Sleep: Is It Overrated?
Sleep: Is It Overrated?
Abstract & Commentary
By Barbara A. Phillips, MD, MSPH, Professor of Medicine, University of Kentucky; Director, Sleep Disorders Center, Samaritan Hospital, Lexington. Dr. Phillips is a retained consultant for Cephalon and Ventus, and serves on the speakers bureau for Cephalon and Boehringer Ingelheim.
Synopsis: For patients with chronic insomnia, sleeping pills in combination with cognitive behavioral therapy (CBT) resulted in improved sleep satisfaction during acute therapy, but long-term treatment was enhanced by stopping the medication and continuing only CBT.
Source: Morin CM, Vallières A, Guay B, et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: A randomized controlled trial. JAMA 2009;301:2005-2015.
This study is a prospective evaluation of cognitive behavioral therapy (CBT) with a hypnotic (zolpidem, 10 mg) in 160 patients with chronic insomnia. For this study, chronic insomnia was defined as: 1) difficulties initiating and/or maintaining sleep, defined as a sleep onset latency and/or wake after sleep onset greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least three nights per week (as measured by daily sleep diaries); 2) insomnia duration longer than six months; and 3) significant distress or impairment of daytime functioning (rating of 2 on item 5 of the Insomnia Severity Index [ISI]). In an effort to eliminate those with lifestyles or underlying medical or mental illnesses that are known to be associated with sleep complaints, there were many exclusion criteria, and potential subjects underwent a history and physical examination, sleep testing examination, and screening for psychiatric illness. Indeed, two-thirds of those screened for the study had to be excluded for one of these reasons.
Participants were initially randomized to CBT alone or combined therapy of CBT plus 10 mg of zolpidem nightly. After the first six weeks ("acute treatment"), they were again randomized (and split into four groups) for the next six months ("maintenance treatment"). The patients who were treated with CBT alone during the acute treatment phase were randomized to either CBT alone for six months or to no additional treatment. The patients who were treated with CBT plus zolpidem during the acute phase were randomized to CBT plus zolpidem to be used on an as-needed basis or to CBT alone with no additional zolpidem.
CBT was delivered as weekly 90-minute group sessions during the six-week acute treatment phase, then monthly individual sessions during the six-month maintenance phase. CBT during the acute phase included recommendations to restrict time in bed to the actual time slept and gradually increase it back as sleep improved. In addition, patients were instructed to go to bed only when sleepy at night; to use the bed and bedroom only for sleep and sex; to get out of bed and go in another room whenever they were unable to fall asleep or return to sleep within 20 minutes and return to bed only when sleepy again; and to get up at the same time every morning. Patients were also instructed in the elements of sleep hygiene. Cognitive behavioral therapy aimed to address unrealistic sleep expectations and amplification of the consequences of insomnia. CBT during the maintenance phase was individualized; techniques of relaxation, worry management, and problem solving were used as needed. CBT was administered by master's level clinical psychologists who used a treatment manual.
The subjects assigned to receive zolpidem received 10 mg/night of zolpidem, which they were instructed to take 30 minutes before bedtime. The medication was provided weekly during brief visits with a primary care physician. These sessions focused on reviewing sleep diaries and insomnia symptoms during the previous week, as well as monitoring potential adverse effects. During the maintenance phase, those assigned to receive zolpidem prn met with the physician monthly and received 10 zolpidem pills per month with the instruction to take a pill only when it was needed. At the end of the six-month extended CBT phase, zolpidem was tapered according to a written withdrawal schedule (decrease the dose from 10 mg to 5 mg during the first week and then take 5 mg every other night until they ran out).
Assessments were conducted at baseline, at the end of the initial six-week phase, at the end of the six-month extended treatment phase, and six months after all treatment ended. Measurements used during assessments included sleep diaries and sleep studies at baseline, two weeks after the acute treatment, and at the end of the six months of maintenance treatment. Subjects also completed the ISI, a seven-item subjective inventory of sleep complaints and satisfaction at intervals during the study.
The participants were all white, and included 97 women and 63 men, whose mean age was 50.3 years. Most were in a relationship (68.1%) and employed (73.3%). Most (73.8%) had both sleep-onset and maintenance insomnia, and the mean insomnia duration was 16.4 years. A total of 63 patients had previously used a sleep medication (but discontinued it prior to the study). About 15% of the sample had a comorbid psychiatric disorder (most commonly an anxiety disorder) and more than half had at least one comorbid medical disorder, which was most commonly a cardiovascular condition. About 7% dropped out after the first six weeks, about 12% dropped out after the six-month maintenance phase, and about 20% dropped out during the final six months of follow-up. Thus, nearly 40% of the sample was lost by the end of the study.
Attendance at CBT sessions was good, with an average of more than 5.5 (out of 6) sessions attended in each of the CBT arms during the acute phase, and about 5.5 (out of 6) sessions during the six-month maintenance phase. Use of the sleeping pills decreased over time; 90.9% of pills were taken during the first week and 79.1% were taken during the sixth week. During the six-month maintenance phase, patients in the CBT plus zolpidem prn group took about half of the 10 available zolpidem pills each month.
After the six-week acute treatment phase, self-reported sleep-onset latency for the CBT group was about 20 minutes shorter, and for the CBT plus zolpidem group about 12 minutes shorter than at baseline. For self-reported time awake after sleep onset (WASO), there was a mean reduction of 68 minutes for the CBT group, and 83 minutes for the CBT plus zolpidem group. For sleep efficiency (the estimated fraction of time spent in bed actually sleeping), the participants who received CBT alone reported an average increase of about 14%, and the CBT plus zolpidem group reported an average increase of about 16%. Tests for interactions showed that the CBT plus zolpidem group experienced about 16 minutes greater increase of total sleep time compared with patients treated with CBT alone during the six-week acute treatment phase. During objective measurement by sleep study (polysomnography) for which the results of two successive nights of testing were averaged, the changes were not as robust as reported in the sleep diaries; for CBT and CBT plus zolpidem, respectively, sleep-onset latency fell by about six and three minutes, WASO fell by about 27 minutes in both groups, and sleep efficiency increased about 5% in both groups. Interestingly, however, objectively measured sleep time fell 26 and 19 minutes. For the objectively measured data, although the changes appeared small, they were all statistically significant after the acute phase of treatment.
After the six months of maintenance therapy, there were no further changes in self-reported sleep latency for any of the four groups (CBT alone for the entire treatment; CBT for six weeks then no further treatment; CBT + zolpidem acutely, then CBT + prn zolpidem; CBT + zolpidem acutely, then CBT alone). For self-reported WASO, there were small increases (not good) for all four groups, but the increase was statistically significant only for the CBT plus prn zolpidem group. The only group that did not have a statistically significant increase in self-reported total sleep time after the six months of maintenance therapy was the CBT + prn zolpidem group. There were no changes in any group for self-reported sleep efficiency. For the objectively measured sleep study data, the primary changes were reduced sleep efficiency and increased WASO for the groups that received zolpidem at any point.
At the end of the subsequent six months of follow-up with no further active treatment, there were no further changes in self-reported sleep, except for self-reported total sleep time, which increased another 21 minutes for the CBT alone group. Objective testing showed an increase of about five minutes in total sleep latency for the group that received CBT acutely then no additional treatment. There was worsening in sleep efficiency (a reduction of about 4%) in the group that got CBT plus prn zolpidem, and an increase in sleep-onset latency in the CBT alone with no additional treatment group compared with the CBT plus extended treatment group.
Insomnia severity scales indicated similar decreases in insomnia severity for both groups in the acute phase, with no additional change observed for the rest of the study.
Response and remission (defined by ISI score) rates were calculated. Response occurred in about 60% of the CBT alone and 62% of the CBT + zolpidem group. Remission was highest for the CBT alone groups over the course of the study (56% compared with about 43% after the six-month maintenance period), and increased over the course of the subsequent follow-up with no active treatment, up to about 68%, compared to about 42% for the groups that received zolpidem.
What does this mean? Well, the authors (while noting that this was probably not a representative sample of insomniacs, being white and mostly healthy) stated that these findings "suggest that combining medication with CBT may provide an added benefit during the initial course of therapy, but the clinical significance of such added benefit is unclear." The authors also point out that these findings demonstrate that CBT is effective treatment for insomnia, which we should have already known.1 This study comes on the heels of an observational study by the same group,2 in which a three-year follow-up of insomniacs showed that about two-thirds of those who met diagnostic criteria for insomnia at time zero still reported problems three years later.2,3 In this study of somewhat shorter duration, the groups who received CBT (plus or minus zolpidem) had remission rates of about 68%. So maybe CBT (with a sleeping pill in the acute treatment phase) can make a difference in the long run.
The take home message here is that insomnia is often chronic and difficult to treat. The backbone of treatment of insomnia really ought to be CBT. This is particularly true in view of recent reports that chronic use of hypnotics is associated with death4-6 and with an increased risk of car crash.7
It is hard to get patients to CBT for a lot of reasons, including that such practitioners are rare, insurance often does not cover it, it is time-consuming, and some patients resist behavioral treatment, preferring instead to have a "medical" diagnosis. But many are increasingly convinced it is the way to go. And many patients with insomnia really do not want to take sleeping pills, as evidenced by the poor adherence to zolpidem in this study. Patients can visit the National Sleep Foundation web site (www.sleepfoundation.org) for information about sleep in general, including sleep hygiene and CBT specifically.8 If third-party payers balk, a short note and a copy of the NIH report might help.
1. National Institutes of Health. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. Sleep 2005; 28:1049-1057.
2. Morin CM, Bélanger L, LeBlanc M, et al. The natural history of insomnia: A population-based 3-year longitudinal study. Arch Intern Med 2009;169:447-453.
3. Wilke AJ. Will I ever get a good night's sleep? Intern Med Alert 2009;31:77-78.
4. Mallon L, Broman JE, Hetta J. Is usage of hypnotics associated with mortality? Sleep Med 2009;10:279-286.
5. Kripke DF, Simons RN, Garfinkel L, et al. Short and long sleep and sleeping pills. Is increased mortality associated? Arch Gen Psychiatry 1979;36:103-116.
6. Hublin C, Partinen M, Koskenvuo M, et al. Sleep and mortality: A population-based 22-year follow-up study. Sleep 2007;30:1245-1253.
7. Gustavsen I, Bramness JG, Skurtveit S, et al. Road traffic accident risk related to prescriptions of the hypnotics zopiclone, zolpidem, flunitrazepam and nitrazepam. Sleep Med 2008;9:818-822.
8. National Sleep Foundation. Available at: www.sleepfoundation.org/site/c.huIXKjM0IxF/b.2421175/k.431/Cognitive_Behavioral_Therapy_for_Insomnia.htm.For patients with chronic insomnia, sleeping pills in combination with cognitive behavioral therapy (CBT) resulted in improved sleep satisfaction during acute therapy, but long-term treatment was enhanced by stopping the medication and continuing only CBT.
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