作者: DANIEL F. KRIPKE
DOI: 10.1111/J.1365-2869.2008.00685.X
关键词:
摘要: Fifteen epidemiologic studies have associated hypnotic drugs with excess mortality, especially cancer deaths. Until recently, insufficient controlled trials were available to demonstrate whether hypnotics actually cause any cancers. The US Food and Drug Administration (FDA) Approval History Documents accessed for zaleplon, eszopiclone ramelteon. Since zolpidem was used as a comparison drug in zaleplon trials, some data also available. Incident cancers occurring during randomized administration or placebo tabulated. Combining the four drugs, there 6190 participants given 2535 parallel. There eight mentions of incident non-melanoma skin among receiving but no comparable those (P = 0.064, one-tailed). tumors uncertain malignancy none placebo, so combining definite malignancies yielded more significant contrast 0.016). FDA files revealed that all new rodents. Three had been shown be clastogenic. Together laboratory studies, evidence signals may increase risk. Due limitations data, confirmatory research is needed.