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For Peer Review Only BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from Pharmacologic interventions to improve sleep in hospitalized adults: A systematic review ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2016-012108 Article Type: Research Date Submitted by the Author: 07-Apr-2016 Complete List of Authors: Kanji, Salmaan; The Ottawa Hospital, Pharmacy and Critical Care; The Ottawa Hospital Research Institute, Clinical Epidemiology Mera, Alexandru; The Ottawa Hospital, Pharmacy Hutton, Brian; University of Ottawa, Ottawa, Ontario, Canada, Clinical Epidemiology; The Ottawa Hospital Research Institute, Clinical Epidemiology Burry, Lisa; Mount Sinai Hospital, Pharmacy Rosenberg, Erin; The Ottawa Hospital, Critical Care MacDonald, Erika; The Ottawa Hospital, Pharmacy; The Ottawa Hospital Research Institute, Clinical Epidemiology Luks, Vanessa; Thunder Bay Regional Health Sciences Centre, Respirology <b>Primary Subject Pharmacology and therapeutics Heading</b>: http://bmjopen.bmj.com/ Secondary Subject Heading: Epidemiology, Evidence based practice, Respiratory medicine SLEEP MEDICINE, CLINICAL PHARMACOLOGY, Sleep medicine < Keywords: ANAESTHETICS on September 30, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 54 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from 1 2 3 4 Pharmacologic interventions to improve sleep in hospitalized 5 6 adults: A systematic review 7 8 *Salmaan Kanji, Pharm D. 9 Departments of Pharmacy and Critical Care, The Ottawa Hospital 10 11 The Ottawa Hospital Research Institute 12 13 *Alexandru Mera, B.Sc. Pharm., ACPR 14 Department of Pharmacy, Hôpital Montfort - The Ottawa Hospital 15 For peer review only 16 Brian Hutton, MSc, PhD 17 18 Ottawa Hospital Research Institute 19 University of Ottawa School of Epidemiology, Public Health and Preventative Medicine 20 21 Lisa Burry, Pharm D. 22 Department of Pharmacy, Mount Sinai Hospital 23 24 University of Toronto 25 26 Erin Rosenberg, BSc., MD, MHA, FRCP(c) 27 Department of Critical Care, The Ottawa Hospital 28 29 Erika MacDonald, B.Sc. Pharm., ACPR, M.Sc, RPh 30 31 Department of Pharmacy, The Ottawa Hospital 32 The Ottawa Hospital Research Institute 33 http://bmjopen.bmj.com/ 34 Vanessa Luks 35 BASc, MD, FRCP(c), 36 37 Department of Respirology, Thunder Bay Regional Health Sciences Centre, 38 Northern Ontario School of Medicine 39 40 41 on September 30, 2021 by guest. Protected copyright. 42 *Dr. Kanji and Mr. Mera contributed equally to this work and would like to be recognized as co- 43 44 primary authors. Dr. Kanji is the corresponding author. 45 46 47 Corresponding Author: Salmaan Kanji 48 The Ottawa Hospital 49 50 501 Smyth Rd 51 Ottawa, Ontario, Canada 52 K1H 8L6 53 [email protected] 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 54 2 BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from 1 2 3 4 5 6 Abstract 7 8 Objectives: Patients often suffer from disturbed sleep in hospital. Poor quality sleep in 9 10 11 hospitalized patients has been associated with significant morbidity and pharmacological sleep 12 13 aids are often prescribed. The objective of this systematic review is to evaluate the comparative 14 15 efficacy and safetyFor of pharmacologic peer interventions review used for sleep only in hospitalized patients. 16 17 18 19 Setting/Participants: We searched Medline, EMBASE, the Cochrane database and grey 20 21 literature for prospective studies that evaluated sleep in hospitalized adults after a pharmacologic 22 23 24 intervention. 25 26 27 28 Primary and Secondary Outcome Measures: Two reviewers assessed studies for inclusion and 29 30 31 extracted data for efficacy outcomes including sleep efficiency, sleep latency, sleep 32 33 fragmentation and objectively measured sleep stage distribution. Risk of bias was assessed and http://bmjopen.bmj.com/ 34 35 meta-analyses were planned contingent upon homogeneity of the included studies. 36 37 38 39 Results: After screening 1920 citations, 15 studies involving 861 patients were included. 40 41 Medications studied included benzodiazepines, nonbenzodiazepine sedatives, melatonin, on September 30, 2021 by guest. Protected copyright. 42 43 44 propofol, and dexmedetomidine. Five studies were deemed to be of high quality. Heterogeneity 45 46 and variable outcome reporting precluded meta-analysis in most cases. No consistent trends with 47 48 respect to sleep efficiency, quality or interruptions were observed identifying one drug or drug 49 50 51 class as superior to another or no treatment. Benzodiazepines appeared to be better than no 52 53 treatment with respect to sleep latency. Sleep stage distribution shows that sleep in hospital is 54 55 dominated by stage N1 and N2. 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 54 BMJ Open 3 BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from 1 2 3 Conclusion: There is insufficient evidence to suggest that pharmacotherapy improves the quality 4 5 6 or quantity of sleep in hospitalized patients suffering from poor sleep. No drug class or specific 7 8 drug was identified as superior even when compared to placebo or no treatment except for the 9 10 11 outcome of sleep latency, where benzodiazepines in general appear to outperform placebo or no 12 13 treatment. Although 15 studies were included, the quality of evidence was limited by both their 14 15 quality and size.For Larger, better-designed peer trials review in hospitalized adults only are needed. 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 30, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 54 4 BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from 1 2 3 Article Summary: 4 5 6 • The purpose of this systematic review was to synthesize and summarize the available 7 8 evidence describing the efficacy and safety of drug therapy for sleep in acutely ill adults 9 10 11 in hospital. 12 13 • Our search of the literature identified 15 studies involving 861 patients and investigating 14 15 a varietyFor of sedatives peer and hypnotics review from different drug classes.only 16 17 18 • Studies were typically small and only a minority utilized an objective measure of sleep 19 20 such as polysomography. While it appears that drug therapy may reduce sleep latency it 21 22 23 does not improve the quality of restorative sleep in hospitalized patients. 24 25 26 27 Strengths and limitations of this study 28 29 30 • The strengths of this review included the use of a validated systematic search strategy of 31 32 multiple databases to identify relevant studies. Two investigators performed article 33 http://bmjopen.bmj.com/ 34 screening and data extraction and the research team consisted of physicians, pharmacists, 35 36 37 an epidemiologist/methodologist, a sleep expert and pharmacotherapy specialists. 38 39 • The main limitations of this review are related to the quality of the studies included. The 40 41 on September 30, 2021 by guest. Protected copyright. 42 studies included were typically small and outcomes were often measured subjectively. 43 44 Not all drugs currently being in clinical settings were identified in clinical trials and 45 46 comparative trials were identified without placebo controls for many drugs. Most studies 47 48 49 did not have a standard approach to the evaluation of safety and thus there was 50 51 insufficient data to adequately assess the safety of drug therapy for sleep in hospitalized 52 53 patients. 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 54 BMJ Open 5 BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from 1 2 3 Key Messages: 4 5 6 • Sleep disruption and poor quality sleep is common among hospitalized adults with acute 7 8 illness 9 10 11 • Despite the fact that pharmacotherapy is commonly prescribed in hospital to improve 12 13 sleep there is no evidence that sleep quality or quantity is actually improved with drug 14 15 therapy For peer review only 16 17 18 • The available literature inadequately describes the safety of the drugs commonly 19 20 prescribed for sleep and thus the risk benefit ratio of this common practice is not clearly 21 22 23 in favor of benefit. 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 30, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 54 6 BMJ Open: first published as 10.1136/bmjopen-2016-012108 on 29 July 2016. Downloaded from 1 2 3 Background 4 5 6 Sleep disturbances including difficulty initiating sleep, fragmented and non-restorative 7 8 sleep occur in up to 50% of acutely ill hospitalized patients.1 Sleep deprivation has been 9 10 11 associated with poor wound healing, memory disorders, delayed ventilator weaning, delirium 12 2-5 13 and mortality. Given the frequency of sleep disorders experienced by hospitalized patients and 14 15 their associated outcomes,For interventionspeer to reviewimprove sleep are frequently only attempted.1,6,7 Non- 16 17 18 pharmacologic interventions such as relaxation techniques, regulation of light/noise exposure are 19 20 often tried to counter new onset sleep disorders related to the environment.1,7 However, a 21 22 systematic review of non-pharmacologic interventions for sleep compared to no intervention did 23 24 8 25 not confirm a positive effect, citing a lack of high quality studies.
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