Outline. Disclosure. Sleep and the Elderly 1,2. Background
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1 Geriatric Grand Rounds Tuesday, March 31, 29 12: noon Dr. Bill Black Auditorium Glenrose Rehabilitation Hospital In keeping with Glenrose Rehabilitation Hospital policy, speakers participating in this event have been asked to disclose to the audience any involvement with industry or other organizations that may potentially influence the presentation of the educational material. Disclosure will be done both verbally and using a slide or handout. Visit web sites: for handouts, poster, schedule, subscription: for on-demand archive of previous presentations: Determining in Elderly Patients Admitted to the GRH General Geriatric Rehabilitation Units Dr. Rebecca Leonard GRH Grand Rounds March 31, 29 Disclosure I have no relationship that could be perceived as placing me in a real or apparent conflict of interest in the context of this presentation. Outline Background Research Questions Methodology Results Limitations Discussion Conclusion and Recommendations Sleep and the Elderly 1,2 Background Age related changes lead to decreased night time sleep A 7 year old sleeps 6(7) hours night 1 or 2 hours in daytime naps Changes in circadian rhythms
2 Sleep and the Elderly Increased sleep latency Decreased sleep efficiency Most common insomnia is intermediate Lack of awareness of normal changes Education Reassurance Stedman s Medical Dictionary Inability to sleep in the absence of external impediments such as noise, a bright light, etc., during the period when sleep should normally occur. High prevalence in the elderly 2,3,4 Primary Secondary Medical comorbidities Psychiatric comorbidities Polypharmacy Psychosocial factors 65 and older, n = 9 2,5 12% no sleep complaints > 5% chronic sleep difficulties occurring most of the time Others had occasional difficulties Complaints include: 43% initiating or maintaining sleep 3% nocturnal waking 29% insomnia 25% daytime napping 19% trouble falling asleep 19% waking too early 13% waking without feeling rested Best Practice Guidelines
3 TOPs 1 29 update Management based on behavioural and cognitive non-pharmacologic strategies Pharmaceuticals are adjunctive Short-term or intermittent basis Prevent relapse or exacerbation TOPs To resolve the problem patient must: be active participant in treatment process have regular follow-ups and monitoring evaluate response and motivation Goal is to: provide tools to manage chronic nature of the illness minimize dependence on medications Non-Pharmacologic Therapies Behavioural techniques Sleep hygiene Sleep consolidation Stimulus control Relaxation therapies Cognitive techniques Cognitive behavioural therapy (CBT) Pharmacologic Therapies First-line pharmacotherapy: Highest level of evidence supporting efficacy and safety Pharmacologic Therapies Second-line Pharmacotherapy: Moderate level of formal evidence. Extent of current use and favorable tolerability support use as second-line agents TOPs Refer at 3 months Sleep medicine program Psychologist
4 TOPs Primary insomnia in adults Geriatric patients: While the general principles of the management of primary insomnia apply to all adult patients it is important to note that late life insomnia requires specific interventions not addressed in this guideline. TOPs 17 Geriatric reference - Dr Sonia Anicoli- Israel, PhD, Professor of Psychiatry Most are not primary insomnia, treat comorbidities Z-drugs and melatonin receptor agonists are safe and effective in older adults Behaviour therapy is preferred TOPs Combination pharmacologic and behavioural therapy most effective Advantages: Meds offer short-term respite Behavioural can take >2 weeks for results Disadvantages: Improvements are attributed to the med Undermine development of coping skills Therapeutic Choices (4 th Edition) 11 Canadian Pharmacists Association (23) Primary insomnia Behavioural approaches Secondary insomnia Treat cause Therapeutic Choices (4 th Edition) Short course of hypnotic (< 2 weeks) Use if acute changes in daytime function Zopiclone first line drug May repeat course once, then refer to sleep expert American Sleep Academy Psychological and Behavioural Therapies 1 st Line Pharmacologic Therapies Short term hypnotic treatment Z drugs > short-intermediate acting BD Sedating antidepressants (Trazadone) Combination of above or atypical antipsychotics
5 American Sleep Academy Use lowest effective dose Taper and discontinue as able Only long term in severe or refractory insomnia or chronic co-morbid illness with consistent follow-up Zopiclone 12,13,14,15 Short acting hypnotic Pharmacological profile similar to benzodiazepines Bind selectively to the α1 subunit of the GABA receptor Induce sedation more selectively Zopiclone Recommended dose in adults 5 to 7.5 mg ½ life elimination 5 hours Recommended dose in seniors 3.75 mg, may increase to 5 to 7.5 mg ½ life elimination 7-8 hours Hepatic insufficiency hours Zopiclone 18,19,2,21,22,23,24,25 Alters postural stability, increased fall risk Residual effects on driving, divided attention Short term memory impairment, memory storage during sleep, rebound insomnia Improve sleep quality NNT = 13 Adverse effect NNT = 6 Zopiclone Reduce sleep latency Increase in total sleep time Less side effects than other pharmaceuticals Research Questions
6 Research Question #1 From a random sample of elderly patients on General Geriatric Rehabilitation Units at the GRH: a. What percentage are on Zopiclone? b. Are there differences in those on Zopiclone vs. those not on Zopiclone? Research Question #2 a. Of those on Zopiclone: i. Were they on it at admission? ii. If not, how many days until it was started? iii. What % were discharged on it? iv. What was the dosage profile? Research Question #2 (Cont d) b. Of those on Zopiclone, how does use profile compare with best practice guidelines? i. Dosing a. If the dosing was daily: Was there a length of use indicated? b. If the dosing was PRN: Was there a doses per week indication? Research Question #2 (Cont d) c. What factors may have influenced prescribing practices? i. Age? ii. Gender? Research Question #3 a. What percentage of patients using Zopiclone were diagnosed with insomnia? b. What percentage of those not using Zopiclone were diagnosed with insomnia? Methodology
7 Methodology Literature review Ethics and site approval Chart retrieval from clinical records Using patients discharged from April 27 to March 28 from all general geriatric rehabilitation units (n = 219) Methodology Retrospective chart review and data extraction including: Demographics Zopiclone use profile Diagnosis of insomnia Methodology Study Sample On Zopiclone Charts No Zopiclone 144 Results Diagnosis 2 No Diagnosis 73 Diagnosis 1 No Diagnosis 143 Demographics (Entire Sample) 219 Charts Mean Age = 8.42 (SD = 7.88) Age Number of Sample % % % 61.2% Gender 38.8% 219 Charts Male Female % 4 2 Zopiclone (34.2%) No Zopiclone (65.8%)
8 Research Question #1 age on Zopiclone What percentage of patients from General Geriatric Rehabilitation Units at the GRH are on Zopiclone? Are there differences in those on Zopiclone vs. those not on Zopiclone? 65.8% 34.2% Zopiclone No Zopiclone Comparison Zopiclone vs. Non-Zopiclone n = 219 On Zopiclone (N = 75) Not on Zopiclone (N = 144) Mean Age (SD) Gender On Zopiclone 8.24 (7.57) Males (65%) Not On Zopiclone 8.51 (8.14) Males (67%) Differences not significant Research Questions related to: On Zopiclone Popoulation Demographics (Zopiclone) Mean Age % (n) 64.6% 35.4% Male (7.53) 37.3% (n = 28) Female 8.64 (8.53) 62.7% (n = 47) Demographics (Zopiclone) Age Number of Sample % % % Differences not significant
9 Research Question #2a On Zopiclone a. Of those on Zopiclone: i. Were they on it on admission? ii. If not, how many days until it was started? iii. What % were discharged on it? iv. What was the dosage profile? In Transfer Orders % on Zopiclone on Admission % not on Zopiclone on Admission 76% 24% Time to Script if not on Zopiclone on Admission Discharge Script 5 45 Mean = 13.8 days st week 2nd Week 3rd Week 4th Week 5th Week 72% 28% Stopped on Discharge Dosing Profile (mg) Admitted Started 1 8 3% 7% Discharged on Zopiclone Stopped Zopiclone 22.3% 77.7% Discharged on Zopiclone Stopped Zopiclone mg 7.5 mg 15 mg
10 Research Question #2b Zopiclone: Frequency of Use b. How does Zopiclone use profile compare with best practice guidelines? i. If the dosing was daily: Was there a length of use indicated? ii. If the dosing was PRN: Was there a doses per week indication? 38.7% 61.3% PRN Daily Zopiclone: Frequency of Use i. If dosing was daily, was there a length of use indicated? Practice Guideline: Short term use recommended (7-14 days) Non-adherence to practice guidelines as no documentation on any chart Zopiclone: Frequency of Use ii. If dosing was PRN, was there a dose per week indicated? Practice Guideline: 2 3 nights per week recommended for intermittent use Non-adherence to practice guidelines as no documentation on any chart Research Question #2c c) What factors may have influenced prescribing practices? i. Age? ii. Gender? On at Admission by Age
11 On at Admission by Gender Days Until Started by Age Male Female Avg # of Days Days Until Started by Gender On Discharge Script by Age Avg # of Days 15 1 Male Female On Discharge Script by Gender Differences in Dose by Age Male Female mg 7.5 mg 15 mg
12 Differences in Dose by Gender Male Female 3.75 mg 7.5 mg 15 mg Research Question #3 i. What percentage of patients using Zopiclone were diagnosed with insomnia? Diagnosis No Diagnosis ii. What percentage of those not using Zopiclone were diagnosed with insomnia? 2.7%.7% 97.3% 99.3% Diagnosis No Diagnosis Limitations Sample size Total n = 219 Zopiclone n = 75 Differences in charting/filing Discharge summary/discharge prescription PRN use Variable dosing Discussion Massachusetts 8 12 nursing homes, n = 145, Avg. age 83 Baseline and 6 months Neuropsych, Standardized Questionnaire, Medication Use No relationship between patterns of sed/hypnotic use and presence/absence of or change in sleep complaints Discussion Finland 9 53% in nursing homes use hypnotics Not associated with gender, memory impairment, mobility, depression, quality of sleep or sleep behavior No explanatory factor for use Discussion LTC facilities - 54% of patients had a documented sleep history (minimal) 6,7 GRH COE study on Zopiclone and Trazadone Effect of drugs on sleep time was inconsistent with dose and length of tx 12.95% on Zopiclone at that time (33%)
13 Conclusion Compliance with guidelines Prescribing practices do not meet current guidelines Dosing timelines Documentation Sleep history Diagnosis Behavioural recommendations Follow up and reassessment Recommendations Education Opportunities Review guidelines Address pressures to prescribe Address time constraints Important for both physicians and nurses Reassess practice habits in one year Thank you Pharmacy Staff Clinical Records Staff Program Director, Research Staff, Mentor References 1. Barthlen, GM. Sleep disorders: Obstructive sleep apnea syndrome, restless legs syndrome, and insomnia in geriatric patients. Geriatrics 22; 57(Nov): Ancoli-Israel, A., Cooke JR. Prevalence and comorbidity of insomnia and effect on functioning in elderly populations. JAGS 25; 53:S264-S Tjepkema M.. Health Reports 25; 17(1): Ancoli-Israel, S. in the elderly: a review for the primary care practitioner. Sleep (2); 23 Suppl 1:S Foley DJ. Et al. Sleep complaints among elderly persons: An epidemiologic study of three communities. Sleep 1995; 18: Conn DK. Madan R. Use of sleep-promoting medications in nursing home residents risks versus benefits. Drugs Aging 26; 23(4): Clapin-French E. Sleep patterns of aged persons in long-term care facilities. J Adv Nurs 1986; 11(1) Monane M. et al. The impact of sedative-hypnotic use on sleep symptoms in elderly nursing home residents. Clin Pharmacol Ther 1996; 59(1): Seppala M. et al. Subjective evaluation of sleep and the use of hypnotics in nursing homes. Aging 1993; 5(3): Towards Optimized Practice, Clinical Practice Guidelines. Management. 29 update 11. Fleming JAE. Gray J. Therapeutic Choices 4 th edition Uptodate, pharmaceutical link 13. AMA pharmaceutical link 14. Zopiclone drug monograph, sanofi-aventis Canada Inc Lexi-comp 16. Schutte-Rodin, S. et al. Clinical guideline for the evaluation and management of chronic insomnia in adults. Jnl of Clin Sleep Med 28. 4(5) Ancoli-Israel S. Ayalon, L. Diagnosis and treatment of sleep disorders in older adults. Am J Geriatr Psychiatry 26; Feb14(2):95-13 References 18. Allain, H et al. Effects on postural oscillation and memory functions of a single dose of zolpidem 5 mg, zopiclone 3.75 mg and lormetazepam 1 mg in elderly healthy subjects. A randomized, cross-over, double-blind study versus placebo. Eur J Clin Pharmacol 23; 59: Allain H, et al. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly, a comparitive review. Drugs Aging 25; 22(9): Uchiumi M. Et al. The effects of zolpidem and zopiclone on daytime sleepiness and psychomotor performance. Jpn J Neuropsychopharmacol 2; 2: Soldatos CR. Et al.tolerance and rebound insomnia with rapidly eliminated hypnotics: a meta-analysis of sleep laboratory studies. Centre for Reveiws and Dissemination. 28; Vol Silva, A. Et al. Zopiclone, but not brotizolam, impairs memory storage during sleep. Reuroscience Research 23; 47: Barbone, F. Et al. Association of road-trafffic accidents with benzodiazepine use. Lancet 1998; 352: Vermeeren, A. Et al. Differential residual effects of Zaleplon and Zopiclone on actual driving: a comparison with a low dose of alcohol. Sleep 22;25(2) Glass, J. Et al. Review: Sedative-hypnotics increase adverse effects more than they improve sleep quality in older persons with insomnia. ACP Journal Club 26; 145(1) Ahmadinejad, S. Sleeping pills, far from being the real solution. Quality assurance project for COE fellowship. 25.
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