Jennifer A. Watt, MD, PhD1,2,3,4, Susan E. Bronskill, PhD3,4, Meng Lin5, Erik Youngson, MMath5, Joanne Ho, MD, MSc6,7, Brenda Hemmelgarn, MD, PhD8, Sharon E. Straus, MD, MSc1,2,4, Andrea Gruneir, PhD9
1Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael’s Hospital-Unity Health Toronto, Toronto, ON
2Division of Geriatric Medicine, Department of Medicine, University of Toronto, Toronto, ON
3ICES, Toronto, ON
4Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON
5Data and Research Services, Alberta SPOR Support Unit and Provincial Research Data Services, Alberta Health Services, Edmonton, AB
6Division of Geriatric Medicine, Department of Medicine, McMaster University, Kitchener, ON
7Schlegel Research Institute for Aging, University of Waterloo, Waterloo, ON
8Faculty of Medicine and Dentistry, University of Alberta, WC Mackenzie Health Sciences Centre, Edmonton, AB
9Department of Family Medicine, University of Alberta, Edmonton, ABDOI: https://doi.org/10.5770/cgj.26.575
ABSTRACT
Background
There is growing evidence of harm associated with trazodone and nonbenzodiazepine sedative hypnotics (e.g., zopiclone); however, their comparative risk of harm is unknown.
Methods
We conducted a retrospective cohort study with linked health administrative data, which enrolled older (≥66 years old) nursing home residents living in Alberta, Canada, between December 1, 2009, and December 31, 2018; the last follow-up date was June 30, 2019. We compared the rate of injurious falls and major osteoporotic fractures (primary outcome) and all-cause mortality (secondary outcome) within 180 days of first prescription of zopiclone or trazodone with cause-specific hazard models and inverse probability of treatment weights to control for confounding; primary analysis was intention-to-treat and secondary analysis was per-protocol (i.e., residents censored if dispensed the other exposure drug).
Results
Our cohort included 1,403 residents newly dispensed trazodone and 1,599 residents newly dispensed zopiclone. At cohort entry, the mean resident age was 85.7 (standard deviation [SD] 7.4), 61.6% were female, and 81.2% had dementia. New zopiclone use was associated with similar rates of injurious falls and major osteoporotic fractures (intention-to-treat-weighted hazard ratio 1.15, 95% confidence interval [CI] 0.90–1.48; per-protocol-weighted hazard ratio 0.85, 95% CI 0.60–1.21) and all-cause mortality (intention-to-treat-weighted hazard ratio 0.96, 95% CI 0.79–1.16; per-protocol-weighted hazard ratio 0.90, 95% CI 0.66–1.23) compared to trazodone.
Conclusions
Zopiclone was associated with a similar rate of injurious falls, major osteoporotic fractures, and all-cause mortality compared to trazodone—suggesting one medication should not be used in lieu of the other. Appropriate prescribing initiatives should also target zopiclone and trazodone.
Key words: adverse drug event, trazodone, zopiclone, cohort studies
Older adults living in nursing homes commonly experience neuropsychiatric symptoms such as sleep disturbances and agitation.(1) Pharmacologic interventions such as antipsychotics, antidepressants, benzodiazepines, and nonbenzodiazepines sedative hypnotics (i.e., z-drugs) are prescribed to treat these symptoms.(2) The pooled prevalence of chemical (e.g., antipsychotics, benzodiazepines) and physical (e.g., mittens, lap belt) restraint use in a systematic review of nursing home prevalence estimates was 32% and 33%, respectively.(3) Efficacious alternatives to chemical and physical restraints include massage therapy, music therapy, and multidisciplinary care plans; however, health-care provider knowledge of these interventions and resource limitations are perceived as barriers to their implementation.(4–6)
Time trend analyses conducted before the COVID-19 pandemic in Canada, the United States, and the United Kingdom suggested that antipsychotic and benzodiazepine use was stabilizing or decreasing, but use of alternative psychotropic medications such as antidepressants and anticonvulsants was increasing.(7–9) For example, 21.3% of older adults living in nursing homes in Ontario, Canada, were dispensed trazodone in 2013, compared to only 7.7% in 2002, which may have been in response to a growing body of literature describing harms associated with antipsychotic and benzodiazepine use, and initiatives targeting their appropriate prescribing.(10) From 2011 to 2014, 39.8% of older adults living in nursing homes in Oslo municipality, Norway, were prescribed nonbenzodiazepine sedative hypnotics (i.e., zopiclone or zolpidem); other studies have shown that nonbenzodiazepine sedative hypnotic use in people with dementia varies considerably by country.(2,11,12) Unlike benzodiazepines and antipsychotics, quality improvement work aimed at reducing potentially inappropriate prescribing of these alternative psychotropic medications has been limited.(13–15) This is important because there is growing evidence describing the risk of falls and fractures in older adults dispensed trazodone and nonbenzodiazepine sedative hypnotics (e.g., zopiclone).(16–18) Further, trazodone is associated with a similar risk of harm from injurious falls or fractures as benzodiazepines and atypical antipsychotics.(16,17)
Despite how commonly trazodone and zopiclone are prescribed in nursing homes, their comparative risk of harm in nursing home residents is unknown.(2,10) Our objective was to describe the risk of harm from injurious falls, fractures, and death associated with new use of zopiclone compared to new use of trazodone among older adults living in nursing homes in Alberta, Canada.
This manuscript is reported in accordance with the STROBE (strengthening the reporting of observational studies in epidemiology) and RECORD-PE (reporting of studies conducted using observational routinely collected health data—pharmacoepidemiology) statements.(19, 20)
We created our cohort using linked health administrative databases in Alberta, Canada. Alberta has a largely publicly funded health-care system, in which individuals aged 65 years or older can access publicly funded nursing homes, when necessary, and receive universal coverage for physician services and most prescription medications. Between April 1, 2016, and March 31, 2017, there were 20,073 residents living in nursing homes in Alberta, and each resident received 10 different medications in the seven days before their Resident Assessment Instrument—Minimum Data Set, version 2.0 (RAI-MDS 2.0) assessment.(21) We linked patient-level data from these databases using each patient’s health insurance program number: National Ambulatory Care Reporting System, Provincial Registry, Discharge Abstract Database, Practitioner Claims Database, Pharmacy Information Network, and the Alberta Continuing Care Information System (see Appendix A for database details). These databases are accurate and reliable.(22–24)
In this retrospective cohort study, the date of a new prescription for oral trazodone or zopiclone between December 1, 2009, and December 31, 2018, was our index date. We included nursing home residents, aged 66 years or older, who received a full RAI-MDS 2.0 assessment within 45 days before our index date. The RAI-MDS 2.0 is a validated assessment tool that records information about residents’ health status (e.g., independence in activities of daily living and cognitive impairment severity).(25) Choosing assessments within 45 days of the index date ensured a close temporal association between drug exposure and residents’ current health status. Our observation window was 180 days, which balanced the time required for event accrual against a need to minimize residual confounding over time. The maximum follow-up date was June 30, 2019. We excluded residents from our cohort if they: 1) did not have a complete Resident Assessment Instrument—Minimum Data Set, version 2.0 assessment within 45 days prior to cohort entry; 2) had an invalid identifying number or died on or before the index date; 3) had no drug claims in the year prior to cohort entry; 4) were dispensed trazodone or zopiclone in the 180 days prior to cohort entry; 5) were newly dispensed both trazodone and zopiclone on the index date; 6) received palliative care services in the 180 days prior to cohort entry; or 7) were dispensed trazodone at a dose greater than 300 mg/day or zopiclone at a dose greater than 15 mg/day (see Figure 1).
We defined our primary outcome as a composite of fall-related emergency department visit (i.e., injurious fall) or major osteoporotic fracture, defined as a hip, pelvis, humerus, or forearm fracture (see Appendix B).(26) These outcomes are identified with a high positive predictive value in administrative databases and high level of agreement during medical chart re-abstraction.(22,26,27) Our secondary outcome was all-cause mortality. Where numbers permitted, we planned to report primary outcome components (i.e., fall, hip fracture, major osteoporotic fracture) as secondary outcomes. See Appendix A for all International Classification of Diseases, Tenth Revision (ICD-10) codes used to define residents’ baseline characteristics and study outcomes.(22,23,26)
We summarized categorical baseline characteristics as frequencies (and percentages) and compared across exposure groups with chi-square tests. We summarized continuous baseline characteristics as means (and SDs) and compared across exposure groups with independent t-tests. We reported the proportion of residents missing data for individual baseline characteristics.
We derived inverse probability of treatment weights from an estimated propensity score, which we derived by regressing exposure status on baseline covariates (see Appendix B for covariates), including medications dispensed in the year before cohort entry. In our study, the propensity score was the probability that a resident would be dispensed trazodone or zopiclone, conditional on their baseline characteristics.(28) We included missing values for categorical variables as an additional category. There were no missing values for continuous variables. We modeled the average treatment effect because we could foresee any cohort member potentially receiving either exposure drug and we wished to understand the average effect of treatment in the entire cohort.(29) Treatment weights were inspected for outlying values (greater than 50).(30) Crude (i.e., unweighted) and weighted cause-specific hazard ratios comparing outcome rates associated with zopiclone or trazodone use were derived from cause-specific hazards models, because we wanted to understand the association between our exposure and outcome rate in residents who had not yet had an outcome and were, therefore, at risk of having an outcome.(31) Weighted cause-specific hazards models were adjusted for all baseline characteristics for which there were statistically significant differences (i.e., p<.05) between exposure groups. We verified that hazard ratios did not vary over time, and we used robust standard errors to account for within-subject homogeneity in outcomes induced by weighting.(32)
Our primary analyses were based on an intention-to-treat principle (i.e., residents who were newly dispensed either exposure drug remained in the cohort even if they were dispensed the other exposure drug during the follow-up period); residents were followed until the first of the outcome of interest, death, or 180 days after index date. In secondary analyses, we censored residents who were dispensed the other exposure drug during the 180-day follow-up period (i.e., per protocol). We reported weighted incidence rates as the number of events per 100 person-years. Where numbers permitted, we planned to conduct subgroup analyses based on residents’ age, sex, dementia severity, and concurrent antipsychotic prescription. Analyses were conducted with SAS (version 9.4; Cary, NC) and STATA SE (version 13.0; StataCorp LP, College Station, TX).
We obtained ethics approval for this study from the University of Alberta Research Ethics Board (Pro00091328).
We included 3,002 residents in our study cohort: 1,403 residents were newly dispensed trazodone, and 1,599 residents were newly dispensed zopiclone (Figure 1). The median total daily dose of zopiclone was 7.5 mg (interquartile range 3.75 mg to 7.5 mg) and trazodone was 25 mg (interquartile range 25 mg to 50 mg). There were no outlying inverse probability of treatment weights. After applying inverse probability of treatment weights, exposure groups were similar at baseline (Table 1 and Table B1 in Appendix B). The mean age of residents on the date of cohort entry was 85.7 (SD 7.4), 61.6% were female, and 81.2% had a diagnosis of dementia.
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FIGURE 1 Flow diagram of cohort creation
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TABLE 1 Baseline characteristics of a cohort of older adults dispensed trazodone or zopiclone (number [n] =3,002)
In both intention-to-treat and per-protocol analyses, residents newly dispensed zopiclone experienced a similar rate of falls and major osteoporotic fractures compared to residents newly dispensed trazodone (crude hazard ratio 0.89, 0.70 to 1.13; intention-to-treat-weighted hazard ratio 1.15, 95% CI 0.90 to 1.48; per-protocol-weighted hazard ratio 0.85, 95% CI 0.60 to 1.21) (Table 2). Similarly, residents newly dispensed zopiclone experienced a similar rate of all-cause mortality compared to residents newly dispensed trazodone (crude hazard ratio 0.96, 95% CI 0.82 to 1.13; intention-to-treat-weighted hazard ratio 0.96, 95% CI 0.79 to 1.16; per-protocol-weighted hazard ratio 0.90, 95% CI 0.66 to 1.23) (Table 2). We did not conduct subgroup analyses because there were too few outcomes in exposure groups.
TABLE 2 Intention-to-treat and per-protocol analyses of the comparative risk of (i) fall or major osteoporotic fracture and (ii) all-cause mortality for new users of zopiclone vs. trazodone within 180 days
In our cohort of older nursing home residents, we found a similar rate of injurious falls, major osteoporotic fractures, and death in residents newly dispensed trazodone or zopiclone. Our findings are important because trazodone is associated with a similar risk of injurious falls and fractures compared to benzodiazepines and atypical antipsychotics, and these outcomes are common and important to residents and the health-care system: the mean incidence of falls in nursing homes is 1.5 falls per bed per year and 4% of falls result in a fracture.(16,17,33) Further, our findings provide direct estimates of the comparative risk of harm associated with trazodone or zopiclone use, which will inform quality improvement initiatives and highlight potential dangers associated with medication substitution as clinicians are discouraged from administering certain medications without having access to feasible and evidence-based alternatives.
There is mounting evidence of harm associated with trazodone and zopiclone use in older adults.(16–18) Trazodone is associated with a similar risk of harm from injurious falls or fractures as benzodiazepines or atypical antipsychotics.(16,17) Similarly, a systematic review and meta-analysis describing harms associated with nonbenzodiazepine sedative hypnotic use in older adults identified an increased risk of fractures and injuries, but it did not identify an increased risk of falls associated with their use.(18) However, a subsequent cohort study by Westerlind and colleagues identified an increased risk of falls associated with zopiclone or zolpidem use.(34) Our findings bridge the gap between these bodies of literature to show that trazodone and zopiclone are associated with a similar risk of harm in nursing home residents. Further, our findings, combined with the work of others, demonstrate that trazodone, zopiclone, atypical antipsychotics, and benzodiazepines are all associated with a similar risk of harm from injurious falls and fractures in this patient population.(16,17)
Unlike benzodiazepines and antipsychotics, there has been less research directed at reducing the potentially inappropriate prescribing of alternative psychotropic medications, such as trazodone and nonbenzodiazepines sedative hypnotics (i.e., z-drugs), despite growing evidence of harm associated these alternative psychotropic medications.(13–15,35) A multi-hospital study demonstrated that a sedative-hypnotic reduction quality improvement bundle, which consisted of order set changes, audit feedback, pharmacist-enabled medication reviews, sleep hygiene, daily sleep huddles, and education, decreased benzodiazepine and nonbenzodiazepine sedative hypnotic use.(35) Other potentially efficacious interventions that could be implemented instead of psychotropic medications include multidisciplinary care, massage and touch therapy, outdoor activities, and cognitive stimulation. However institution- and individual-level barriers, including perceived lack of effectiveness, lack of knowledge of the dangers associated with psychotropic medication use, inadequate staffing, and clinician attitudes towards neuropsychiatric symptom management, prevent their widespread use.(6,36–40) Institution-level (e.g., hospitals, non-profit organizations, nursing homes) policies that 1) establish an interprofessional team responsible for psychotropic medication stewardship; 2) agree on psychotropic medication appropriateness criteria, educate care staff; 3) inform and involve family and friend carers; 4) establish a regular medication review process; 5) discontinue potentially inappropriate medications; and 6) implement nonpharmacologic interventions are needed to ensure that inappropriate administration of psychotropic medications is minimized, and feasible nonpharmacologic alternative interventions are available.(41)
Our study has limitations. The nonrandomized study design means there are potential residual confounders that could influence our results; however, we 1) used comprehensive RAI-MDS 2.0 data containing information about resident health status, including functional and cognitive impairment; 2) restricted our cohort to a population of older nursing home residents (in Alberta, Canada, where residents are supported in completing basic and instrumental activities of daily living, which ensures they receive medications); and 3) utilized a propensity score to balance between-group differences. We also limited our definition of falls to those requiring transfer to hospital (i.e., injurious falls), which means our reported estimate of falls or major osteoporotic fractures per 100 person-years is likely an underestimate of true incidence.
We found that zopiclone use was associated with a similar rate of injurious falls, major osteoporotic fractures, and all-cause mortality compared to trazodone in older nursing home residents. Our findings suggest that quality improvement initiatives should target trazodone and nonbenzodiazepine sedative hypnotic use in older adults, in addition to benzodiazepine and antipsychotic use; trazodone and zopiclone, despite their potential for harm, are not currently targeted by many of these initiatives.(2,10,14,35,42) Our findings, combined with earlier research, suggest that 1) trazodone, zopiclone, benzodiazepines, and atypical antipsychotics are all similarly harmful in older adults with respect to a risk of falling or sustaining a fracture; 2) trazodone and zopiclone should also be targeted by quality improvement initiatives to decrease their inappropriate use; 3) further comparative safety research is needed on other psychotropic medications to inform decision-making for patients and caregivers that will help them understand the risks and benefits of choosing pharmacologic or nonpharmacologic interventions for reducing neuropsychiatric symptoms; and, 4) greater resources should be dedicated to implementing feasible nonpharmacologic interventions to antipsychotics and benzodiazepines in nursing homes so we can avoid inappropriate substitution of potentially harmful alternative medications.(16–18,34)
Not applicable.
We have read and understood the Canadian Geriatrics Journal’s policy on conflicts of interest disclosure and declare there are no conflicts of interest.
This research did not receive any funding from agencies in the public, commercial, or not-for-profit sectors. In-kind support was provided by the Alberta SPOR Support Unit Data and Research Services team.
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TABLE B1 Complete baseline characteristics of a cohort of older adults dispensed trazodone or zopiclone (number [n] =3,002)
Canadian Geriatrics Journal, Vol. 26, No. 1, March 2023