Chapter 83 Treatment Guidelines for Insomnia

Abstract

Treatment guidelines are evidence and consensus-based recommendations that are intended to guide clinical practice. Guidelines are particularly important in areas where multiple efficacious treatments exist but data regarding comparative efficacy may be sparse. Previous chapters have described the substantial body of evidence regarding the efficacy and safety of behavioral and pharmacologic treatments for chronic insomnia. However, despite these data, clinicians continue to use a number of less rigorously evaluated medications for the treatment of insomnia. Moreover, relatively few data are available to describe the comparative efficacy of different treatments, or the process by which a clinician should choose one treatment versus another. This chapter reviews general principles regarding the use of treatment guidelines in clinical medicine and the recommendations from the American Academy of Sleep Medicine’s clinical guideline for the evaluation and management chronic insomnia in adults. The guideline emphasizes a thorough initial evaluation of patients with chronic insomnia; first-stage treatment with either behavioral treatment or a benzodiazepine receptor agonist medication; repeated evaluations of efficacy and side effects; and changes in therapy for nonresponse. Future research will guide refinements of this initial guideline.

The Role of Clinical Practice Guidelines

Clinical medicine is often characterized by uncertainties regarding diagnosis, selection of appropriate treatment, and measurement of outcomes for individual patients. The boundaries of one diagnosis versus another, even against no diagnosis at all, can be difficult to ascertain. In the field of insomnia, for instance, distinguishing a person with chronic sleep-onset insomnia from someone with delayed sleep phase disorder can be quite challenging. Likewise, multiple efficacious treatments are often available for a particular condition. This is certainly true for insomnia, with multiple behavioral and pharmacologic treatments demonstrating short-term and long-term efficacy data. What is considerably more challenging is trying to determine which treatment is best suited for which particular patient based on that patient’s preferences, the characteristics of their disorder, and the availability of treatments. Having instituted a treatment, it can also be challenging to determine when a patient has derived sufficient benefit to continue a treatment, or whether discontinuing treatment or switching to an alternate modality may be indicated.

Clinical practice guidelines are designed to assist the clinician with such challenges. The Institute of Medicine (IOM) defined practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.”¹^,² Practice guidelines can be classified into a number of categories, such as assessment of therapeutic effectiveness, counseling, diagnosis, evaluation, management, prevention, rehabilitation, risk assessment, screening, technology assessment, and treatment.³

In its original report, the IOM distinguished practice guidelines from related concepts including medical review criteria, standards of quality, and performance measures. The distinctions among these concepts are summarized in Box 83-1. In addition to defining practice guidelines, the IOM also identified eight attributes of good practice guidelines. These include validity, reliability or reproducibility, clinical applicability, clinical flexibility, clarity, multidisciplinary process, scheduled review, and documentation. This outline has been widely adopted in many areas of clinical medicine, including sleep medicine.

Box 83-1

Adapted from Institute of Medicine. Clinical practice guidelines: directions for a new program. Washington, DC: National Academy Press; 1990.

Definitions of Practice Guidelines and Related Constructs

Practice Guidelines

Systematically developed statements to assist practitioner and patient in forming decisions about appropriate health care for specific clinical circumstances.

Medical Review Criteria

Systematically developed statements that can be used to assess the appropriateness of specific health care decisions, services, and outcomes.

Standards of Quality

Authoritative statements of minimum levels of acceptable performance or results, excellent levels of performance or results, or the range of acceptable performance or results.

Performance Measures

Methods or instruments to estimate or monitor the extent to which the actions of a health care practitioner or provider conform to practice guidelines, medical review criteria, or standards of quality.

The National Guideline Clearinghouse (NGC) (www.guideline.gov) is a website supported by the Agency for Healthcare Research and Quality (AHRQ). As of January 2009, the National Guideline Clearinghouse listed more than 2400 practice guidelines from 48 recognized clinical specialties, including sleep medicine. The NGC archives, summarizes, and classifies guidelines. It also provides a number of tools including a glossary, links to related websites, and specific tools for submitting guidelines. The NGC uses a standard summary format for clinical guidelines, including categories such as methodology, recommendations, evidence supporting the recommendations, identifying information of the sponsoring organizations and authors, and availability.

At the center of all clinical practice guidelines is some type of systematic review, which refers to a summary of the clinical literature providing a critical assessment and evaluation of all research studies that address a particular clinical issue.⁴ Systematic reviews often, but not always, include quantitative analyses of data, such as meta-analyses. In addition, practice guidelines must use some specific method for formulating recommendations. These may range from informal expert consensus, to more standardized methods such as the Delphi method, nominal group technique, or a consensus development conference.³ In applying guidelines and other methods of evidence-based medicine, it is also important to recognize that many factors beyond data from clinical trials influence clinical decision making. For example, the patient’s preferences, characteristics, and ability to implement a treatment; the clinician’s expertise; the availability of a treatment; and cost are all important considerations. As stated succinctly by Haynes and colleagues, “Evidence does not make decisions, people do.”⁵

The American Academy of Sleep Medicine (AASM) provides two types of documents to guide clinical decision making. The first are standards of practice parameters, which provide physicians with clear recommendations for evaluating and managing patients with sleep disorders based on current scientific evidence in the medical literature.⁶ Practice parameters follow the AHRQ and NGC guidelines, and are based on exhaustive reviews of the scientific literature conducted by a task force of experts. These practice parameters undergo internal and external peer review before publication and are reviewed and updated every 3 to 5 years.

The second type of guideline provided by the AASM is clinical guidelines, which are designed to provide comprehensive recommendations for evaluation, diagnosis, treatment, and follow-up for patients with sleep disorders. Clinical guidelines are designed for areas in which a lower degree of evidence may be present or in which greater individual decision making is required. Clinical guidelines incorporate the AASM’s evidence-based practice parameters and supplement them with consensus-based recommendations from a task force of experts. Clinical guidelines include methods for diagnosis, treatment options, and recommended long-term management strategies. To date, the AASM has issued two clinical guidelines, both published in the Journal of Clinical Sleep Medicine.⁷^,⁸

In 2008, the AASM released its Clinical Practice Guideline for evaluating and managing chronic insomnia in adults.⁷ The strengths and limitations of the available evidence make this topic a very appropriate one for clinical guidelines. Strengths of the current available data include a large number of efficacy trials regarding both behavioral and pharmacologic treatments for insomnia. However, many limitations also exist.

There is considerably less evidence for actual effectiveness of these trials, namely, efficacy in usual care settings. Although some case series have been reported for behavioral treatment of insomnia,⁹ systematic effectiveness trials are not yet available. There is also fairly limited evidence regarding the direct comparative efficacy of different modalities of treatment, including direct comparisons of behavioral and pharmacologic treatments (see Chapter 79).

There is very little systematic evidence regarding the matching of specific patient characteristics with specific treatments in order to achieve optimal outcomes. Although pharmacologic treatment efficacy trials often select patients with certain characteristics, such as sleep-onset insomnia, this is not equivalent to determining differential efficacy among subgroups of patients. Likewise, there are small studies suggesting superiority of one form of behavioral or psychological treatment versus another, but no large-scale studies have been conducted.

There is very little evidence regarding true long-term outcomes of insomnia treatments. Some behavioral treatment studies have examined follow-up intervals of up to 2 years,¹⁰^,¹¹ and some purely retrospective observational studies have examined pharmacologic treatment outcomes over approximately 10 years.¹² However, these do not amount to systematic examinations of long-term effectiveness in actual patient populations.

Thus, the treatment of insomnia presents a combination of areas with substantial evidence, and areas of relatively little evidence, making it well-suited to the development of a clinical practice guideline.

Development of Insomnia Clinical Guidelines

Recognizing the need for systematic guidelines in evaluating and managing insomnia, and aware of the paucity of sound evidence in many related areas, the AASM appointed a task force of content experts to develop a uniform set of recommendations for the comprehensive assessment and treatment of patients with chronic insomnia. The task force was instructed to derive evidence-based recommendations from existing practice parameters, where such parameters existed, and to develop consensus-based guidelines in the absence of these standards. The guidelines were to be based in the diagnostic classification system for insomnia of the International Classification of Sleep Disorders, second edition (ICSD-2).

The consensus process began with a systematic literature review for the period 1999 to 2006 (supplementing and updating reviews of previous practice parameters). The resulting literature was reviewed for relevance and sorted by task force members, who were assigned specific areas of focus. A modified nominal group process technique was used in developing consensus. Members generated comprehensive lists of potential diagnostic and therapeutic strategies that were subsequently ranked by all task force members. Based on these rankings and subsequent discussion, specific guidelines were developed. Areas in which previous evidence-based parameters existed were not altered.

The guidelines are identified as evidence-based (with level of recommendation)¹³ or consensus-based. Throughout the rest of the chapter, the type of recommendation—Consensus, Guideline, or Standard—is indicated in parentheses. The guidelines were reviewed by outside content experts and members of the AASM board of directors.

The AASM guidelines provide recommendations for a comprehensive approach to the assessment and treatment of patients with chronic insomnia. As such, they do not address management issues for acute insomnia, nor are they directly relevant to managing insomnia in children.

Evaluation

The evaluation section of the guidelines is based on previously published evidence-based standards of practice ¹⁴^,¹⁵ and consensus of the task force. Figure 83-1 summarizes the guideline recommendations. The central tenet of this section is that “insomnia is primarily diagnosed by clinical evaluation through a thorough sleep history and detailed medical, substance, and psychiatric history” (standard). This evaluation process can be organized into three major areas: characterization of the insomnia complaint and the consequences thereof; comprehensive assessment of sleep–wake schedule, behavior, and related symptoms; and medical and psychiatric history and examination. These inquiries may be supported by a number of questionnaires and instruments that provide additional information regarding the insomnia condition, other sleep-related symptoms (e.g., sleepiness), psychological state, daytime function, and quality of life.