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Morin 4 and Emerson M. Wickwire 5,6 1 Idorsia Pharmaceuticals Ltd., Hegenheimermattweg 91, 4123 Allschwil, Switzerland 2 Idorsia Pharmaceuticals US Inc., One Radnor Corporate Center, Suite 101, 100 Matsonford Rd, Radnor, PA 19087, USA 3 Cerner Enviza, 51 Valley Stream Pkwy, Malvern, PA 19355, USA 4 Department of Psychology, Cervo Brain Research Centre, Laval University, Québec City, QC G1V 0A6, Canada 5 Sleep Disorders Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA 6 Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD 21201, USA * Author to whom correspondence should be addressed. Submission received: 15 February 2023 / Revised: 15 March 2023 / Accepted: 20 March 2023 / Published: 22 March 2023 Abstract: Little is known about the associations between insomnia severity, insomnia symptoms, and key health outcomes. Using 2020 United States National Health and Wellness Survey (NHWS) data, we conducted a retrospective, cross-sectional analysis to determine the associations between insomnia severity and a number of health outcomes germane to patients (health-related quality of life (HRQoL), employers and government (workplace productivity), and healthcare payers (healthcare resource utilization (HCRU)). The Insomnia Severity Index (ISI) questionnaire was used to evaluate overall insomnia severity. HRQoL was assessed using the physical and mental component summary scores of the Short Form-36v2 (SF-36v2) questionnaire, and health utility status was measured using the Short Form-6D (SF-6D) and EuroQoL-5D (EQ-5D) questionnaires. Workplace productivity was measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. After adjusting for confounders, greater insomnia severity was significantly associated with worsened quality of life, decreased productivity, and increased HCRU in an apparent linear fashion. These findings have important implications for future research, including the need for specific assessment of insomnia symptoms and their impact on key health outcomes. 1. IntroductionInsomnia, defined as difficulty initiating and/or maintaining sleep with associated daytime consequence, is the most common sleep disorder among adults. In the United States (US), 10–15% of the population experiences chronic insomnia disorder, defined as frequency of difficulty sleeping of three or more nights per week, and duration for three or more months, with associated daytime insomnia symptoms [1,2,3]. Chronic insomnia is associated with a broad range of adverse consequences, including increased rates of poorer mental health outcomes (e.g., depression, anxiety, chronic pain, substance abuse, suicide), poorer physical health outcomes (e.g., cardiovascular disease, diabetes, stroke) and worsened health-related quality of life (HRQoL) [4]. In addition to those consequences for patients and their families, insomnia is also associated with a substantial economic burden that is borne by payers, by employers, and by society. For example, untreated insomnia is associated with increased healthcare resource utilization (HCRU) and other related costs (borne by payers), as well as increased absenteeism and diminished workplace productivity costs (i.e., presenteeism; borne

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Status, alcohol use, body mass index, total days experienced insomnia in last 12 months, any psychological comorbidities (depression, post-traumatic stress disorder, all anxiety), all pain, CCI. Table 3. Adjusted results showing association between outcomes by ISI severity group. Covariates adjusted for: age, sex, marital status, education, employment status, smoking status, alcohol use, body mass index, total days experienced insomnia in last 12 months, any psychological comorbidities (depression, post-traumatic stress disorder, all anxiety), all pain, CCI. Severe InsomniaModerate Insomnia Mild (Subthreshold) InsomniaNo Clinically Significant Insomniap Value(n = 462)(n = 2049)(n = 4180)(n = 1865)MeanSE95% CI BMeanSE95% CI BMeanSE95% CI BMeanSE95% CI B SF-6D0.580.000.57–0.59−0.150.630.000.63–0.64−0.100.680.000.67–0.68−0.050.730.000.72–0.730.00EQ-5D0.650.010.64–0.66−0.180.740.000.74–0.75−0.090.790.000.79–0.80−0.040.830.000.82–0.840.00PCS45.680.3944.92–46.44−6.7148.410.1948.04–48.77−3.9850.630.1350.38–50.87−1.7652.390.2051.99–52.790.00MCS34.040.4733.13–34.96−13.438.940.2338.49–39.38−8.5043.300.1543.00–43.60−4.1447.440.2446.96–47.920.00 RR RR RR RR Absenteeism (%)16.063.2310.83–23.815.398.710.867.18–10.572.925.020.324.43–5.691.682.980.302.44–3.641.00Presenteeism (%)37.293.1731.56–44.063.2729.521.2327.21–32.042.5919.690.5218.69–20.731.7311.400.5010.47–12.421.00Total work productivity impairment (%)40.723.4434.51–48.043.2432.231.3329.73–34.942.5721.760.5720.68–22.911.7312.550.5411.54–13.651.00Activity impairment (%)44.812.3040.51–49.562.8535.420.8933.72–37.202.2524.990.4224.18–25.831.5915.710.4214.90–16.561.00Number of HCP visits in past 6 months4.670.274.16–5.241.343.890.113.67–4.121.113.550.073.41–3.691.023.490.113.27–3.721.00Number of ER visits in past 6 months0.480.060.37–0.614.190.260.020.23–0.302.310.200.010.18–0.221.730.110.010.09–0.141.00Number of hospitalizations in past 6 months0.260.040.20–0.354.260.130.010.11–0.162.110.080.010.07–0.101.340.060.010.05–0.081.00 Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. © 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( Share and Cite MDPI and ACS Style Chalet, F.-X.; Saskin, P.; Ahuja, A.; Thompson, J.; Olopoenia, A.; Modi, K.; Morin, C.M.; Wickwire, E.M. The Associations between Insomnia Severity and Health Outcomes in the United States. J. Clin. Med. 2023, 12, 2438. AMA Style Chalet F-X, Saskin P, Ahuja A, Thompson J, Olopoenia A, Modi K, Morin CM, Wickwire EM. The Associations between Insomnia Severity and Health Outcomes in the United States. Journal of Clinical Medicine. 2023; 12(6):2438. Chicago/Turabian Style Chalet, François-Xavier, Paul Saskin, Ajay Ahuja, Jeffrey Thompson, Abisola Olopoenia, Kushal Modi, Charles M. Morin, and Emerson M. Wickwire. 2023. "The Associations between Insomnia Severity and Health Outcomes in the United States" Journal of Clinical Medicine 12, no. 6: 2438. APA Style Chalet, F.-X., Saskin, P., Ahuja, A., Thompson, J., Olopoenia, A., Modi, K., Morin, C. M., & Wickwire, E. M. (2023). The Associations between Insomnia Severity and Health Outcomes in the United States. Journal of Clinical Medicine, 12(6), 2438. Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here. Article Metrics

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By employers, but also impacting a country’s economy) [5,6,7].Daytime impairment is a core feature of insomnia disorder. Specific daytime insomnia symptoms can include fatigue, depressed mood, irritability, poor cognitive function, increased risk of accidents, and overall impaired social, vocational, educational, and behavioral functioning [4,8,9,10]. Despite the potentially debilitating impact of these daytime insomnia symptoms, insomnia research to date has primarily focused on nighttime insomnia symptoms (i.e., difficulty initiating sleep and/or difficulty maintaining sleep) when considering adverse outcomes associated with insomnia.In terms of the economic burden of insomnia, studies have examined insomnia, and assessed its severity, via diagnostic interview in prospective clinical studies, physician-assigned diagnoses in administrative claims studies, validated self-report instruments in survey research, and other approaches. [5,11,12,13] To our knowledge, there are limited analyses with data from a large number of patients that could be correlated with longer-term health and lifestyle outcomes. Given that insomnia is widely recognized as a 24-h disorder that impacts sleep quantity and quality and affects daytime functioning, data relating the severity of insomnia to outcomes would provide clinicians and researchers evidence-based guidance regarding the importance of insomnia assessment and the need for effective insomnia care.To address this important gap in knowledge, the purpose of the present study was to assess the association between insomnia severity and key health outcomes that matter to diverse stakeholders, including patients (HRQoL), payers (HCRU), and employers and government (workplace productivity). For each of these outcome domains, we hypothesized that increasing insomnia severity is associated with worse health outcomes. 2. Materials and Methods 2.1. Study Design and Data SourceThis was a retrospective, cross-sectional, observational cohort study. Data were derived from the 2020 US National Health and Wellness Survey (NHWS, Cerner Enviza, New York, NY, USA) [14,15]. The NHWS is an annual, self-administered, nationwide, internet-based survey of adults (n = ~75,000 US respondents aged ≥18 years) that collects demographic, general health, and disease-specific information and also includes measures of HRQoL, HCRU, and costs for more than 164 disease states. Respondents are recruited through a general-purpose, web-based consumer panel via channels such as opt-in e-mails, co-registration with panel partners, and e-newsletter campaigns. To ensure a representative sample of US adults, the NHWS employs a stratified random sampling procedure (including sex, race/ethnicity, and age). The data used included sociodemographic and general health characteristics, comorbidity burden, insomnia-related measures, current treatments, and EQ-5D-5L health states, among other data obtained from the survey respondents. Notably, while filling out the NHWS survey, if a person responded as having an insomnia diagnosis or as experiencing insomnia symptoms, then the questions of the Insomnia Severity Index (ISI) were posed within that survey. The NHWS protocol and survey were reviewed and determined exempt by the Pearl Institutional Review Board (Indianapolis, IN, USA; 19-KANT-204). 2.2. ParticipantsParticipants were eligible for inclusion if they were ≥18 years old, residing in the US at the time of survey completion, and self-reported as having been diagnosed and/or experiencing insomnia during the past 12 months. Respondents were excluded from this analysis if they: (1) experienced symptoms,. Insomnia Core 9.1.1. Date released: (one month ago) Download. Insomnia Core 9.1.0. Date released: (2 months ago) Download. Insomnia Core 9.0.0. Date released: (2 months ago) Download. Insomnia Core 8.6.1. Date released: (5 months ago) Download. Insomnia Core 9.0.0. Date released: (one month ago) Download. Insomnia Core 8.6.1. Date released: (5 months ago) Download. Insomnia Core

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