Sleep Medication in Older Adults: Identifying the Need for Support by a Community Pharmacist

Many older adults take benzodiazepines and sedative-hypnotics for the treatment of sleep disorders. With a view to considering the possible discontinuation of hypnotics, the objectives of the present study were to describe bedtime habits and sleep patterns in older adults and to identify the sleep medications taken. An expert group developed a structured interview guide for assessing the patients’ bedtime habits, sleep patterns, and medications. During an internship in a community pharmacy, 103 sixth-year pharmacy students conducted around 10 interviews each with older adults (aged 65 or over) complaining of sleep disorders and taking at least one of the following medications: benzodiazepines, benzodiazepine derivatives (“Z-drugs”), antihistamines, and melatonin. A prospective, observational study was carried out from 4 January to 30 June 2016. The pharmacy students performed 960 interviews (with 330 men and 630 women; mean ± standard deviation age: 75.1 ± 8.8). The most commonly taken hypnotics were the Z-drugs zolpidem (n = 465, 48%) and zopiclone (n = 259, 27%). The vast majority of patients (n = 768, 80%) had only ever taken a single hypnotic medication. The median [interquartile range] prescription duration was 120 (48–180) months. About 75% (n = 696) of the patients had at least 1 poor sleep habit, and over 41% (n = 374) had 2 or more poor sleep habits. A total of 742 of the patients (77%) reported getting up at night—mainly due to nycturia (n = 481, 51%). Further, 330 of the patients (35%) stated that they were keen to discontinue their medication, of which 96 (29%) authorized the pharmacist to contact their family physician and discuss discontinuation. In France, pharmacy students and supervising community pharmacists can identify problems related to sleep disorders by asking simple questions about the patient’s sleep patterns. Together with family physicians, community pharmacists can encourage patients to discuss their hypnotic medications.

Hypnotic Medication Use

Hypnotic medications are widely prescribed for the treatment of insomnia, and, either due to patient preference or medical necessity, some patients must discontinue use of hypnotics after using these medications for long periods of time. Helping patients to discontinue use of hypnotics can be clinically challenging. Hypnotic taper interventions as well as hypnotic taper interventions combined with cognitive behavior therapy for insomnia (CBT-I) are generally useful in helping patients discontinue use without significant disruption to sleep. Interventions that include CBT-I seem to have greater long-term benefits as patients experience improvements in sleep that are long-lasting and are better able to abstain from hypnotic use in the future. Additional research to incorporate motivational enhancement strategies and better understand the optimal timing and structure of hypnotic medication tapering interventions with CBT-I are needed.

350 Opioid Use and Abuse are Associated with Use of Sedative Hypnotic Medications

Introduction The Department of Health and Human Services recently reported that 10.3 million people misused opioid drugs in 2018. Recent research attributed 21% of the deaths from opioid overdose to benzodiazepines. The overdose data and clinical experience show that opioid misusers commonly complain of insomnia and use hypnotic medications to self-medicate their sleep disturbance. At the same time, it remains unclear from a scientific perspective whether those who use/abuse opioids are more likely to use drugs in the sedative-hypnotic medication category. Consequently, the present study explores the relationship between comorbid use of opioids and sedative-hypnotic medications. Methods We extracted data from the 2015–2018 waves of the National Survey on Drug Use and Health (N=171,766). The primary outcome was the use of sedative-hypnotic medications, either in the z-class (zaleplon, zolpidem, eszopiclone) or sedating benzodiazepines (temazepam, flurazepam, triazolam). The primary exposures were prescription use of an opioid or abuse of an opioid (i.e., use of an illegal opioid such as heroin or misuse of a prescription opioid). Covariates included age, sex, race, income, education, and predicted mental illness category (none, mild, moderate, severe). Exposures were balanced on covariates using inverse probability of treatment weighting. Sequential binomial logistic regression estimated the association between opioid use/abuse and sedative-hypnotic use after adjusting for covariates. Results Opioid use and abuse varied by age, sex, race, education, and income (all p < 0.001). When adjusted for age, sex, and race (Model 1), sedative benzodiazepine use was more common among opioid users (OR 4.4 [4.04–4.79] and opioid abusers (OR 11.9 [9.72–14.5]). The use of z-class drugs was also more prevalent in opioid users (OR 3.69 [3.48–3.89]) and abusers (OR 7.74 [6.97–8.60]). Further adjusting for income and education (Model 2) and mental illness category (Model 3) attenuated but did not eliminate these associations. Conclusion Individuals who use or abuse opioids are significantly more likely to receive a sedative-hypnotic medication, a finding that is of concern and one that also suggests that sleep disturbance is common in this population. Further research is needed to determine the underlying nature and prevalence of sleep continuity disturbances in this population. Support (if any) VA grant IK2CX000855 and I01 CX001957 (S.C.).

744 Correlates to improvement in sleep in acute mania

Introduction Sleep disruption and reduced sleep duration are potential triggers and also core symptoms of a manic episode. Our understanding of how sleep duration changes during the course of a manic episode and its potential association with symptom improvement is limited. We examined the natural course of sleep duration and its association with time to discharge and other clinical and demographic factors in patients with mania. Methods This was a retrospective study conducted in patients admitted to an acute care psychiatric unit with a manic episode. Sleep duration was determined based on observer report as logged by nursing staff. Sleep duration at admission and discharge were determined by averaging the total sleep time on day 2/3 of hospitalization and day 3/2 preceding discharge date. We obtained data on possible confounders including antipsychotic (chlorpromazine equivalents), benzodiazepine (diazepam equivalents) and other hypnotic medication doses administered at admission and discharge. We examined the associations between the change in sleep duration from admission to discharge with length of hospitalization and other clinical and demographic characteristics. Results The sample consisted of 35 patients (54.3% male) aged 32 ± 9.96 years with an average length of hospitalization of 20.63 ± 18.62 days. The mean sleep duration on admission was 6.23 ± 1.77 hours and was 7.45 ± 1.49 hours on discharge, with a mean change of 1.23 ± 1.93 hours. The change in sleep duration was positively correlated with length of hospitalization (r=0.42; p=0.01). Other clinical factors including benzodiazepine or antipsychotic dose on admission, age, sex, and use of mood stabilizers were not correlated with the change in sleep duration. Conclusion There was a substantial improvement in the total sleep duration in patients with mania over the course of hospitalization. Overall, the change in sleep duration was only correlated to the length of stay and did not appear to be impacted by other clinical and demographic characteristics. Support (if any):

High and low ambient temperature at night and the prescription of hypnotics

Study objectives This study investigated the association between ambient nighttime temperature and sleep problems assessed by the prescription dose of sleeping pills in South Korean adults. Methods We used the 2002-2015 National Health Insurance Service-National Sample Cohort. A total of 711,079 adults who were 20 years old or older were included, wherein 42,858 adults (approximately 6%) had been prescribed hypnotic medications including zolpidem (N05CF02) and triazolam (N05CD05). Ambient temperature data was calculated as the mean highest temperature of nighttime (23:00-07:00) for every month from January to December. We combined the drug-prescribed date with the administrative districts-level daily nighttime temperature between 2002 and 2015. Results We found that a non-linear, U-shaped relationship between nighttime temperature and hypnotic medication prescription. With an increase per 1°C temperature or an increase in a square per 1°C, the prescription dose of sleeping pills was significantly increased (both p <0.05). At each 5°C nighttime temperature, subjects belonging to low (≤0°C and 0 – 5°C) or high (20 – 25°C and ≥25°C) temperature categories had significantly higher doses of sleeping pills than those at the reference temperature (10 – 15°C). Changes in nighttime temperature had a significant non-linear effect on the prescribed dosage of hypnotic medications for both adults (p <.0001) and the elderly (p = 0.0006). Conclusion We found that either a high or low nighttime temperature was significantly associated with a high daily dose of hypnotic medications in the Korean population.

Impact of Pharmacist-Led Cognitive Behavioural Therapy for Chronic Insomnia

Background: Chronic insomnia is a common medical condition that negatively impacts quality of life and daytime function. Access to the first-line treatment for insomnia, cognitive behavioural therapy (CBT-i), is limited. Pharmacists are well positioned to provide this service, but evidence regarding pharmacist delivered CBT-i is sparse. The aim of this study was to evaluate the effectiveness of CBT-i delivered by pharmacists practicing in an outpatient clinic setting. Methods: This study was a retrospective chart audit of adult patients with chronic insomnia who received CBT-i from a pharmacist at one of two outpatient clinics in Canada. The primary endpoints were the differences between patient self-reported sleep diary parameters and utilization of hypnotic medications before and after CBT-i was delivered. The differences in patient reported sleep parameters were compared using Wilcoxon Signed Rank test and paired samples t-test and changes in hypnotic utilization was compared using McNemar Chi-square test. Results: 183 patients were referred for CBT-i and attended an initial appointment with a pharmacist. Of these, 105 did not receive the CBT-i. This resulted in 78 patients who met the inclusion criteria. Changes in sleep diary parameters were all statistically significantly improved after patients received CBT-i, except for total sleep time. Hypnotic medication use was also reduced. At baseline, 71.8% (n=56/78) of patients were taking one or more hypnotic medications compared to 52.6% (n=41/78) after CBT-i (p=0.0003). Discussion: The results of this study provide preliminary evidence that pharmacists working in an outpatient clinic setting may be able to effectively deliver CBT-i for patients with chronic insomnia. The external validity of these results is limited by the observational study design and the inclusion of pharmacists practicing in outpatient clinics, which is not the setting where most pharmacists currently practice. Conclusion: This observational study found improvements in sleep quality and efficiency, as well as, a reduction in hypnotic medication use, in patients who received CBT-i from pharmacists practicing in an outpatient clinic setting. Future randomized, controlled trials should evaluate the impact of CBT-i in a larger sample of patients, provided by pharmacists practicing in both outpatient clinics and community pharmacies. Original Research

0497 Rebound Insomnia During Discontinuation of Chronic Hypnotic Use

Introduction Rebound insomnia refers to worsened sleep relative to baseline on 1-2 nights after discontinuation of active hypnotic medication. Rebound is typically assessed using a placebo substitution. We assessed rebound in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication (i.e., no-pill) after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=31, 26 females), aged 26-61 yrs, with a polysomnographic sleep efficiency of ≤85%, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). On baseline and the14 discontinuation nights, sleep was recorded and scored by actigraphy for sleep efficiency (SE), sleep latency (LAT) and wake after sleep onset (WASO). Results Relative to the baseline night, on the first discontinuation night there was no difference in SE, LAT, and WASO. Fifteen subjects stopped taking study medication when told to discontinue and 16 subjects took study medication on one night or more. While not differing on baseline or night 1, on night 14 the last study night the medication users had a lower SE (75.9 vs 87.7 %, p<.0.004) and a longer LAT (61.5 vs 14.5 min, p<0.05). Conclusion Difficulty discontinuing hypnotic use is not specifically related to rebound insomnia. We reported in a companion abstract those with insomnia and hyperarousal, defined by MSLT, are those with difficulty discontinuing hypnotic use and as shown here slept poorly on the last study night. Support NIDA, grant#: R01DA038177 awarded to Dr. Roehrs

Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial

IntroductionA considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.Methods and analysisThis is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.Ethics and disseminationEthical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.Trial registration numberKCT0003235.