title: Association of statin use with sleep disturbances: data mining of a spontaneous reporting database and a prescription database.
abstract: BACKGROUND
  Particular interest has been generated regarding the possible influence of statin use on sleep quality. However, no conclusive evidence exists that a particular statin is more likely to be associated with sleep disturbances versus others. It remains uncertain whether different statins produce different risks for sleep disturbance.
  
  
  OBJECTIVE
  To examine the association between statin use and the risk of sleep disturbances, we conducted data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and a large organized database of prescriptions constructed by a database vendor (Japan Medical Information Research Institute, Inc. Japan).
  
  
  METHODS
  Relevant reports in the FAERS were identified and analyzed. Data from the first quarter of 2004 through the end of 2012 [corrected] were included in this study.The reporting odds ratio (ROR) was used to detect spontaneous report signals, calculated using the case/non-case method. For the ROR, a signal was detected if the lower limit of 95 % two-sided confidence interval (95 % CI) was >1. Additionally, signal detection using the IC was conducted using the IC025 metric, a lower limit of the 95 % CI of the IC, where a signal is detected if the IC025 value exceeds 0. In addition, symmetry analysis was used to identify the risk of insomnia after using statins over the period of January 2006 to August 2013.
  
  
  RESULTS
  In the analyses of the FAERS database, significant signals for sleep disturbances including disturbances in initiating and maintaining sleep, sleep disorders NEC, sleeping disorders due to a general medical condition, and parasomnias were found. In the prescription sequence symmetry analysis, a significant association between statin use and hypnotic drug use was found, with adjusted sequence ratios of 1.14 (1.03-1.26), 1.20 (1.11-1.29), and 1.18 (1.11-1.25) at intervals of 91, 182, and 365 days, respectively.
  
  
  CONCLUSIONS
  Multi-methodological approaches using different algorithms and databases strongly suggest that statin use is associated with an increased risk for sleep disturbances including insomnia.
authors.affiliation: Division of Clinical Drug Informatics, School of Pharmacy, Kinki University, 3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan, takada@phar.kindai.ac.jp.
authors.forename: Mitsutaka
authors.initials: M
authors.lastname: Takada
authors.forename: Mai
authors.initials: M
authors.lastname: Fujimoto
authors.forename: Kohei
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Masashi
authors.initials: M
authors.lastname: Takamoto
authors.forename: Kouichi
authors.initials: K
authors.lastname: Hosomi
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D057225:Data Mining / Q000379:methods; D016208:Databases, Factual; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D055656:Prescriptions; D012306:Risk; D012890:Sleep / Q000187:drug effects*; D012893:Sleep Wake Disorders / Q000139:chemically induced*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
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