Varenicline, Smoking Cessation, and Neuropsychiatric Adverse Events
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OBJECTIVE: In 2009, the U.S. Food and Drug Administration issued a black box warning for varenicline regarding neuropsychiatric events. The authors used data from randomized controlled trials and from a large Department of Defense (DOD) observational study to assess the efficacy and safety of varenicline. METHOD: The authors reanalyzed data from the 17 placebo-controlled randomized controlled trials (N=8,027) of varenicline conducted by Pfizer, using complete intent-to-treat person-level longitudinal data to assess smoking abstinence and reports of suicidal thoughts and behavior, depression, aggression/agitation, and nausea and to compare effects in patients with (N=1,004) and without (N=7,023) psychiatric disorders. The authors also analyzed a large DOD data set to compare acute (30-day and 60-day) rates of neuropsychiatric adverse events in patients receiving varenicline or nicotine replacement therapy (N=35,800) and to assess reports of anxiety, mood, and psychotic symptoms and disorders, other mental disorders, and suicide attempt. RESULTS: In the randomized controlled trials, varenicline increased the risk of nausea (odds ratio=3.69, 95% CI=3.03-4.48) but not rates of suicidal events, depression, or aggression/agitation. It significantly increased the abstinence rate, by 124% compared with placebo and 22% compared with bupropion. Having a current or past psychiatric illness increased the risk of neuropsychiatric events equally in treated and placebo patients. In the DOD study, after propensity score matching, the overall rate of neuropsychiatric disorders was significantly lower for varenicline than for nicotine replacement therapy (2.28% compared with 3.16%). CONCLUSIONS: This analysis revealed no evidence that varenicline is associated with adverse neuropsychiatric events. The evidence supports the superior efficacy of varenicline relative to both placebo and bupropion, indicating considerable benefit without evidence of risk of serious neuropsychiatric adverse events, in individuals with and without a recent history of a psychiatric disorder.
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After propensity score matching in a Department of Defense observational study, the overall rate of neuropsychiatric adverse events was significantly lower for varenicline than for nicotine replacement therapy.
“After propensity score matching, the overall rate of neuropsychiatric adverse events was significantly lower for varenicline than for NRT.”
From Are smoking cessation treatments associated with suicidality risk? An overview (2016) · cites this paper as [48]
Meta-analyses of randomized controlled trials have not supported a correlation between neuropsychiatric adverse events and varenicline use.
“Meta-analyses of randomized controlled trials to date have not supported a correlation between neuropsychiatric adverse events and use of varenicline.”
From Are smoking cessation treatments associated with suicidality risk? An overview (2016) · cites this paper as [48]
In the same reanalysis, varenicline did not increase rates of suicidal events, depression, or behavior changes.
“but not the rates of suicidal events, depression, or changes in behavior.”
From Are smoking cessation treatments associated with suicidality risk? An overview (2016) · cites this paper as [48]
A current or past psychiatric illness history raised neuropsychiatric event risk equally in varenicline-treated and placebo-treated patients.
“A history of current or past psychiatric illness increased the risk of neuropsychiatric events equally in patients treated with varenicline and those receiving placebo.”
From Are smoking cessation treatments associated with suicidality risk? An overview (2016) · cites this paper as [48]
In a reanalysis of 17 placebo-controlled varenicline trials, varenicline increased the risk of nausea.
“They found that varenicline increased the risk of nausea (OR 3.69, 95% CI 3.03–4.48)”
From Are smoking cessation treatments associated with suicidality risk? An overview (2016) · cites this paper as [48]
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- Authors
- Gibbons, R. D., & Mann, J. J.
- Affiliations
- University of Chicago (US)
- Venue
- American Journal of Psychiatry
- Published
- 2013-12
- Volume
- 170
- Issue
- 12
- Pages
- 1460-1467
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- PMC
- PMC4238282
- OpenAlex
- W2101931786
- Cited by
- 142
- References
- 17
- Citations by year
- 2026: 3 · 2024: 2 · 2023: 6 · 2021: 29 · 2020: 10 · 2019: 4 · 2018: 7 · 2017: 10 · 2016: 23 · 2015: 28 · 2014: 16 · 2013: 3
- FWCI
- 16.25
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- U.S. Department of Justice
- Pfizer
- National Institute of Mental Health (MH8012201, MH-062185, P50MH062185)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Keywords
- varenicline, smoking cessation, neuropsychiatric adverse effects, black box warning, nicotine replacement therapy, bupropion, smoking abstinence, suicidal ideation, depression, aggression, nausea, mental illness, military personnel, drug safety
- MeSH terms
- Varenicline, Adult, Aggression, Mental Disorders, Benzazepines, Depression, Female, Humans, Male, Nausea, Psychomotor Agitation, Quinoxalines, Risk Factors, Suicide, Attempted, Randomized Controlled Trials as Topic, Smoking Cessation, Bupropion, Treatment Outcome, Akathisia, Drug-Induced, Suicidal Ideation, Tobacco Use Cessation Devices, Observational Studies as Topic
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