Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis.

STUDY QUESTION: What is the risk of neuropsychiatric adverse events associated with varenicline compared with placebo in randomised controlled trials? SUMMARY ANSWER: There is no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression, or death with varenicline compared with placebo. Varenicline was associated with a higher risk of sleep problems, such as insomnia and abnormal dreams. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Varenicline is a commonly prescribed and effective drug used in smoking cessation. Safety warnings have been issued regarding suicidal thoughts and depression associated with the use of varenicline, based on reports from spontaneous reporting systems. This new review found no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression, or death in varenicline users compared with placebo users in randomised controlled trials. Varenicline was associated with an increased risk of sleep disorders, insomnia, and abnormal dreams; side effects that are already well recognised and included in patient information leaflets for varenicline. [ABSTRACT FROM AUTHOR]