Prescription Sleep Aids Research Articles

When Should Pharmacological Interventions for Insomnia Be Recommended?

This commentary on a case describes how social determinants of health also contribute to insomnia and then suggests how to balance risks and benefits of different strategies for managing chronic insomnia. Behaviorally induced insufficient sleep syndrome can exacerbate morning side effects of prescription sleep aids, and there are potentially serious long-term risks (eg, dementia, falls, death) associated with chronic benzodiazepine use. Before trying sleeping pills, chronic insomnia should be treated with cognitive behavioral therapy.

A large-scale survey of cannabis use for sleep: preferred products and perceived effects in comparison to over-the-counter and prescription sleep aids

Aim: Cannabis use for sleep-related problems is on the rise; however, little is known about the cannabis products people are using for sleep or the perceived effects of cannabis in comparison to more conventional sleep aids. Therefore, the aim of this study was to examine the products cannabis users prefer to use for sleep as well as their experiences with cannabis relative to more conventional sleep aids. Methods: De-identified archival data from a Strainprint® survey of 1,216 individuals who use cannabis for sleep were analyzed. Results: Participants predominantly reported smoking joints or vaping flower as their methods of administration, and seeking tetrahydrocannabinol (THC), cannabidiol (CBD), and the terpene myrcene in the cannabis they use for sleep. Only a small minority reported using cannabis in conjunction with conventional sleep aids. Comparisons of the self-reported effects of cannabis to conventional sleep aids revealed that participants reported feeling more refreshed, focused, better able to function, fewer headaches, and less nausea the morning after using cannabis for sleep than after using more conventional sleep aids or no sleep aids. However, they indicated they were more sleepy, anxious, and irritable in the mornings following the use of cannabis relative to other sleep aids. Participants were more likely to report red eyes and thirst and less likely to report nausea, anxiety, paranoia, and racing heart as side effects of cannabis relative to other sleep aids. Conclusions: Knowledge gained from this survey will provide health professionals with a better understanding of why people are using cannabis for sleep and may help guide future more controlled research.

High dose melatonin increases sleep duration during nighttime and daytime sleep episodes in older adults.

Aging is associated with changes in sleep, and improving sleep may have important consequences for the health, cognition, and quality of life of older adults. Many prescription sleep aids increase the risk of nighttime falls, have adverse effects on next-day cognition, and are associated with increased mortality. Melatonin, a hormone secreted at night, increases sleep duration in young adults but only when administered during the day when endogenous levels are low. In a month-long cross-over study, we randomized 24 healthy older (age >55, mean 64.2 ± 6.3 years) participants to receive 2 weeks of placebo and 2 weeks of either a low (0.3 mg) or high (5.0 mg) dose of melatonin 30 min before lights out. Sleep was polysomnographically recorded and was scheduled during both the biological day and night using a forced desynchrony design. Although0.3 mg melatonin had a trend towards increasing sleep efficiency (SE) overall, this was due to its effects on sleep during the biological day. In contrast, 5 mg melatonin significantly increased SE during both biological day and night, mainly by increasing the duration of Stage 2 non-rapid eye movement sleepand slightly shortening awakenings. Melatonin should be further explored as a sleep aid for older adults.

A Feasibility Study: Testing Whether a Sleep Application Providing Objective Sleep Data to Physicians Improves Patient-Physician Communication Regarding Sleep Experiences, Habits, and Behaviors.

IntroductionSleep tracker data have not been utilized routinely in sleep-related disorders and their management. Sleep-related disorders are common in primary care practice and incorporating sleep tracker data may help in improving patient care. We conducted a pilot study to assess the feasibility of a sleep program using the Fitbit Charge 2™ device and SleepLife® application. The main aim of the study was to examine whether a program using a commercially available wearable sleep tracker device providing objective sleep data would improve communication in primary care settings between patients and their providers. Secondary aims included whether patient satisfaction with care would improve as result of the program.MethodsA prospective, randomized, parallel group, observational pilot study was conducted in 20 primary care clinics in Indianapolis, IN from June 2018 to February 2019. Inclusion criteria included patients over the age of 18, have a diagnosis of insomnia identified by electronic medical record and/or a validated questionnaire, and were on a prescription sleep aid. The study was not specific to any sleep aid prescription, branded or generic, and was not designed to evaluate a drug or drug class. Each primary care clinic was randomized to either the SleepLife® intervention or the control arm. All patients were provided with a Fitbit Charge 2™ device. Only patients in the intervention arm were educated on how to use the SleepLife® application. Physicians in the intervention arm were set up with the SleepLife® portal on their computers.ResultsForty-nine physicians and 75 patients were enrolled in the study. Patients had a mean age of 57 (SD 12.8) years and 61% were female. Mean age of physicians was 47 (SD 10.6) years. Patients showed high rates of involvement in the program with 83% completing all survey questions. Physician survey completion rate was 55%. Only one physician logged into the SleepLife portal to check their patients’ sleep status. At the end of the 6-week intervention, patients’ composite general satisfaction scores with sleep health management decreased significantly in the intervention arm when compared to controls (p = 0.03). Patients’ satisfaction with communication also decreased significantly in the intervention group (p = 0.01). The sleep outcomes, which were calculated on the basis of study questionnaire answers, improved significantly in the intervention group as compared to the control group (p = 0.04). Physician communication satisfaction scores remained unchanged (p = 0.12).ConclusionsSleepLife® and its related physician portal can facilitate physician–patient communication, and it captures patient sleep outcomes including behaviors and habits. Patients were highly engaged with the program, while physicians did not demonstrate engagement. The study design and questionnaires do not specifically address the reasons behind the decreased patient satisfaction with care and communication, but it was perceived to be a result of physician non-responsiveness. Sleep quality scores on the other hand showed an improvement among SleepLife® users, suggesting that patients may have implemented good sleep practices on their own. Given that it was a feasibility study, and the sample size was small, we were not able to make major inferences regarding the difference between sleep disorder types. Additionally, we excluded patients with a history of alcohol use, substance abuse, or depression because of concerns that they may affect sleep independently. To promote the growth of technology in primary care, further research incorporating results from this study and physician engagement techniques should be included.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-02013-0.

Sleep protocol-Use of evidence-based practice (EBP) to improve patient outcomes and patient satisfaction while hospitalized.

Anecdotal observation at a 55-bed training hospital indicated decreased patient satisfaction from patients not feeling rested during hospitalization related to staggered nighttime nursing care. The main aim of this study is to implement a new culture of patient centeredness to enhance patient care and improve outcomes at a 34-bed Medical-Surgical Inpatient Unit (MSIU) within the training hospital. An evidence-based practice approach was chosen to address the aim. This included the development of a PICOT (population, intervention, comparison, outcome, and time frame) question, a systematic search of the literature, a critical appraisal of the evidence, implementation of the intervention, evaluation of outcomes, and dissemination of the results. Twenty-three articles were critically appraised, resulting in 11 keeper articles. The body of evidence reviewed demonstrated that minimizing nighttime patient interruptions through bundled care could improve patient sleep, pain perception, and patient outcomes and reduce fatigue. Bundled care was implemented in the MSIU for 1year. During this year, there was a significant reduction in hydrocodone administration, a notable reduction in prescription sleep aid administration, a 75% reduction in fall rates, a cost savings of $64,000, and a decrease in patient length of stay. Allowing patients to rest could have benefits. Rest improves outcomes, length of stay, satisfaction scores, and fall rates and reduces the need for medications. Clustering care allows patients to receive uninterrupted rest.

177 The Relationship between Language Preference and Sleep Aid Utilization among Spanish and English-speaking Latinx Adults

Abstract Introduction Studies have found positive associations between acculturation and self-reported sleep disturbances among Latinx adults, however whether acculturation-related factors influence treatment preferences for sleep disturbances remain underexplored. This study examines the relationship between language preference, an indicator of acculturation, and various types of sleep aid use among Latinx adults. Methods Using cross-sectional screener survey data from the LAtino Sleep and Health Study (N=739) of Latinx adults living in NYC, we conducted logistic regression analyses to examine the relationship between language preference and 3 types of sleep aid use (prescription, over-the-counter, and natural/herbal). Language preference was determined by whether the survey was completed in English or Spanish. Participants responded “Yes/No” to each type of sleep aid use. Primary regression models included adjustments for gender and age. Sensitivity analyses were conducted accounting for self-reported, physician-diagnosed sleep disorders. Results In unadjusted models, participants with Spanish-language preference were 2.38 (OR=2.38, 95%CI:1.30-4.36) and 1.80 (OR=1.80,95%CI:1.27-2.55) times more likely to report prescription and natural/herbal sleep aid use, respectively, compared to those with English-language preference. In primary models, language preference was not significantly associated with any type of sleep aid use. However, being below age 50 was associated with 68% and 44% decreased odds of reporting prescription and natural/herbal sleep aid use, respectively, when compared to those above age 50-79 (OR=0.32, 95%CI:0.16-0.64; OR=0.56,95%CI:0.38-0.84).Those who reported a sleep disorder were 6.35, 2.65, and 2.83 times more likely to report prescription, over-the-counter, and natural/herbal sleep aid use (OR=6.35, 95%CI:3.45-11.69; OR=2.65,95%CI:1.61-4.36; OR=2.83, 95%CI:1.85-4.37) compared to those without sleep disorder. Conclusion To our knowledge, this is the first study to examine language preference and sleep aid use in a Latinx sample. After adjusting for demographics, language was no longer significantly associated with prescription or over-the-counter sleep aid use. This change in significance may be due to differences in the age composition of the sample by language preference. Future studies in more balanced age samples should replicate these findings, and further unpack the determinants of prescription sleep aid use in Latinx adults with sleep disorders given the adverse side effects associated with prescription sleep aids. Support (if any):

Determinants of Sleep Medication Use among Participants in the National Alzheimer's Coordinating Center Uniform Data Set.

Sufficient sleep is critical for health in older adults, but prescription sleep aids are associated with numerous health risks (e.g., cognitive impairment and falls). We examine usage prevalence of two medication categories-sedative hypnotics (SH) and medications commonly used for insomnia (MCUFI)-among adults aged 45+ in the National Alzheimer's Coordinating Center data set. Analyzing the visits conducted between September 2005 and June 2018, we determine the factors associated with SH and MCUFI use, including sociodemographic, health, independence, and cognitive statuses. Usage rates were 9% for MCUFI (N = 3,279) and 4% for SH (N = 1,382). Multivariable logistic regression identified White race, higher education, younger age, depression, and sedative polypharmacy as factors associated with prescription sleep aid use. We conclude that sleep medication usage rates among older adults, higher likelihood of sedative medication polypharmacy, and higher likelihood of MCUFI use among adults with cognitive impairment are findings of concern and may warrant clinical intervention.

Use of Cannabis to Relieve Pain and Promote Sleep by Customers at an Adult Use Dispensary

ABSTRACTMedical cannabis patients consistently report using cannabis as a substitute for prescription medications; however, little is known about individuals accessing cannabis through adult-use markets. A survey at two retail stores was conducted in Colorado, United States. Between August 2016 and October 2016, store staff asked customers if they wanted to participate and, if so, provided an electronic survey link. All customers reporting medical certification were excluded. Of 1,000 adult-use only customer respondents, 65% reported taking cannabis to relieve pain and 74% reported taking cannabis to promote sleep. Among respondents taking cannabis for pain, 80% reported that it was very or extremely helpful, and most of those taking over-the-counter pain medications (82%) or opioid analgesics (88%) reported reducing or stopping use of those medications. Among respondents taking cannabis for sleep, 84% found it very or extremely helpful, and most of those taking over-the-counter (87%) or prescription sleep aids (83%) reported reducing or stopping use of those medications. De facto medical use of cannabis for symptom relief was common among adult-use dispensary customers and the majority reported that cannabis decreased their medication use. Adult use cannabis laws may broaden access to cannabis for the purpose of symptom relief.

Long-term sleep disturbance and prescription sleep aid use among cancer survivors in the United States.

Insomnia and related sleep disorders are common complaints among cancer patients, and use of prescription sleep aids can be high in the treatment setting. The prevalence of sleep disturbance and prescription sleep aid use in the community-dwelling cancer survivorship population, however, remains relatively unexplored. We aim to ascertain the extent to which a cancer diagnosis is associated with sleep disturbances and prescription sleep aid use as measured in several cross sections of individuals across multiple disease sites and time since cancer diagnosis. We used data from five cross-sectional cycles of the National Health and Nutrition Evaluation Survey (NHANES) from 2005 to 2014. We identified a total of 2371 individuals who reported a diagnosis of cancer (averaging 61years old) and 25,788 individuals who did not report a cancer diagnosis (averaging 45years old). We considered several patient-reported sleep-related outcomes. Multivariate regression analyses, as well as propensity score matching, were used to clarify the relationship between sleep disturbances, prescription sleep aid use, and cancer diagnosis, stratified by time since diagnosis and primary disease site. Reported sleep disturbance was common in cancer survivors, with approximately 34% of patients with a history of cancer reporting having ever been told they had trouble sleeping, compared to 23% of non-cancer patients in the general population with no history of cancer (p < 0.001). Propensity score matching supported a significantly higher rate of trouble sleeping among cancer survivors compared to matched controls. Compared to the general adult population without cancer, cancer survivors 11 or more years past diagnosis were more likely to report being diagnosed with trouble sleeping or a sleep disorder. Further, patients with gynecological cancers were more likely to report prescription sleep aid use, sleep disorders, and trouble sleeping compared to adults without a history of cancer. Sleeping problems are common in the cancer survivorship population, especially in patients with a long survivorship history and a history of gynecological cancers. Consideration of symptoms of insomnia and sleep disturbance may be helpful in the follow-up care of these patients.

Effects of zolpidem and zaleplon on cognitive performance after emergent morning awakenings at Tmax: a randomized placebo-controlled trial.

Prescription sleep aids are frequently used in the general population and even more frequently in spaceflight. To evaluate the risk to operational safety, a ground-based, double-blind, placebo-controlled study on the emergent awakening effects of zolpidem and zaleplon was conducted. N = 34 participants (age M = 42.1 ± 9.7; 25 males; 9 Astronauts, 7 Astronaut candidates, and 18 Flight Controllers) were investigated for three nights separated by M = 10 days. They were randomized to ingestion of one of the following at lights out: placebo, 10 mg zaleplon, and either 5 mg (N = 20) or 10 mg (N = 14) zolpidem. They were awakened abruptly by alarm at the expected PK,max (1 hr after lights out for zaleplon; 1.5 hr for placebo/zolpidem). Participants were required to turn off the alarm and perform a cognitive test battery twice, separated by a 20-30 min reading break. They then returned to sleep and were awakened to perform the same cognitive tasks at an average of 6.7 hr after drug ingestion. Relative to placebo, the effects of 10 mg zaleplon and 5 mg zolpidem on cognitive performance were minor. In contrast, 10 mg zolpidem adversely affected cognitive throughput (p < 0.001), psychomotor vigilance (p < 0.001), working memory (p < 0.01), delayed word recall (p < 0.05), and subjective sleepiness (p < 0.01) at the first emergent awakening. At terminal awakening, neither cognitive performance nor subjective sleepiness was impaired after ingestion of zaleplon or zolpidem (5 mg and 10 mg) compared with placebo. Presleep ingestion of sleep medications, especially 10 mg zolpidem, poses a risk for performance errors after emergent awakenings near the expected PK,max. Optimize Astronaut Sleep Medication Efficacy and Individual Effects (clinicaltrials.gov ID NCT03526575).

Long-Term Trends in Sleep Disturbance and Prescription Sleep Aid Use among Cancer Survivors in the United States

Long-Term Trends in Sleep Disturbance and Prescription Sleep Aid Use among Cancer Survivors in the United States

Usage transitions between natural products, over‐the‐counter, and prescription sleep aid use: A longitudinal cross‐lagged analysis

Usage transitions between natural products, over‐the‐counter, and prescription sleep aid use: A longitudinal cross‐lagged analysis

0845 INTERPRETING IN-HOME SLEEP BIOMARKERS BASED ON POLYSOMNOGRAPHY REFERENCE VALUES

Abnormal sleep patterns have been associated with increased risk for cardiovascular disease, diabetes, and neuro-degeneration. This study investigates whether references values obtained from polysomnography (PSG) can be usefully compared to sleep architecture and sleep continuity biomarkers obtained with limited-montage recordings. This retrospective analysis was conducted with frontopolar recordings made in-home with Sleep ProfilerTM (Advanced Brain Monitoring). Studies were auto-staged, expert edited, and the two-nights averaged. A normative cohort was selected from records of those who did not have insomnia, daytime sleepiness, depression or anxiety (ISI<=12, Epworth, PHQ9 and GAD7<=10), not taking prescription sleep aids or anti-depressants or diagnosed with OSA. Subjects were stratified into two groups; Young<55 years (nine males, five females, median=27 years) and Older>69 years (14 males, 15 females, median=75 years). Records from a cohort of insomnia patients were also stratified into Young (four males, 11 females, median=44 years) and Older (ten males, eight females, median=73 years) groups. Reference values were obtained from the Health Heart Study using the percentiles to estimate the age-stratified distributions. Systemic differences were recognized when the PSG distributions were significantly different from both the normative and insomnia cohorts using the Welch’s t-test (p<0.05). Frontopolar staging exhibited a systemic bias toward reduced stage N3 in the Older but not the Young group (Older: reference=18.0%, normative=5.2%, insomnia=7.3%; Young: reference=19.4%, normative=19.5%, insomnia=17.1%). A similar age-related pattern was observed in the percent time REM (Older: reference=20.7%, normative=16.9%, insomnia=17.1%). A systemic increase in stage N1 and awakenings was observed in both age groups (N1-Young: reference=4.1%, normative=6.5%, insomnia=8.3%; Older: reference=4.8%, normative=12.2%, insomnia=11.5%; Awakenings/h-Young: reference=3.3, normative=5.7, insomnia=6.5; Older: reference=3.4, normative=7.0, insomnia=7.5). The magnitude of the N1 discrepancies impacted the sleep efficiencies in the Older group (reference=81.8%, normative=74.7%, insomnia=76.2%). Discrepancies in the N3 sleep detected in the elderly may be explained by the application of different scoring rules (Rechtschaffen/Kales vs. AASM-emulated auto-scoring) applied to age and site-specific attenuation in slow wave sleep. Staging N1 and REM from frontopolar recordings likely contributed to age-specific systemic differences. All other sleep biomarker measures were equivalent. This study was supported by the NIH (P01-AG003991; K76-AG054863).

Factors contributing to poor satisfaction with sleep and healthcare seeking behavior in older adults

ObjectiveTo identify factors influencing older adults' poor satisfaction with sleep and their current healthcare seeking behaviors. DesignCross-sectional study. SettingPittsburgh Claude D. Pepper Older Americans Independence Center Community Registry. ParticipantsIndividuals aged 60 or older enrolled in the registry that completed a cross-sectional mailed survey (N = 1026). MeasurementsParticipant demographics (age, gender, marital status, race, education), overall health (self-rated health, pain, and comorbidities), and health behaviors (physical activity, smoking, drinking behaviors) were collected from the registry database. A mail survey was used to collect self-report on sleep problems and their current healthcare seeking behaviors. Simple and multiple logistic regression models were used to evaluate associations between variables. ResultsA total of 19.3% of participants reported being “dissatisfied” or “very dissatisfied” with their overall sleep quality. Participants who reported poor sleep satisfaction were more likely to be single and report poorer overall health compared to participants who were satisfied with their sleep quality. They were also more likely to report using over-the-counter (OTC) and prescription sleep medications, discuss sleep problems with a healthcare provider, and use strategies to improve their sleep (P < .05). A higher proportion of participants with trouble sleeping throughout the night reported they had discussions with a healthcare provider (47.2%), and used OTC (38.6%) or prescription (20.1%) sleep aids. ConclusionsThese results underscore the possible linkage between poor satisfaction with sleep and older adults' current healthcare seeking behaviors and self-treatment methods, particularly using OTC medications to cope with sleep problems without consulting a healthcare provider.

Estimating the cost of strategic entry delay in pharmaceuticals: The case of Ambien CR

With the Hatch-Waxman Act of 1984, the FDA included an unchallengeable exclusivity period for newly approved drugs, independent of patents. This potentially generates an incentive for firms to strategically delay the introduction of new versions (reformulations) of drugs until just before patent expiration of the original drug. This way the reformulated drug competes mainly with newly introduced generics of the original drug. If instead, the reformulated drug was to be introduced well before the original drug’s patent expires, the reformulated drug would compete only with the original drug. While the pattern of strategic delay is well documented in the literature, its effects on consumers and firms are not. Reformulations may increase utility through improved efficacy and through fewer doses per day or a more even molecule decay rate. However, as suggested in the press and literature, it is also possible that the adoption of reformulated products is mostly the result of advertising rather than product-related benefits. Using detailed prescribing and pricing data from the prescription sleep aid market, I document significant adoption of the reformulation Ambien CR and show that it is not only driven by advertising. I use these estimates to evaluate two different policies designed to induce earlier entry of Ambien CR. I find that there are large potential gains in consumer surplus and in revenue.

Estimating the Cost of Strategic Entry Delay in Pharmaceuticals: The Case of Ambien CR

With the Hatch-Waxman Act of 1984, the FDA included an unchallengeable exclusivity period for newly approved drugs, independent of patents. This potentially generates an incentive for firms to strategically delay the introduction of new versions (reformulations) of drugs until just before patent expiration of the original drug. This way the reformulated drug competes mainly with newly introduced generics of the original drug. If instead, the reformulated drug was to be introduced well before the original drug’s patent expires, the reformulated drug would compete only with the original drug. While the pattern of strategic delay is well documented in the literature, its effects on consumers and firms are not. Reformulations may increase utility through improved efficacy and through fewer doses per day or a more even molecule decay rate. However, as suggested in the press and literature, it is also possible that the adoption of reformulated products is mostly the result of advertising rather than product-related benefits. Using detailed prescribing and pricing data from the prescription sleep aid market, I document significant adoption of the reformulation Ambien CR and show that it is not only driven by advertising. I use these estimates to evaluate two different policies designed to induce earlier entry of Ambien CR. I find that there are large potential gains in consumer surplus and in revenue.

Systematic Review of Dietary Interventions Targeting Sleep Behavior.

Nearly 9 million Americans use prescription sleep aids to induce or maintain sleep; however, the long-term effects of these medications are unknown. Considering the number of individuals reporting insufficient sleep, nonpharmacologic methods for improving sleep are needed. A systematic review of published studies was conducted to determine the efficacy of nutritional intake as a modality for improving sleep behavior. Inclusion criteria for the review were interventions (both in vivo and in natura), using any quantitative design, employing a dietary intervention as the primary treatment variable, targeting sleep behavior, in nonclinical human populations age 18-50 years. A total of 21 studies (17 in vivo and 4 in natura) met the inclusion criteria and were included in the systematic review. The evidence for nutrition as treatment modality for improving sleep is mixed. Nearly half of the in vivo trials suggested a significant change in a primary sleep variable of interest. However, a majority of these trials relied on small sample sizes of healthy sleepers and manipulated nutrition in an acute fashion. Among the in natura studies, macronutrient composition appeared to have no effect. However, the small number of studies mainly recruited healthy sleepers, and most had limited control of the diet of participants.

Prevalence and Predictors of Prescription Sleep Aid Use among Individuals with DSM-5 Insomnia: The Role of Hyperarousal

Despite mounting evidence for the overuse of prescription sleep aids (PSA), reliable data on PSA use among insomniacs are unavailable. Current studies focus on trends in PSA use at the general population level, and thus do not distinguish between transient sleep disturbance and insomnia disorder. Therefore, we prospectively examined the prevalence and predictors of baseline and chronic PSA use in a well-defined sample of individuals with insomnia. We analyzed longitudinal data from an urban, community-based cohort of 649 adults (48.1 ± 11.6 y; 69.3% female) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)-based insomnia disorder. Participants completed standardized measures of sleep disturbance, daytime alertness, depression, and anxiety at baseline and follow-up 1 y later. They also reported whether and with what frequency they used PSA at both time points. Approximately 19% of the sample used PSA at baseline, the majority (69.4%) of whom continued use 1 y later. Anxiety and daytime alertness were the only independent predictors of both acute and chronic PSA use. An increase of 1 standard deviation (SD) in alertness was associated with a 33% increase in the odds of chronic PSA use (χ(2) = 4.98; odds ratio [OR] = 1.33; 95% confidence interval [CI]: 1.04-1.72; P < 0.05), and a 1-SD increase in anxiety was associated with a 41% increase (χ(2) = 6.95; OR = 1.41; 95% CI: 1.09-1.82; P < 0.05). Chronic PSA users did not report any significant improvements in sleep from baseline to follow-up relative to nonusers. Hyperarousal, as indexed by daytime alertness and anxiety, is a strong determinant of PSA use among individuals with insomnia. These findings are consistent with emerging data showing that insomnia is not just a nocturnal sleep disorder, but one characterized by 24-h arousal. Though current research targets sleep disturbance, this study highlights the role of the arousal system in pharmacological treatment seeking.

Pharmacotherapeutic Failure in a Large Cohort of Patients With Insomnia Presenting to a Sleep Medicine Center and Laboratory: Subjective Pretest Predictions and Objective Diagnoses

ObjectiveTo measure the frequency of pharmacotherapeutic failure and its association with the diagnosis of sleep-disordered breathing among patients with chronic insomnia disorder. Patients and MethodsIn a retrospective review of medical records from January 1, 2005, through December 31, 2012, we identified an inclusive, consecutive series of 1210 patients with insomnia disorder, 899 (74.3%) of whom used sleep aids either occasionally (168 [18.7%]) or regularly (731 [81.3%]). Patients presented to a community-based sleep medicine center in Albuquerque, New Mexico, with typical referral patterns: 743 (61.4%) were referred by primary care physicians, 211 (17.4%) by specialists, 117 (9.7%) by mental health professionals, and 139 (11.5%) by self-referral. Pharmacotherapeutic failure was assessed from subjective insomnia reports and a validated insomnia severity scale. Polysomnography with pressure transducer (an advanced respiratory technology not previously used in a large cohort of patients with insomnia) measured sleep-disordered breathing. Objective data yielded accuracy rates for 3 pretest screening tools used to measure risk for sleep-disordered breathing. ResultsOf the total sample of 1210 patients, all 899 (74.3%) who were taking over-the-counter or prescription sleep aids had pharmacotherapeutic failure. The 710 patients taking prescription drugs (79.0%) reported the most severe insomnia, the fewest sleep-associated breathing symptoms, and the most medical and psychiatric comorbidity. Of the 942 patients objectively tested (77.9%), 860 (91.3%) met standard criteria, on average, for a moderate to severe sleep-associated breathing disorder, yet pretest screening sensitivity for sleep-disordered breathing varied widely from 63.7% to 100%. Positive predictive values were high (about 90%) for all screens, but a tool commonly used in primary care misclassified 301 patients (32.0% false-negative results). ConclusionPharmacotherapeutic failure and sleep-disordered breathing were extremely common among treatment-seeking patients with chronic insomnia disorder. Screening techniques designed from the field of sleep medicine predicted high rates for sleep-disordered breathing, whereas a survey common to primary care yielded many false-negative results. Although the relationship between insomnia and sleep-disordered breathing remains undefined, this research raises salient clinical questions about the management of insomnia in primary care before sleep center encounters.

44 Abdominal Pain and Symptoms of Indigestion in Ulcerative Colitis in Remission Are Common and Associated With Poor Psychological Well-Being

Purpose: Sleep abnormalities are associated with serious adverse health consequences and all-cause mortality. Several studies have demonstrated associations between sleep quality and immune function and inflammation. The relationship between sleep quality and inflammatory bowel disease (IBD) activity and its impact on disease relapse has not been investigated. Methods: This is a prospective observational cohort study to assess the subjective sleep quality and its impact on disease activity and future relapse in patients with IBD. We used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality, latency, duration, efficiency, disturbances and daytime dysfunction (A global PSQI score .5 is indicative of poor sleep quality). IBD activity was measured using the Harvey Bradshaw Index (HBI, ,5= inactive) or Modified Mayo Score (MMS, 0=inactive).We also recorded depression, anxiety, BMI and current medications including OTC or prescription sleep aids. Disease relapse was defined as an increase in the disease activity requiring steroid therapy, dose escalation or additional drug during the 6 months following the initial visit. Results: 41 patients (24 CD, 17 UC) were recruited; mean age 39y ± 16; 26 (63%) females. 20/41 (49%) patients were in clinical remission, among those 5/20 (25%) had normal PSQI score and 15/20 (75%) had abnormal PSQI score at baseline. None of the 5 patients with normal PSQI and clinical remission experienced a relapse after 6 months follow up compared to 67% (10/15) of those with abnormal PSQI and clinical remission (RR=3, 95% CI 1.5 to 6.1, p=0.03). There was no difference in disease type (CD: 40% vs. 73%, p=0.18), use of steroids (20% vs. 13%, p=0.72), use of sleep aids (40% vs. 47%, p=0.79), the presence of depression or anxiety (20% vs. 20%, p=1.00) or BMI (23.6±2.9 vs. 28.3±7.3, p=0.18) between the patients in clinical remission with normal and abnormal PSQI. We noticed a significant correlation between baseline PSQI and disease activity at 6 month follow up (CD: r=0.56, p=0.0046; UC: r=0.54, p=0.024). Conclusions: This is a first prospective study of sleep abnormalities in IBD demonstrating an association between abnormal sleep quality and the likelihood of clinical relapse. Further enrollment and follow-up of these patients are ongoing.