Over-the-counter and prescription sleep medication and incident stroke: the REasons for Geographic and Racial Differences in Stroke study

J Stroke Cerebrovasc Dis. 2014 Sep;23(8):2110-2116. doi: 10.1016/j.jstrokecerebrovasdis.2014.03.025. Epub 2014 Aug 10.


Background: Preliminary evidence suggests sleep medications are associated with risk of vascular events; however, the long-term vascular consequences are understudied. This study investigated the relation between sleep medication use and incident stroke.

Methods: Within the REasons for Geographic And Racial Differences in Stroke study, 21,678 black participants and white participants (≥45 years) with no history of stroke were studied. Participants were recruited from 2003 to 2007. From 2008 to 2010, participants self reported their prescription and over-the-counter sleep medication use over the past month. Suspected stroke events were identified by telephone contact at 6-month intervals and associated medical records were retrieved and physician-adjudicated. Proportional hazards analysis was used to estimate hazard ratios for incident stroke associated with sleep medication use (0, 1-14, and 15+ days per month) controlling for sociodemographics, stroke risk factors, mental health symptoms, and sleep apnea risk.

Results: At the sleep assessment, 9.6% of the sample used prescription sleep medication and 11.1% used over-the-counter sleep aids. Over an average follow-up of 3.3 ± 1.0 years, 297 stroke events occurred. Over-the-counter sleep medication use was associated with increased risk of incident stroke in a frequency-response relationship (P = .014), with a 46% increased risk for 1-14 days of use per month (hazards ratio [HR] = 1.46; 95% confidence interval [CI], .99-2.15) and a 65% increased risk for 15+ days (HR = 1.65; 95% CI, .96-2.85). There was no significant association with prescription sleep medications (P = .80).

Conclusions: Over-the-counter sleep medication use may independently increase the risk of stroke beyond other risk factors in middle-aged to older individuals with no history of stroke.

Keywords: REGARDS Study; Sleep medication; over-the-counter; sleeping pills; stroke.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • African Continental Ancestry Group
  • Aged
  • Drug Utilization / statistics & numerical data*
  • European Continental Ancestry Group
  • Female
  • Follow-Up Studies
  • Humans
  • Hypnotics and Sedatives / administration & dosage
  • Hypnotics and Sedatives / adverse effects*
  • Incidence
  • Male
  • Middle Aged
  • Nonprescription Drugs / administration & dosage
  • Nonprescription Drugs / adverse effects*
  • Predictive Value of Tests
  • Prescription Drugs / administration & dosage
  • Prescription Drugs / adverse effects*
  • Risk Assessment
  • Risk Factors
  • Self Report
  • Sleep / drug effects
  • Stroke / epidemiology*
  • Stroke / etiology*
  • Time Factors


  • Hypnotics and Sedatives
  • Nonprescription Drugs
  • Prescription Drugs