Patients suffering from chronic insomnia should receive cognitive behavioral therapy (CBT) as a first-line treatment for the condition, the American College of Physicians (ACP) recommends in new clinical practice guidelines published online May 3 in the Annals of Internal Medicine.
"[CBT] for insomnia consists of a combination of treatments that include cognitive therapy around sleep, behavioral interventions (such as sleep restriction and stimulus control), and education (such as sleep hygiene)," write Amir Qaseem, MD, PhD, from the ACP, and colleagues.
Relying on moderate-quality evidence, the ACP strongly recommends that "all adult patients receive [CBT] for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder." If CBT by itself does not effectively treat insomnia, the ACP relied on lower-quality evidence to recommend that providers and patients discuss the benefits, harms, and costs of short-term use of medication and then use a shared decision-making approach to determine whether to add medication to a patient's treatment plan.
CBT-I "typically involves 6 to 8 customized sessions in which patients are encouraged to change sleep and daytime habits, alter nonproductive sleep schedules, and modify beliefs about insomnia," write Roger G. Kathol, MD, from the University of Minnesota in Minneapolis, and J. Todd Arnedt, PhD, from the University of Michigan Medical School in Ann Arbor, in an accompanying editorial. "By engaging patients to be active participants in their sleep health, CBT-I therapists teach cognitive and behavioral skills that resolve or attenuate chronic insomnia in 70% to 80% of treated persons, often without supplemental medication."
Despite the clear evidence base, however, the ACP recommendations have several obstacles to overcome, Dr Kathol and Dr Arnedt write. Those challenges primarily include some clinicians not considering insomnia a health problem, some physicians' biases against psychological/behavioral interventions, and insufficient training among providers to deliver CBT, especially in medical settings.
"The first step in implementing the new ACP guideline is for physicians to recognize that a psychological alternative to pharmacologic therapy will accomplish better and safer patient outcomes," Dr Kathol and Dr Arnedt write. However, patients receiving CBT need ongoing support and instruction, as they must be more actively engaged in their treatment than if they were solely taking medication. "Support and encouragement to continue, despite initial adversity, can be the difference between CBT-I success and failure."
They note with frustration that most patients have insufficient access to CBT because of both insurance reimbursement requirements and too few trained practitioners.
"[I]nadequate access to well-trained CBT-I practitioners contributes to the broader finding that only 1 in 9 patients treated in the general medical sector receives minimally effective behavioral health treatment," they write. Although they mention virtual CBT delivery options, Dr Kathol and Dr Arnedt note that CBT works best in person and often requires face-to-face treatment to qualify for reimbursement.
"A long-term solution requires a team effort by policymakers, physicians, health care administrators, sleep medicine specialists, and CBT-I therapists," Dr Kathol and Dr Arnedt write.
In writing the recommendations, Dr Qaseem and colleagues relied on two evidence reviews also published online May 3 in the Annals of Internal Medicine. A systematic review by Timothy J. Wilt, MD, MPH, from the Minneapolis Veterans Affairs Health Care System in Minnesota, and colleagues analyzes data from 35 randomized controlled trials and 11 long-term observational trials on pharmacologic treatments for insomnia, all published from 2004 to 2015. This review also includes data from product labels and a US Food and Drug Administration review for nonbenzodiazepine hypnotics and orexin receptor antagonists. A second evidence report, by Michelle Brasure, PhD, MSPH, MLIS, from the Division of Health Policy and Management, School of Public Health, University of Minnesota, Minneapolis, and colleagues, focuses on assessing the benefits and harms of psychological and behavioral interventions to treat insomnia and includes a review of 60 randomized controlled trials.
In the pharmacology systematic review, eszopiclone, zolpidem, and suvorexant all moderately improved short-term sleep outcomes compared with placebo, but insufficient evidence existed to suggest that benzodiazepine hypnotics, melatonin agonists, antidepressants, or other medications helped.
"Benefits of pharmacologic treatment include improved sleep outcomes, such as sleep onset latency and total sleep time, and in some cases improved global outcomes in the general population and in older adults," Dr Qaseem and colleagues write.
"There was insufficient evidence overall on the comparative effectiveness and safety of the various pharmacologic treatments."
Data from the US Food and Drug Administration and observational studies suggest the risks from hypnotics or other pharmacological treatments for insomnia include dementia, fractures, major injury, driving impairment, and cognitive and behavioral changes.
The systematic review on behavioral interventions for insomnia found CBT most beneficial among various behavioral interventions, leading to "improved remission, treatment response, sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality in the general population," Dr Qaseem and colleagues write. The review also showed a low risk for harm from CBT or other behavioral therapies.
Too little data existed to compare behavioral therapy with medication for treatment of insomnia or to assess the safety or efficacy of complementary and alternative treatments such as acupuncture and Chinese herbal medicine.
The Agency for Healthcare Research and Quality funded the research reviews that provided the evidence for the recommendations, but the recommendations were funded solely by the ACP. Dr Kathol and Dr Arnedt have disclosed no relevant financial relationships. One member of the Clinical Guidelines Committee of the ACP has received personal fees from a wide range of speaking, lecturing, consulting, and expert witness services to medical institutions, providers, professional societies, insurers, and attorneys. His spouse holds stock in Pfizer and Johnson & Johnson, which yields them dividends. Another member has received grants, fees and nonfinancial support from the Informed Medical Decisions Foundation and Healthwise. Two members were recused from voting on the recommendations despite their involvement in the discussions because they had an active indirect conflict. The other authors and members have disclosed no relevant financial relationships.
Ann Intern Med. Published online May 3, 2016.