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Treatment of Older Adults with Insomnia, Agitation, Or Delirium with Benzodiazepines: a Review of the Clinical Effectiveness and Guidelines

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Treatment of Older Adults with Insomnia, Agitation, Or Delirium with Benzodiazepines: a Review of the Clinical Effectiveness and Guidelines TITLE: Treatment of Older Adults with Insomnia, Agitation, or Delirium with Benzodiazepines: A Review of the Clinical Effectiveness and Guidelines DATE: 14 January 2016 CONTEXT AND POLICY ISSUES Insomnia is a common sleep complaint, with up to 40% of older adults reporting difficulty getting to sleep, early awakening, or feeling unrefreshed upon waking.1 Risk factors for insomnia include medical and psychiatric disorders, psychological factors, stress, daytime napping, hyperarousal, and advancing age.1 Management of insomnia includes treatment for any medical or psychiatric illness that may be contributing to insomnia, behavioral therapy (e.g., sleep hygiene, relaxation, or cognitive therapy), and/or medication. Available medications used to treat insomnia include benzodiazepines, non-benzodiazepine sedatives (e.g. zopiclone, zolpidem), melatonin agonists, and antidepressants (e.g. doxepin).2 Benzodiazepines may also be used to manage patients with delirium and agitation.3 Older adults, however, may be at increased risk of adverse events from sedative drugs. In particular, those with reduced renal or hepatic function may experience excessive sedation due to reduced drug elimination and drug accumulation.2 The objective of this report is to evaluate the clinical efficacy and safety, and guidelines for use of sedative hypnotic agents in older adults with insomnia, agitation or delirium. This report is an update to a previous Rapid Response Summary of Abstracts on the treatment of older adults with insomnia, agitation or delirium with benzodiazepines.4 RESEARCH QUESTIONS 1. What is the clinical effectiveness of the treatment of older adults with insomnia, agitation, or delirium with benzodiazepines or other sedative hypnotic agents? 2. What are the evidence-based guidelines for the treatment of older adults with insomnia, agitation, or delirium with benzodiazepines or other sedative hypnotic agents? Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. KEY FINDINGS In older adults, low dose doxepin (up to 6 mg daily) appears to be more effective than placebo for the short-term treatment of insomnia. The short-term incidence of adverse effects with doxepin and placebo appears to be similar; however no conclusions can be drawn due to limitations in the evidence available. No studies or evidence-based guidelines were identified on the use of benzodiazepines or other sedative hypnotics in older adults. METHODS Literature Search Methods This report makes use of a literature search conducted for a previous CADTH report.4 The original literature search was conducted in March 2015 on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, Canadian and major international health technology agencies, as well as a focused Internet search. Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, and guidelines. Where possible, retrieval was limited to the human population. The initial search was also limited to English-language documents published between January 1, 2010 and March 30, 2015. For the current report, database searches were rerun on December 4, 2015 to capture any articles published since the initial search date. The search of major health technology agencies was also updated to include documents published since March 2015. Rapid Response reports are organized so that the evidence for each research question is presented separately. Selection Criteria and Methods One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Older adults with insomnia, agitation, or delirium Subgroup: end stage kidney disease patients who have chosen conservative management (i.e., no dialysis or transplant) Intervention Benzodiazepines Other sedative hypnotics Comparator Other treatments No benzodiazepines or other sedatives Outcomes Clinical effectiveness (benefits and harms [e.g. fractures, falls, deaths, hospitalizations]) Guidelines and recommendations Study Designs Systematic reviews, health technology assessments, meta-analyses, randomized controlled trials (RCTs), guidelines Treatment of Older Adults with Insomnia, Agitation, or Delirium with Benzodiazepines 2 Exclusion Criteria Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, were published prior to 2010, or examined drugs that have not been approved for use in Canada. Systematic reviews and clinical guidelines were excluded if they did not meet accepted standards for methodological rigor. Critical Appraisal of Individual Studies The included systematic review was critically appraised using the Assessment of Multiple Systematic Reviews (AMSTAR) checklist.5 Summary scores were not calculated; rather, a review of the strengths and limitations of the study was described. SUMMARY OF EVIDENCE Quantity of Research Available A total of 22 citations were identified in the update to the literature search. Following screening of titles and abstracts, 20 citations were excluded and two potentially relevant reports from the electronic search were retrieved for full-text review. Eight potentially relevant publications were retrieved from the previous Summary of Abstracts report. No relevant articles were identified in the updated grey literature search. Of these potentially relevant articles, nine publications were excluded for various reasons, while one systematic review met the inclusion criteria and was included in this report.6 Appendix 1 describes the PRISMA flowchart of the study selection. None of the studies included in the previous Rapid Response Report met the inclusion criteria when the full text reports were examined. One systematic review and three RCTs were for drugs that have not been approved for use in Canada (ramelteon, eszopiclone and EVT-201).7- 10 These studies have been listed in the Appendix 5. One guideline did not include the interventions of interest for the treatment of delirium.11 Two other systematic reviews and one guideline were excluded due to methodological limitations.1,12,13 The key limitations of the systematic reviews included no duplicate selection of articles or extraction of data,1,12 no quality assessment of individual studies,1,12 and inappropriate methods to analyze and summarize data.12 For the guideline, only a summary was available, and from this it was unclear if the recommendations were based on a systematic review of the literature, and if the internal and external review process was robust.13 Summary of Study Characteristics A summary of the characteristics of the included systematic review is presented in Appendix 2. Study Design The systematic review (Yeung 20156) included nine double-blind RCTs, however this report will focus on the three RCTs that enrolled older patients. These three trials were industry sponsored studies published between 2008 and 2012. Two trials used a parallel design and one was a cross-over study. Yeung et al,6 summarized the studies narratively due to differences in study design and doxepin dosage. Treatment of Older Adults with Insomnia, Agitation, or Delirium with Benzodiazepines 3 Country of Origin The systematic review was conducted in Hong Kong.6 Patient Population The three trials in older adults restricted enrollment to patients greater or equal to 65 years of age. The mean age per study ranged from 71.0 to
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