Most adults experience problems with sleep from time to time, and 6%-10% meet diagnostic criteria for chronic insomnia. Many of these patients present to their primary care clinicians looking for help. This clinical practice guideline from the American College of Physicians provides recommendations based on a review of studies published during the previous decade, which were assessed in terms of the strength of the recommendation and the quality of evidence. The guideline resulted in two recommendations:
1: All adult patients should receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia. (strong recommendation)
2: Clinicians should use a shared decision-making approach discussing the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (weak recommendation)
Cognitive behavioral therapy for insomnia (CBT-I)
Cognitive behavioral therapy for insomnia encompasses a variety of measures that aim to change patients’ habits and beliefs associated with sleep. These measures include general “sleep hygiene” interventions, as well as stimulus control, sleep restriction, relaxation training, and cognitive reframing. With sleep hygiene, patients are educated about environmental factors that affect sleep, such as avoiding caffeine late in the day, limiting alcohol intake, having a regular sleep schedule, avoiding napping, the importance of exercise, and the importance of a quiet dark room in which to sleep. Examples of stimulus control include going to bed only when sleepy, and avoiding reading and watching TV in the bedroom. Sleep restriction limits the time in bed with strict sleep and wake-up times, gradually increasing time in bed as sleep efficiency improves.
Clinicians may find it surprising that this guideline makes such a strong, clear case for the primacy of behavioral measures in the treatment of chronic insomnia. The authors make a number of points in support of this position.
First, the effects of behavioral interventions appear to be robust – at least comparable to the short-term effects of medications – and often significantly better. For example, various studies of CBT-I show a decrease in sleep onset latency (how long it takes to fall asleep after going to bed) of between 12 and 31 minutes and an increase in total sleep time of 40 minutes. This compares favorably to the short-term effects of commonly used sleep medications.
Second, the effects of behavioral interventions are long-lasting compared with medications, which are usually approved for only short-term use, lose effectiveness over time, and have no benefit at all once they’re no longer being taken. Finally, there appear to be no harms associated with CBT-I, compared with significant adverse effects of medications.
One challenge is that access to effective behavioral interventions for insomnia can be an issue. On the other hand, a number of behavioral delivery methods were examined, and found to be effective, including in-person individual or group therapy, telephone- or Web-based modules or apps, and self-help books. An editorial accompanying the guidelines calls for efforts to increase the availability of behavioral modalities for insomnia.
Pharmacologic therapy
The recommendation to use pharmacologic therapy for insomnia is much more qualified than that for CBT-I, with language about shared decision-making, discussion of risks and benefits, emphasis on short-term use, and a provision that it be used only after an unsatisfactory trial of CBT-I alone. In addition, this recommendation is classified as “weak,” and the associated evidence “low-quality.” Medications reviewed included eszopiclone, zaleplon, zolpidem, orexin receptor antagonist, melatonin, ramelteon, and benzodiazepines.
There are several reasons why pharmacologic therapy is deemphasized. First, as noted above, the effects of commonly used medications are modest. As an example, typical patients with chronic insomnia will have sleep-onset latency of 60-70 minutes. Medications reviewed for this guideline decreased this time by approximately 10-20 minutes in short-term studies, so patients still took 40-60 minutes to fall asleep. Similar modest short-term effects were seen in terms of increasing total sleep time.
A second issue with pharmacologic therapy is that while many patients with chronic insomnia seek to use medications long term, the available studies have tended to look only at short-term use, and those studies with longer duration show a diminution of medication effect over time.
Finally, there are significant adverse effects associated with sedative-hypnotic medications, including somnolence, anxiety, confusion, and disturbance in attention. This is problematic, considering that these are precisely the symptoms that patients may be hoping to avoid when they take medications to help them sleep. Even patients who may not feel impaired often show demonstrable deficits in attention and performance following use of sleep medications; this issue is reflected in the boxed warnings that accompany several commonly prescribed agents.
It is noted in the evidence reviews that there are differences among the available medications. The nonbenzodiazepine hypnotics eszopiclone and zolpidem as well as the orexin receptor antagonist suvorexant improved short-term sleep quality, though the effect was small and there was significant evidence of harm as described above. Benzodiazepine hypnotics, melatonin agonists, and antidepressants studied had little or low-quality evidence to support efficacy on improving sleep. For melatonin and ramelteon, the evidence review notes that adverse effects did not differ between the medication and the placebo groups, though two open-label longer-term studies showed evidence of adverse effects with ramelteon. It is also important to note that patients studied in medication trials were mostly healthy middle-aged individuals; it is possible that the side effects of sleep medications may be greater in those who are older or more infirm.
Bottom line
This guideline from the American College of Physicians strongly endorses the use of tailored cognitive behavioral therapy modalities for the initial treatment of patients with chronic insomnia. Medications are given a weak recommendation for a limited back-up role.
Dr. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.
References
Qaseem A, et al. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165:125-33.
Brasure M. Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:113-24.
Wilt TJ, et al. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:103-12.
