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Varenicline is safe for people who have mental health or substance use disorder diagnoses and are stable.(4) A mental health condition is not a contraindication for using varenicline.(4) The FDA removed the black box warning for side effects on mood, behavior, or thinking from varenicline in 2016 after a massive 8000+ participant randomized controlled trial called the EAGLES trial .(4,5) The EAGLES trial, compared the relative neuropsychiatric safety risk and efficacy of varenicline and bupropion with nicotine patch and placebo in smokers with and without psychiatric disorders.(5) The main finding from this trial was, The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo.(5) This was true for people with and without psychiatric disorders.(5) These outcomes were significant enough for FDA to determine that the risk of changes to thinking, behavior, and mood were much lower than previously thought and that the consequences for any of these side effects if they did occur were generally mild, leading them to remove the black box warning.(4) You can learn the most updated information about evidence-based prescribing of tobacco-use treatment medications including varenicline from a nationally accredited tobacco use treatment specialist program

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