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Non-GABA sleep medications, suvorexant as risk factors for falls: Case-control and case-crossover study.

ABSTRACT: The aim of this study was to examine the risk of falls associated with the use of non-gamma amino butyric acid (GABA) sleep medications, suvorexant and ramelteon. This case-control and case-crossover study was performed at the Kudanzaka Hospital, Chiyoda Ward, Tokyo. A total of 325 patients who had falls and 1295 controls matched by sex and age were included. The inclusion criteria for the case group were hospitalized patients who had their first fall and that for the control were patients who were hospitalized and did not have a fall, between January 2016 and November 2018. The internal sleep medications administered were classified as suvorexant, ramelteon, non-benzodiazepines, benzodiazepines, or kampo. In the case-control study, age, sex, clinical department, the fall down risk score, and hospitalized duration were adjusted in the logistic regression model. In the case-control study, multivariable logistic regression showed that the use of suvorexant (odds ratio [OR]: 2.61, 95% confidence interval [CI]: 1.29-5.28), nonbenzodiazepines (OR: 2.49, 95% CI: 1.73-3.59), and benzodiazepines (OR: 1.65, 95% CI: 1.16-2.34) was significantly associated with an increased OR of falls. However, the use of ramelteon (OR: 1.40, 95% CI: 0.60-3.16) and kampo (OR: 1.55, 95% CI: 0.75-3.19) was not significantly associated with an increased OR of falls. In the case-crossover study, the use of suvorexant (OR: 1.78, 95% CI: 1.05-3.00) and nonbenzodiazepines (OR: 1.63, 95% CI: 1.17-2.27) was significantly associated with an increased OR of falls. Similar patterns were observed in several sensitivity analyses. It was suggested that suvorexant increases the OR of falls. This result is robust in various analyses. This study showed that the risk of falls also exists for non-GABA sleep medication, suvorexant, and thus it is necessary to carefully prescribe hypnotic drugs under appropriate assessment.

SUBMITTER: Ishibashi Y

PROVIDER: S-EPMC7486134 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Non-GABA sleep medications, suvorexant as risk factors for falls: Case-control and case-crossover study.

Ishibashi Yoshiki Y Nishitani Rie R Shimura Akiyoshi A Takeuchi Ayano A Touko Mamoru M Kato Takashi T Chiba Sahoko S Ashidate Keiko K Ishiwata Nobuo N Ichijo Tomoyasu T Sasabe Masataka M

PloS one 20200911 9

The aim of this study was to examine the risk of falls associated with the use of non-gamma amino butyric acid (GABA) sleep medications, suvorexant and ramelteon. This case-control and case-crossover study was performed at the Kudanzaka Hospital, Chiyoda Ward, Tokyo. A total of 325 patients who had falls and 1295 controls matched by sex and age were included. The inclusion criteria for the case group were hospitalized patients who had their first fall and that for the control were patients who w ...[more]

PMID: 32916693

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Project description:BackgroundMedications influencing the risk of fall-related injuries (FRIs) in older adults have been inconsistent in previous guidelines. This study employed case-control design to assess the association between FRIs and medications, and an additional case-crossover design was conducted to examine the consistency of the associations and the transient effects of the medications on FRIs.MethodsThis study was conducted using a national claims database (2002-2015) in Korea. Older adults (≥ 65 years) who had their first FRI between 2007 and 2015 were matched with non-cases in 1:2 ratio. Drug exposure was examined for 60 days prior to the date of the first FRI (index date) in the case-control design. The hazard period (1-60 days) and two control periods (121-180 and 181-240 days prior to the index date) were investigated in the case-crossover design. The risk of FRIs with 32 medications was examined using conditional logistic regression after adjusting for other medications that were significant in the univariate analysis. In the case-crossover study, the same conditional model was applied.ResultsIn the case-control design, the five medications associated with the highest risk of FRIs were muscle relaxants (adjusted odd ratio(AOR) = 1.35, 95% confidence interval (CI) = 1.31-1.39), anti-Parkinson agents (AOR = 1.30, 95%CI = 1.19-1.40), opioids (AOR = 1.23, 95%CI = 1.19-1.27), antiepileptics (AOR = 1.19, 95%CI = 1.12-1.26), and antipsychotics (AOR = 1.16, 95%CI = 1.06-1.27). In the case-crossover design, the five medications associated with the highest risk of FRIs were angiotensin II antagonists (AOR = 1.87, 95%CI = 1.77-1.97), antipsychotics (AOR = 1.63, 95%CI = 1.42-1.83), anti-Parkinson agents (AOR = 1.58, 95%CI = 1.32-1.85), muscle relaxants (AOR = 1.42, 95%CI = 1.35-1.48), and opioids (AOR = 1.35, 95%CI = 1.30-1.39).ConclusionsAnti-Parkinson agents, opioids, antiepileptics, antipsychotics, antidepressants, hypnotics and sedatives, anxiolytics, muscle relaxants, and NSAIDs/antirheumatic agents increased the risk of FRIs in both designs among older adults. Medications with a significant risk only in the case-crossover analysis, such as antithrombotic agents, calcium channel blockers, angiotensin II antagonists, lipid modifying agents, and benign prostatic hypertrophy agents, may have transient effects on FRIs at the time of initiation. Corticosteroids, which were only associated with risk of FRIs in the case-control analysis, had more of cumulative than transient effects on FRIs.

Project description:BackgroundThis study aimed to determine whether the number of anti-hypertensive medication classes or any change in anti-hypertensive medication were associated with injurious fall among the community-dwelling older population of low socioeconomic status.MethodsUsing data from electronic medical records, we performed a nested case-control study among older Singapore residents (≥60) of low socioeconomic status (N = 210). Controls (n = 162) were matched to each case (n = 48) by age and gender. Variables with p < 0.10 in univariate analysis were included in multivariate analysis. We used conditional logistic regression to assess the associations of the number of anti-hypertensive medication classes and change in anti-hypertensive medication with injurious falls. We also performed stepwise regressions as sensitivity analyses. p < 0.05 was considered statistically significant.ResultsThe mean (±SD) age of participants was 78.1 (± 8.33) years; 127 (60.4%) were female, 189 (90.0%) were Chinese. Those on ≥2 anti-hypertensive medication classes had an increased risk of experiencing an injurious fall compared to those not on any anti-hypertensive medication (OR = 5.45; CI:1.49-19.93; p = 0.01). Among those who were taking anti-hypertensive medication, those who had a change in the medication 180-day prior to injurious fall had a significantly increased risk of experiencing an injurious fall compared to those that did not report any change in anti-hypertensive medication (OR = 3.88; CI:1.23-12.19; p = 0.02). Sensitivity analyses generated consistent findings.ConclusionBoth ≥2 anti-hypertensive medication classes and change in anti-hypertensive medication were associated with an increased risk of experiencing an injurious fall among the older population of low socioeconomic status. Our findings could guide prescribers to exercise caution in the initiation of anti-hypertensive medications or in making medication changes, especially among the older population of low socioeconomic status.

Project description:BackgroundPatient falls are considered a challenge to the patient's safety in hospitals, which, in addition to increasing the length of stay and costs, may also result in severe injuries or even the death of the patient. This study aims to investigate the associations between risk factors among fallers in comparison with the control group.MethodsA prospective nested case control study was performed on 185 patients who fell and 1141 controls were matched with the patients at risk of fall in the same ward and during the same time. This study was conducted in a university educational hospital in Tehran with 800 beds during a 9-month period. The data included demographics, comorbidities, admission details, types of medication, clinical conditions, and activities before or during the fall. The data was collected from clinical records, hospital information system, error reporting system and observations, and the interviews with the fallers, their families and care givers (physicians, nurses, etc). Data analysis was conducted through time-based matching using a multi-level analysis.ResultsIn a multilevel model including patient-related, medication, and care-related variables, the factors that were significantly associated with an increased risk of patient falls included: longer length of stay (odds ratio [OR] = 1.01; CI=0.32 to 0.73), using chemotherapy drugs, sedatives, anticonvulsants, benzodiazepines, and angiotensin-converting enzyme (ACE) inhibitors, visual acuity (OR=6.93; CI=4.22 to 11.38), balance condition (OR= 6.41; CI=4.51 to 9.11), manual transfer aid (OR=8.47; CI=5.65 to 12.69), urinary incontinence (OR= 8.47, CI= 5.65 to 12.69), and cancer (OR=2.86, CI=1.84-4.44). These factors were found to be associating with more odds for a falling accident among patients. Several characteristics such as fall history (OR=0.48; CI= 1.003 to 1.02), poly-pharmacy (OR=1.37, CI=00.85 to 2.2), stroke (OR=0.94, CI= 0.44 to 2.02), and nurse to patient ratio (incidence rate ratio=1.01, CI=0.01 to 0.03) were not significantly associated with falling in hospitals.ConclusionIt seems that a combination of both patient-related factors and history of medication should be considered. Moreover, modifiable clinical characteristics of patients such as vision improvement, provision of manual transfer aid, diabetes control, regular toilet program, and drug modification should be considered during the formulation of interventions.

Project description:Study objectivesThe chronic pain disorder, fibromyalgia, is associated with sleep disturbance, typically sleep maintenance. No studies have evaluated the effect of sleep medication on pain sensitivity in this population. Suvorexant, an orexin antagonist approved for treatment of insomnia, was evaluated for effects on both sleep and the pain of fibromyalgia.MethodsWomen age 21 to 65 years with fibromyalgia and comorbid insomnia (n = 10) were treated, double-blind, for 9 nights each with suvorexant, 20 mg and placebo in counterbalanced order. All were in good psychiatric and stable physical health and met American College of Rheumatology 2010 criteria for fibromyalgia and Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition criteria for insomnia. Screening 8-hour polysomnography (PSG) was used to rule out other sleep disorders. On nights 8 and 9 of each treatment 8-hour PSG were collected and on days 1 and 8 pain sensitivity was assessed at 1100 and 1500 hours by measuring finger withdrawal latency (FWL) to a radiant heat stimulus at 5 randomly presented intensity levels.ResultsSuvorexant versus placebo increased total sleep time (7.2 versus 6.7 hours, P < .05) and reduced wake after sleep onset (37 versus 67 minutes, P < .04) with no night effects or interaction. Latency to persistent sleep and sleep stage measures were not altered. FWL on both am and pm tests varied as a function of intensity (P < .001). Average FWL (over 5 intensities and both days) was increased relative to placebo on both the am (13.9 versus 13.1 seconds) and pm tests (15.8 versus 14.1 seconds, P < .03) following suvorexant the previous night.ConclusionsSuvorexant 20 mg in patients with fibromyalgia, improved sleep time and reduced next-day pain sensitivity on assessments of FWL to a radiant heat stimulus.Clinical trial registryRegistry: ClinicalTrials.gov; Name: A double-blind cross-over, study to compare the hypnotic, daytime sleepiness/fatigue, and pain effects of nighttime administration of suvorexant 20 mg versus placebo in patients with fibromyalgia and comorbid insomnia; Identifier: NCT02684136; URL: https://clinicaltrials.gov/ct2/show/NCT02684136.

Project description:BackgroundImpact of immeasurable time bias (IMTB) is yet to be examined in self-controlled designs.MethodsWe conducted case-crossover, case-time-control, and case-case-time-control analyses using Korea's healthcare database. Two empirical examples among elderly patients were used: 1) benzodiazepines-hip fracture; 2) benzodiazepines-mortality. For cases, the date of hip fracture diagnosis or death was defined as the index date, and the inherited date of their matched cases for controls or future cases. Exposure was assessed in the 1-30 day (hazard) and 61-90 day (control) windows preceding the index date. A non-missing exposure setting included in- and outpatient prescriptions and the pseudo-outpatient setting included only the outpatients. Conditional logistic regression was done to estimate odds ratios (ORs) with 95% confidence intervals (CIs), where the relative difference in OR among the two settings was calculated to quantify the IMTB.ResultsThe IMTB had negligible impacts in the hip fracture example in the case-crossover (non-missing exposure setting OR 1.27; 95% CI, 1.12-1.44; pseudo-outpatient setting OR 1.21; 95% CI, 1.06-1.39; magnitude 0.05), case-time-control (OR 1.18; 95% CI, 0.98-1.44; OR 1.13; 95% CI, 0.92-1.38; 0.04, respectively), and case-case-time-control analyses (OR 0.99; 95% CI, 0.80-1.23; OR 0.94; 95% CI, 0.75-1.18; 0.05, respectively). In the mortality example, IMTB had significant impacts in the case-crossover (non-missing exposure setting OR 1.44; 95% CI, 1.36-1.52; pseudo-outpatient setting OR 0.72; 95% CI, 0.67-0.78; magnitude 1.00), case-time-control (OR 1.38; 95% CI, 1.26-1.51; OR 0.68; 95% CI, 0.61-0.76; 1.03, respectively), and case-case-time-control analyses (OR 1.27; 95% CI, 1.15-1.40; OR 0.62; 95% CI, 0.55-0.69; 1.05, respectively).ConclusionAlthough IMTB had negligible impacts on the drug's effect on acute events, as these are unlikely to be accompanied with hospitalizations, it negatively biased the drug's effect on mortality, an outcome with prodromal phases, in the three self-controlled designs.

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Non-GABA sleep medications, suvorexant as risk factors for falls: Case-control and case-crossover study.

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Non-GABA sleep medications, suvorexant as risk factors for falls: Case-control and case-crossover study.

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