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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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Or had been diagnosed, with narcolepsy, sleep apnea, or other non-insomnia related sleep difficulties in the past 12 months; (2) experienced symptoms or self-reported a diagnosis of another serious medical condition (any type of cancer, chronic liver disease, cirrhosis, epilepsy, multiple sclerosis, muscular dystrophy, or Parkinson’s disease); or (3) were pregnant at the time of survey completion. 2.3. Insomnia Cohort IdentificationParticipants were identified based on responses to two standard assessment items within the NHWS: ‘Which of the following conditions have you experienced in the last 12 months?’ and ‘Which of your conditions have been diagnosed by a physician?’. Participants who reported experiencing insomnia in the previous 12 months, with or without receipt of a physician-assigned diagnosis of insomnia, completed the Insomnia Severity Index (ISI; see below). Insomnia severity was then determined based on responses to the validated ISI. 2.4. Insomnia SeverityInsomnia severity was assessed using the ISI, a well-established measure of insomnia symptoms that occur during both nighttime and daytime, albeit in broad categories [16]. The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia [16,17,18,19]. Seven items are scored from 0 (indicating little/no insomnia) to 4 (indicating problems with insomnia), and total scores range from 0 to 28. Based on this summary score, insomnia severity is categorized as follows: severe insomnia (22–28), moderate insomnia (15–21), ‘subthreshold’ (mild) insomnia (8–14), and ‘no clinically significant’ insomnia (0–7) [16]. 2.5. Outcomes 2.5.1. Health-Related Quality of LifeTo provide insight into the burden of insomnia from the patient perspective, HRQoL was assessed using the Medical Outcomes Study 36-Item Version 2 Short Form Survey Instrument (SF-36v2) (RAND, Santa Monica, CA, USA) [20]. SF-36v2 is a measure of general HRQoL that comprises 36 items that map onto 8 health domains: physical functioning, physical role limitations, bodily pain, general health, vitality, social functioning, emotional role limitations, and mental health. These individual domains are summarized in two component summary scores, the physical component summary (PCS) and mental component summary (MCS). PCS and MCS scores range from 0 to 100, each based on a population norm with a midpoint of 50, with higher scores indicating better HRQoL. Differences greater than 3.0 on the norm-based scoring algorithm were considered to be minimal clinically important differences (MCID) for scores on both scales [21]. 2.5.2. Health Utility StatusHealth utilities were assessed using two established measures: the Short Form-6 Dimensions (SF-6D) and the EuroQoL-5 Dimensions (EQ-5D-5L). SF-6D health utility index scores were derived from responses on the SF-36v2 [22]. EuroQol-5D (EQ-5D) health utility index scores were derived from the EQ-5D-5L, a self-report measure of health for clinical and economic appraisal that is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression [20]. Both SF-6D and EQ-5D health utility index scores range from 0.00 (a health state equivalent to death) to 1.00 (a health state equivalent to perfect health), with higher scores indicating better health status. Consistent with previous studies, differences greater than 0.04 and 0.07 were considered to be MCID for SF-6D and EQ-5D, respectively [22,23].

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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. Download Insomnia Core; T l charger Insomnia Core; Herunterladen Insomnia Core; Scaricare Insomnia Core; ダウンロード Insomnia Core; Descargar Insomnia Core; Baixar Insomnia

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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,