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High Dose and Watchful Dosing of Benzodiazepines: a Review of the Safety and Guidelines

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High Dose and Watchful Dosing of Benzodiazepines: a Review of the Safety and Guidelines TITLE: High Dose and Watchful Dosing of Benzodiazepines: A Review of the Safety and Guidelines DATE: 21 November 2012 CONTEXT AND POLICY ISSUES Benzodiazepines are compounds that enhance the activity of gamma-aminobutyric acid (GABA)-A receptors by increasing the affinity of the receptors for GABA.2 Therefore, benzodiazepines are prescribed as anxiolytic medications. In Canada, the labeled indications include, the treatment of anxiety disorders, panic disorder, insomnia, seizure disorders, skeletal muscle spasticity, and alcohol withdrawal (Table 1).3 The relative safety and effectiveness of the benzodiazepines led to their widespread use.5 Two benzodiazepines, clonazepam and diazepam, are classified by the World Health Organization as "essential drugs" that should be available in all countries for medical purposes.6 However, the use of benzodiazepines have also been associated with several adverse effects, including ataxia, dizziness, over-sedation, anterograde amnesia, and dependence.7 The current review will evaluate the evidence regarding benzodiazepine dosing and the evidence supporting benzodiazepine watchful doses. Watchful doses are doses above which additional assessment and patient monitoring are required. Table 1. Summary of the Available Benzodiazepines in Canada Diazepam Maximum Indicated Drug Equivalent Oral Health Canada Indication Dose (mg)* Dose (mg)** Long-acting Chlordiazepoxide 40 20-50 Anxiety disorders Anxiety, panic, seizure disorders, and alcohol Clorazepate 60 15 withdrawal Anxiety disorders, perioperative medication, Diazepam 40 10 seizure, skeletal muscle spasticity, and alcohol withdrawal Flurazepam 30 30 Insomnia Intermediate-acting Alprazolam 10 1 Anxiety and panic disorder Bromazepam 60 6-12 Anxiety disorders 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 and a summary 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. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. 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. Table 1. Summary of the Available Benzodiazepines in Canada Diazepam Maximum Indicated Drug Equivalent Oral Health Canada Indication Dose (mg)* Dose (mg)** Clobazam 80 20 Seizure disorders Clonazepam 20 0.5-2 Seizure disorders Perioperative medication, anxiety and seizure Lorazepam 4 1-2 disorders Nitrazepam 10 10-20 Insomnia, seizure disorders Oxazepam 120 30 Anxiety disorders, alcohol withdrawal Temazepam 30 20-30 Insomnia Short-acting Midazolam† 0.1 mg/kg Not applicable Perioperative medication Triazolam 0.5 0.5 Insomnia * Information was obtained from Health Canada approved product monograph for each drug3 ** Equivalent doses are approximate and were retrieved from the Canadian National Opioid Use Guideline.10 † Parenteral use only RESEARCH QUESTIONS 1. What is the clinical evidence for safety of high-dose (>10 mg diazepam equivalent) benzodiazepine use? 2. What is the clinical evidence regarding the safety of different watchful doses of benzodiazepines? 3. What are the evidence-based guidelines regarding watchful dosing or high-dose of benzodiazepine? KEY FINDINGS The available evidence suggests that benzodiazepines can be used, under specific circumstances, in higher doses than 10 mg diazepam equivalent without major safety concerns. However, the available information does not support specific values for benzodiazepine watchful doses. METHODS Literature Search Strategy A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2012, Issue 10), University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2007 and October 24, 2012. Selection Criteria and Methods One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed for relevance. Full texts of any relevant titles/abstracts were retrieved Watchful Dosing of Benzodiazepines 2 and assessed. The final article selection was based on the inclusion criteria presented in Table 2. Table 2: Selection Criteria Population Adults or adolescents receiving benzodiazepines Intervention Benzodiazepine (> 10mg diazepam equivalent) Comparator Other benzodiazepine doses or usual care Outcomes Safety, reduction in high dose prescribing, addiction, misuse/abuse, and clinical practice guidelines Study Designs Health technology assessment, systematic review, meta-analysis, randomized controlled trials, and non-randomized studies Exclusion Criteria Studies were excluded if they did not meet the selection criteria. Duplicate reports of the same outcomes from the same trials were also excluded. Studies evaluating benzodiazepines analogues were also excluded. Critical Appraisal of Individual Studies Critical appraisal of the included studies was based on study design. The methodological quality of the included randomized controlled trials was evaluated using the SIGN50 checklist for the controlled studies.12 The observational studies included in this review were evaluated using the SIGN50 checklist for the cohort studies.13 For the included studies a numeric score was not calculated. Instead, the strengths and limitations of each study were described. SUMMARY OF EVIDENCE Quantity of Research Available A total of 348 potential citations were identified by the search in bibliographic database, with 328 citations being excluded during the title and abstract screening based on irrelevance to the questions of interest. The full text documents of the remaining 20 articles were retrieved. Of these 20 articles, 15 did not meet the inclusion criteria and were excluded, leaving five articles that reported from five unique studies to be included in this review.1,4,8,9,11 The literature search did not identify any relevant health technology assessments, systematic reviews, meta-analyses or evidence-based clinical guidelines. A PRISMA diagram demonstrating the study selection process is presented in APPENDIX 1. Summary of Study Characteristics Five studies that addressed at least one of the two review questions about the safety of high and watchful doses of benzodiazepine were included in this review, including two RCTs evaluating efficacy and safety of the perioperative use of different doses of midazolam,1,8 one RCT that assessed the bioavailability and safety of different doses of diazepam in healthy volunteers,4 and two observational studies evaluating the safety of a high-dose midazolam Watchful Dosing of Benzodiazepines 3 sedation protocol9 and the safety of long-term use of benzodiazepines in high doses.11 Details regarding primary study characteristics are tabulated in APPENDIX 2. Eren et al.1 and Talebi et al.8 conducted two RCTs in perioperative settings. The first trial evaluated the efficacy of dexmedetomidine in preoperative sedation. The trial treatment was compared against placebo and three doses of midazolam (0.02, 0.04, and 0.06 mg/kg) in an open-label design. The study evaluated the above interventions in patients undergoing minor to moderate surgical procedures under general anesthesia. The second trial evaluated the effects of intrathecal lidocaine on post-operative pain among male patients undergoing elective ipsilateral open inguinal herniorrhaphy under spinal anesthesia. The trial compared the combination of lidocaine with midazolam (fixed doses; 0.5 mg and 1 mg) to lidaocaine alone. The included patients in both trials were classified group I-II according to the American Society of Anesthesiologists (ASA). Group I-II ASA is defined as normal healthy patients or patients with mild systemic disease with no functional limitation.1,8 The bioavailability and safety of intramuscular (IM) auto-injected diazepam was evaluated in healthy volunteers in an open-label, single-dose and crossover RCT.4 Three doses of diazepam (5, 10 and 15 mg) were compared to each other; the 10 mg diazepam administered
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