Clinical Evaluation of Interventions for the Management of Insomnia: A Review of Reviews.

Abstract

Background Insomnia is a common disorder in the general Canadian population. While precise estimates vary, approximately 40% of Canadian adults (18 years of age and older) report at least one symptom of insomnia three times per week and about 10% to 13% meet criteria for an insomnia disorder.1,2 Persistent insomnia has a negative impact on the individual and society, as it is linked to reduced quality of life (QoL) due to problems with attention and memory, mood disturbances, lower ratings of enjoyment of interpersonal relationships, and more days unable to work or carry out normal daily activities than those without insomnia.3 Furthermore, studies have indicated that insomnia may be an important risk factor for the onset of mental health disorders such as depression, anxiety, and substance abuse disorders. Both pharmacological and non-pharmacological approaches are used in the management of insomnia, either alone, or in combination. Health Canada–approved pharmacological therapies for insomnia include benzodiazepine drugs (e.g., temazepam, lorazepam), nonbenzodiazepine receptor agonists, also referred to as “z-drugs” (e.g., zopiclone, zolpidem), and doxepin, a sedating antidepressant drug. Several drugs belonging to various classes (anxiolytic benzodiazepine drugs, antipsychotic drugs, antidepressant drugs) are also prescribed for insomnia despite having no approved indication for insomnia.4 The safety of pharmacological therapies for the treatment of insomnia — especially risks associated with long-term use — has been an increasing area of uncertainty. Moreover, benzodiazepine drugs and z-drugs alone have been associated with substantial costs for payers (public and private), regardless of the indication.5 Cognitive behavioural therapy (CBT) is the most common non-pharmacological intervention used in the management of insomnia; it is a multimodal intervention that combines behavioural and cognitive techniques and can be delivered in different formats including individual, group, or self-directed therapy. However, unlike medication, psychological therapy such as CBT is not widely available, is expensive for many individuals due to lack of insurance coverage, and may have long wait times for treatment.5 Objective and Research Questions This report is a review of available evidence regarding the clinical effectiveness and safety of pharmacological and non-pharmacological interventions for the treatment of insomnia in adults. This report is part of a larger CADTH Health Technology Assessment (HTA) project that aims to inform policy and practice questions related to the treatment of insomnia in adults through an assessment of the clinical effectiveness and safety of available treatment (the current report); a summary of patients’ and caregivers’ perspectives and experiences; and an assessment of current practices and trends in drug and non-drug therapies for adult patients with insomnia disorder. The research questions for this review were: 1. What are the effectiveness and comparative effectiveness of treatments for insomnia disorder in adults? 2. What is the long-term safety of interventions for insomnia disorder in adults? Methods A review of systematic reviews (SRs) that were conducted to assess the clinical effectiveness, comparative clinical effectiveness, and/or safety of interventions for the treatment of insomnia disorder in adults was carried out. The review of SRs approach was chosen as there are a number of SRs that exist on this topic (see Section 4 — Results of Clinical Evaluation). Leveraging this work through a review of existing SRs, rather than carrying out a de novo SR, was the most reasonable approach to reviewing this topic as this would avoid having to invest substantial resources and time with no obvious benefits. Published literature was identified by searching bibliographic databases (MEDLINE, Embase, PsycINFO, the Cochrane Library, and PubMed) and ‘grey literature’ (noncommercially published sources) identified using the Grey Matters checklist. A filter was applied to limit database searches to SRs and meta-analyses (MAs); when possible animal studies were removed; and no restrictions on language or date of publication were applied. Searches were supplemented through searching the bibliographies of included reviews and other key papers. Inclusion criteria for the review were established using the population, intervention, comparison, and outcome (PICO) framework.6,7 Eligible populations were adults (18 years of age and older) with a diagnosis of acute (less than three months) or chronic (greater than three months) insomnia based on diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., (DSM-IV), the International Classification of Sleep Disorders (ICSD), or the Research Diagnostic Criteria (RDC) for insomnia.8 Subgroups of interest (based on input from CADTH jurisdictional stakehol...