Varenicline Safe and Effective in Smokers with Depression

Summary and Comment |
September 16, 2013

Varenicline Safe and Effective in Smokers with Depression

  1. Peter Roy-Byrne, MD

Compared with placebo, varenicline doubles quit rates in smokers with treated depression, without exacerbation of depressive symptoms or suicidality.

  1. Peter Roy-Byrne, MD

Depression is associated with elevated rates of smoking, new nicotine dependence, and relapse after smoking cessation. Varenicline has produced greater quit rates than bupropion in some studies of nondepressed smokers, but reports of greater depression and suicidal ideation with this medication have limited its use with depressed patients. In a 12-month, randomized, controlled, manufacturer-funded study, researchers examined the efficacy and safety of 12 weeks of varenicline (0.5–1.0 mg twice daily) and placebo in 525 smokers with recent unipolar depression. Mean depression scores were low, but some patients remained symptomatic; overall, more than 70% of participants were receiving antidepressants.

The rate of smoking cessation was double with varenicline than with placebo (3 months, 36% vs. 16%; 6 months, 25% vs. 12%; 12 months, 20% vs. 10%). Depression and anxiety scores gradually improved over time, with no difference between varenicline and placebo. Rates of suicidal ideation and across the spectrum of adverse events were similar in the two groups.


This study shows that varenicline is safe and effective for smokers with stably treated depression who are interested in quitting. Depressed patients have particular difficulty with withdrawal effects, often prompting a return to smoking. For these patients, therefore, as the authors note, the ability of varenicline to block nicotine's rewarding effects even as it acts as a partial agonist may be particularly helpful, although it remains unclear whether varenicline's previously observed superiority over some other treatments extends to this population. Still, its tolerability, safety, and efficacy suggest its viability as a treatment option.

Editor Disclosures at Time of Publication

  • Disclosures for Peter Roy-Byrne, MD at time of publication Equity Valant Medical Solutions Grant / research support NIH-NIDA; NIH-NIMH Editorial boards Depression and Anxiety; UpToDate Leadership positions in professional societies Anxiety Disorders Association of America (Ex-Officio Board Member); Washington State Psychiatric Society (Treasurer)


Reader Comments (1)

Edward Zevin, GSG, HSD, BA, DO, DABNP Physician, Other, VA

Stellar Work!!

Your Comment

(will not be published)

Filtered HTML

  • Allowed HTML tags: <a> <em> <strong> <cite> <blockquote> <code> <ul> <ol> <li> <dl> <dt> <dd>
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Do you have any conflict of interest to disclose?
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

* Required

Reader comments are intended to encourage lively discussion of clinical topics with your peers in the medical community. We ask that you keep your remarks to a reasonable length, and we reserve the right to withhold publication of remarks that do not meet this standard.

PRIVACY: We will not use your email address, submitted for a comment, for any other purpose nor sell, rent, or share your e-mail address with any third parties. Please see our Privacy Policy.