AASM Releases Guideline on Pharmacologic Treatment for Insomnia

A new clinical practice guideline issued by the American Academy of Sleep Medicine (AASM) aims to improve the pharmacologic treatment of chronic insomnia in adults.

Michael J. Sateia, M.D.

The guideline represents the first comprehensive, evidence-based analysis of medications commonly used to treat people experiencing persistent trouble falling asleep and staying asleep, Michael J. Sateia, M.D., chair of the guideline development task force, told Psychiatric News.

Medications referenced in the guideline include sedative-hypnotics, antidepressants, and other prescription drugs, as well as over-the-counter sleep aids, said Sateia. He is an emeritus professor of psychiatry at Dartmouth’s Geisel School of Medicine, and former chief of sleep medicine at the Dartmouth-Hitchcock Medical Center, Hanover, N.H.

The list includes medications approved by the Food and Drug Administration (FDA) for treating chronic insomnia as well as several agents often used off-label for this disorder. Previous meta-analyses of pharmacologic treatments for insomnia, Sateia noted, focused only on broad classes of drugs.

The guideline, published in the Journal of Clinical Sleep Medicine in February, does not recommend one medication for insomnia over another. The task force found there were too few comparative efficacy studies to support such choices. Instead, the guideline offers recommendations on whether clinicians should or should not use specific medications for sleep-onset insomnia and/or sleep maintenance insomnia in adults versus no treatment, based on current published evidence (see box below).

Medications, including over-the-counter sleep aids, are the most widely used treatments for insomnia after treatment of co-existing illnesses and other problems that undermine sleep. The other major treatment modality, cognitive-behavioral therapy for insomnia (CBT-I), remains the standard of care. The guideline recommends that clinicians offer CBT-I as the primary intervention for all patients with chronic insomnia, an estimated 5 to 10 percent of adults in the United States and other industrialized nations.

Although hypnotic medications and CBT-I appear to be comparably efficacious in acute treatment, there is evidence to suggest that patients who have concluded treatment are more likely to maintain gains achieved with CBT-I than those resulting from medication alone.

The guideline recommends clinicians consider prescribing medications to patients with chronic insomnia who cannot participate in CBT-I, whose symptoms persist despite trying CBT-I, or who need a temporary adjunct to CBT-I.

According to a study using National Health and Nutrition Examination Survey (NHANES) data from 1999 to 2010, just under 3 percent of the sample population of American adults had taken a commonly used medication for insomnia in the past month. Benzodiazepine receptor agonist hypnotics, predominantly zolpidem, were the most commonly prescribed (1.23 percent of the population), followed by trazodone (0.97 percent). Many agents often used to improve sleep, including melatonin and other over-the-counter products, Sateia said, were not included in the NHANES study data. Other survey findings suggest that about 1 in 4 adults uses a medication to aid sleep.

According to the guideline, most meta-analyses of pharmacotherapy for insomnia suggest small-to-moderate effect sizes for most major sleep outcome variables with both benzodiazepine receptor agonists (BZDs) and newer BZD receptor agonistic modulators (BzRAs).

Such studies typically address relatively short-term use of medications for sleep, ranging from one day to about five weeks. Recent controlled trials, Sateia said, have found BzRAs improved sleep in people with chronic insomnia for six months, without producing tolerance or dependence, and continued to provide such benefits in open-label extensions for up to 24 months.

There is little evidence to support the use of sedating antidepressants, such as trazodone, to treat chronic insomnia, he said. Nonetheless, he continued, these medications may be appropriate for people with psychiatric comorbidities, and only a clinician can decide which treatment is right for each patient.

To produce the guideline, AASM commissioned a task force composed of four sleep specialists, all psychiatrists, plus an AASM staff member. The task force conducted a systematic review to identify randomized, controlled trials of drug therapy for chronic insomnia identified through PubMed and published by January 2016. The group used a state-of-the-art methodology known as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process to assess the strength of evidence in reported clinical data.

Current standards for assessing efficacy of medications for sleep include analysis of sleep outcome variables, such as reducing time taken to fall asleep or time spent awake after sleep onset. Quality of sleep or daytime function, Sateia noted, may be equally or more important in evaluating clinical improvement.

In developing their recommendations, task force members considered the quality of evidence, balance of benefits and harms, and patient values and preferences. The AASM approved the final recommendations, all of which pertain only to adults and include only FDA-approved medications and doses.

Along with Sateia, task force members include Daniel Buysse, M.D., a professor of psychiatry at the University of Pittsburgh School of Medicine; Andrew D. Krystal, M.D., a professor of psychiatry at the University of California, San Francisco; David N. Neubauer, M.D., a professor of psychiatry at the Johns Hopkins University School of Medicine; and Jonathan Heald, AASM’s director of science and research. ■