Department of Psychiatry, University of Arizona College of Medicine, Tucson, AZ, USA.
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, Allschwil, 4123, Switzerland.
BMC Public Health. 2023 Aug 3;23(1):1481. doi: 10.1186/s12889-023-16329-9.
Insomnia disorder is a highly prevalent, significant public health concern associated with substantial and growing health burden. There are limited real-world data assessing the burden of insomnia disorder on daytime functioning and its association with comorbidities. The objective of this study was to leverage large-scale, real-world data to assess the burden of untreated insomnia disorder in terms of daytime impairment and clinical outcomes.
This United States medical claims database study compares patients diagnosed with insomnia disorder but not receiving treatment ('untreated insomnia' cohort) to patients without an insomnia disorder diagnosis and without treatment ('non-insomnia' cohort). International Classification of Disease, Tenth Revision codes were used as a proxy to represent the three symptom domains (Sleepiness, Alert/Cognition, Mood) of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a newly developed and validated tool used in clinical studies to assess daytime functioning in insomnia disorder. Chronic Fatigue (R53.83) and Other Fatigue (R53.83), Somnolence (R40.0) and Disorientation (R41.0) were selected as categories representing one or more IDSIQ domains. Clinical outcomes included cardiovascular events, psychiatric disorders, cognitive impairment and metabolic disorders.
Approximately 1 million patients were included (untreated insomnia: n = 139,959; non-insomnia: n = 836,975). Compared with the 'non-insomnia' cohort, the 'untreated insomnia' cohort was more likely to experience daytime impairments, with mean differences in occurrences per 100 patient-years for: (a) fatigue, at 27.35 (95% confidence interval [CI] 26.81, 27.77, p < 0.01); (b) dizziness, at 4.66 (95% CI 4.40, 4.90, p < 0.01); (c) somnolence, at 4.18 (95% CI 3.94, 4.43, p < 0.01); and (d) disorientation, at 0.92 (95% CI 0.77, 1.06, p < 0.01). During the 1-year look-back period, patients in the 'untreated insomnia' cohort were also more likely to have been diagnosed with arterial hypertension (40.9% vs. 26.3%), psychiatric comorbidities (40.1% vs. 13.2%), anxiety (29.2% vs. 8.5%), depression (26.1% vs. 8.1%) or obesity (21.3% vs. 11.1%) compared with those in the 'non-insomnia' cohort.
This large-scale study confirms the substantial burden of insomnia disorder on patients in a real-world setting, with significant daytime impairment and numerous comorbidities. This reinforces the need for timely insomnia disorder diagnosis and treatments that improve both sleep, as well as daytime functioning.
失眠障碍是一种高发且严重的公共健康问题，与大量且不断增加的健康负担有关。目前，评估失眠障碍对日间功能的负担及其与合并症的关系的真实世界数据有限。本研究旨在利用大规模的真实世界数据，评估未治疗的失眠障碍在日间功能障碍和临床结局方面的负担。
本项美国医疗索赔数据库研究比较了诊断为失眠障碍但未接受治疗的患者（“未治疗失眠”队列）与无失眠障碍诊断且未接受治疗的患者（“非失眠”队列）。使用国际疾病分类，第十次修订版代码作为代表失眠日间症状和影响问卷（IDSIQ）三个症状域（困倦、警觉/认知、情绪）的替代物，这是一种新开发和验证的工具，用于评估失眠障碍中的日间功能。慢性疲劳（R53.83）和其他疲劳（R53.83）、嗜睡（R40.0）和定向障碍（R41.0）被选为代表一个或多个 IDSIQ 域的类别。临床结局包括心血管事件、精神障碍、认知障碍和代谢紊乱。
大约有 100 万名患者被纳入研究（未治疗失眠：n=139959；非失眠：n=836975）。与“非失眠”队列相比，“未治疗失眠”队列更有可能出现日间功能障碍，100 名患者每年发生的平均差异为：（a）疲劳，为 27.35（95%置信区间[CI] 26.81，27.77，p<0.01）；（b）头晕，为 4.66（95% CI 4.40，4.90，p<0.01）；（c）嗜睡，为 4.18（95% CI 3.94，4.43，p<0.01）；和（d）定向障碍，为 0.92（95% CI 0.77，1.06，p<0.01）。在为期 1 年的回顾期内，“未治疗失眠”队列的患者也更有可能被诊断为高血压（40.9% vs. 26.3%）、合并精神疾病（40.1% vs. 13.2%）、焦虑（29.2% vs. 8.5%）、抑郁（26.1% vs. 8.1%）或肥胖（21.3% vs. 11.1%），而非失眠队列。
这项大规模研究证实了失眠障碍在现实环境中对患者的负担很大，存在明显的日间功能障碍和许多合并症。这再次强调了及时诊断和治疗失眠障碍的必要性，以改善睡眠和日间功能。
