either treatment alone?
1. Rationale for combining treatment modalities McCluskey et al. [1] compared the ef®cacy of triazolam to behavioral treatment (BT: relaxation training and stimulus control therapy) in the treatment of primary insomnia. Patients receiving triazolam showed immediate improvement, while the BT group only improved after 2 weeks of treatment. However, the triazolam group showed relapse at the
follow-up assessment (5 weeks after the end of treatment), while the BT group maintained their improvement. The authors suggested that combining treatments would provide the advantage of immediate relief from poor sleep (medication effect), but also provide long-term bene®t (BT effect). Clinically, this is an appealing approach since patients with insomnia are often highly anxious about their poor sleep and this anxiety may contribute further to sleep disturbance. At times the distress of patients with insomnia is extreme, and it is dif®cult to convince them to engage in a treatment approach that will not yield bene®t until after 2 weeks (or longer). Symptomatic treatment with hypnotic medication may provide suf®cient relief that the patient is better able to engage in the behavior changes that are required to allow bene®t from CBT approaches. Further support for attempting to combine the strengths of both treatment approaches is found in the literature on treatment of depression and anxiety disorders. Recent outcome studies of the treatment of depression show clearly that patients receiving a treatment combination of psychotherapy (cognitive-behavioral analysis, up to 20 sessions) and medication (nefazodone, up to 600 mg/day) have a better response than those patients who receive just one of these treatments [2]. Similar results have also been recently reported for a combination of CBT and pharmacotherapy in the treatment of panic disorder [3].
2. Empirical data Several intervention studies have been conducted to assess the ef®cacy of combined vs. single treatment approaches for insomnia. Milby et al. [4]
1389-9457/00/$ - see front matter q 2000 Elsevier Science B.V. All rights reserved. PII: S 1389-945 7(00)00051-4
260
E. Stepanski, J.K. Wyatt / Sleep Medicine 1 (2000) 259±261
compared triazolam with BT (relaxation training and stimulus control) to triazolam with sleep-related information. This latter group was a control condition designed to act as a medication-only group, but with a component of sleep education to control for the effects of attention and therapist contact as provided in the BT condition. Both groups showed improved sleep during the treatment phase, but only the BT group maintained these gains at the follow-up assessment. These data seemed to support the combination of treatment approaches, but had the limitation of administering medication to both treatment groups. Hauri [5] evaluated the effect of combining treatments by comparing sleep hygiene/relaxation training alone (RT) and sleep hygiene/relaxation training with triazolam 0.25 mg to a wait-list control group. Both treatment groups demonstrated improved sleep after treatment compared to the control group. However, 10 months after treatment, the RT group still maintained signi®cantly improved sleep while the combined group did not. This is the ®rst study to compare a combined treatment group to a behavioral treatment only group, and these results offer a different view of the implications of combining treatment. The combined treatment appears to be advantageous compared to pharmacological treatment alone [4], but has a worse long-term outcome when compared to behavioral treatment alone [5]. A more de®nitive study would compare medication alone, BT alone, combined treatment, and a credible placebo control group in the same protocol. This study design was employed by Morin et al. [6] in their comprehensive intervention study. The medication used was temazepam 7.5±30 mg, and the behavioral treatment used was a CBT program that included sleep restriction therapy, stimulus control therapy, as well as cognitive restructuring. The combined treatment group had the best sleep at the post-treatment assessment, but the CBT alone group had the best sleep at the long-term follow-up assessment (2 years after the end of treatment). One limitation of the Morin et al. [6] study is that the placebo condition did not control for amount of therapist contact and other non-speci®c effects that could occur with the CBT program. It could be argued that this condition provided a control for the pharmacological treatment, but not the CBT condition. This
problem is addressed in a new study by Rosen et al. [7]. This study has three treatment conditions: medication with muscle relaxation, medication with guided imagery, and medication with sleep education (the control condition). For complete results, see Rosen et al. [7]. The results of these studies [1,4±7] show a consistent pattern. Combined treatment is as or more ef®cacious than single treatments in the short-term, and is better than medication alone in the long-term. However, it is not as good as behavioral treatment alone in the long-term. These results suggest that patients taking medication may not learn behavioral techniques as effectively as those not taking medication. Patients may rely on the medication to improve their sleep, and never develop the same con®dence in their own ability to control their sleep through relaxation techniques or other behavioral changes. The lack of superiority of the combined treatment condition is in contrast to the pattern of results seen in the treatment of depression. This difference may re¯ect a difference in the mechanism of action of the pharmacological treatment. Antidepressant medication is presumed to correct an underlying etiology, (i.e. chemical imbalance) of depression, and may work synergistically with psychotherapy that provides increased coping and decreases cognitive-behavioral etiologies of depression. In comparison, hypnotic medication is only providing symptomatic treatment rather than addressing a primary etiology of the disorder. Hypnotic medication may provide more than symptomatic improvement for certain patients, (e.g. those with physiological hyperarousal as a cause of insomnia), and it is possible that combined treatments would be more helpful in those cases. A better understanding of the etiology of primary insomnia is needed to investigate this possibility.
References [1] McCluskey H, Milby J, Switzer P, Williams V, et al. Ef®cacy of behavioral versus triazolam treatment in persistent sleep-onset insomnia. Am J Psychiatry 1991;148:121±126. [2] Keller M, McCullough J, Klein D, Arnow B, et al. A comparison of nefazodone, the cognitive-behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. NEJM 2000;342:1462±1470. [3] Barlow D, Gorman J, Shear M, Woods S. Cognitive-behavioral
E. Stepanski, J.K. Wyatt / Sleep Medicine 1 (2000) 259±261
[4] [5] [6] [7]
therapy, imipramine, or their combination for panic disorder. A randomized controlled trial. JAMA 2000;283:2529±2536. Milby J, Williams V, Hall J, Khuder S, et al. Effectiveness of combined triazolam-behavioral therapy for primary insomnia. Am J Psychiatry 1993;150:1259±1260. Hauri P. Can we mix behavioral therapy with hypnotics when treating insomniacs? Sleep 1997;20:1111±1118. Morin C, Colecchi C, Stone J, Sood R, et al. Behavioral and pharmacological therapies for late-life insomnia. A randomized controlled trial. JAMA 1999;281:991±999. Rosen RC, Lewin DS, Goldberg L, Woolfolk RL. Psychophysiological insomnia: combined effects of pharmacotherapy and relaxation-based treatments. Sleep Med 2000;1:279±288.
261
Edward Stepanski*, James K. Wyatt Sleep Disorders Service and Research Center, RushPresbyterian-St. Luke's Medical Center, 1653 West Congress Parkway, Chicago, IL 60612-3833, USA * Corresponding author. Tel.: 11-312-942-5440; fax: 11-312942-8961. E-mail address: [email protected] (E. Stepanski)