Long Meng1, Jing Huang2, Qin He3, Yibei Zhao4, Wenlong Zhao5, Juntao Tan6, Shusen Sun7,8, Junqing Yang4. 1. Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University; Key Laboratory of Biochemistry and Molecular Pharmacology, Department of Pharmacology, Chongqing Medical University, Chongqing, China. 2. Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 3. Department of Hepatobiliary Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 4. Key Laboratory of Biochemistry and Molecular Pharmacology, Department of Pharmacology, Chongqing Medical University, Chongqing, China. 5. College of Medical Informatics, Chongqing Medical University; Medical Data Science Academy, Chongqing Medical University, Chongqing, China. 6. Medical Records and Statistics Room, People's Hospital of Chongqing Banan District, Chongqing, China. 7. Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western New England University, Springfield, MA. 8. Department of Pharmacy, Xiangya Hospital Central South University, Changsha, Hunan, China.
Abstract
STUDY OBJECTIVES: There is no consensus information on infections associated with nonbenzodiazepines. Knowledge about infections related to newly marketed hypnotics (orexin receptor antagonists and melatonin receptor agonists) is scarce. The study aimed to detect infection signals for nonbenzodiazepines, orexin receptor antagonists, and melatonin receptor agonists by analyzing data from the U.S. Food & Drug Administration adverse event reporting system. METHODS: A disproportionality analysis was performed to quantitatively detect infection signals for hypnotics by calculating the reporting odds ratio and the 95% confidence interval. Data registered in the U.S. Food & Drug Administration adverse event reporting system from 2010-2020 were retrieved. RESULTS: A total of 3,092 patients with infection were extracted for the 3 classes of hypnotic drugs. Nonbenzodiazepines were associated with a higher disproportionality of infections (reporting odds ratio: 1.10; 95% confidence interval, 1.06-1.14). The association of infections was not present for melatonin receptor agonists (reporting odds ratio: 0.86; 95% confidence interval, 0.74-1.00) and orexin receptor antagonists (reporting odds ratio: 0.19; 95% confidence interval, 0.15-0.25). Significant reporting associations were identified for nonbenzodiazepines concerning the categories of bone and joint infections, dental and oral soft tissue infections, upper respiratory tract infections, and urinary tract infections. CONCLUSIONS: Nonbenzodiazepines had a positive signal for infections, while orexin receptor antagonists and melatonin receptor agonists had a negative signal. More research needs to be conducted to confirm this relationship. CITATION: Meng L, Huang J, He Q, et al. Hypnotics and infections: disproportionality analysis of the U.S. Food & Drug Administration adverse event reporting system database. J Clin Sleep Med. 2022;18(9):2229-2235.
STUDY OBJECTIVES: There is no consensus information on infections associated with nonbenzodiazepines. Knowledge about infections related to newly marketed hypnotics (orexin receptor antagonists and melatonin receptor agonists) is scarce. The study aimed to detect infection signals for nonbenzodiazepines, orexin receptor antagonists, and melatonin receptor agonists by analyzing data from the U.S. Food & Drug Administration adverse event reporting system. METHODS: A disproportionality analysis was performed to quantitatively detect infection signals for hypnotics by calculating the reporting odds ratio and the 95% confidence interval. Data registered in the U.S. Food & Drug Administration adverse event reporting system from 2010-2020 were retrieved. RESULTS: A total of 3,092 patients with infection were extracted for the 3 classes of hypnotic drugs. Nonbenzodiazepines were associated with a higher disproportionality of infections (reporting odds ratio: 1.10; 95% confidence interval, 1.06-1.14). The association of infections was not present for melatonin receptor agonists (reporting odds ratio: 0.86; 95% confidence interval, 0.74-1.00) and orexin receptor antagonists (reporting odds ratio: 0.19; 95% confidence interval, 0.15-0.25). Significant reporting associations were identified for nonbenzodiazepines concerning the categories of bone and joint infections, dental and oral soft tissue infections, upper respiratory tract infections, and urinary tract infections. CONCLUSIONS: Nonbenzodiazepines had a positive signal for infections, while orexin receptor antagonists and melatonin receptor agonists had a negative signal. More research needs to be conducted to confirm this relationship. CITATION: Meng L, Huang J, He Q, et al. Hypnotics and infections: disproportionality analysis of the U.S. Food & Drug Administration adverse event reporting system database. J Clin Sleep Med. 2022;18(9):2229-2235.
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