López Arteaga MT, Amo C, Sánchez Morla EM, Sánchez Román M. Induced psychosis after withdrawal of varenicline: a case report.

Objective: Varenicline has been associated with psychiatric side effects, and cases with psychotic symptoms during treatment have been reported, few of them after the withdrawal. We describe a case with no current or previous medical or psychiatric history.

Method: A single case report.

Results: The patient without previous psychiatric pathology, following the withdrawal of treatment with varenicline, experiences delirium and behavioural disturbances. There was a remission of symptoms after 3 weeks of treatment with risperidone.

Conclusion: Discontinuation of treatment with varenicline due to poor tolerance for side effects (nausea and insomnia) could trigger psychotic symptoms in subjects with no personal or family psychiatric history.

Background: The mechanism of action of varenicline as a partial agonist may make it useful for cigarette reduction as smokers experience reduced craving and withdrawal at the same time their cigarettes provide reduced reinforcement value.

Case Description: The current case report describes a 51-year-old African American woman using varenicline to reduce her cigarette use. After making a substantial reduction in cigarettes per day (from 25 to 8), the patient unexpectedly began smoking considerably more (from 8 to 20) after 11 days treatment with varenicline.

Conclusions: The temporary increase in smoking while taking varenicline was likely the result of an ‘extinction burst’ where the extinction of a reward (e.g., nicotine's rewarding effects after smoking a cigarette) was temporarily associated with an increase in the behaviour usually associated with the reward (e.g., smoking a cigarette). Once explaining to her that no amount of cigarettes would overcome the feeling of reduced reward she likely felt while taking varenicline, she was able to reduce her smoking again.

Since its launch as a smoking cessation aid, varenicline use has been linked to a number of serious adverse events, notably the exacerbation of pre-existing psychiatric illness, depressed mood and suicidal ideation. Regulators’ fears have been somewhat allayed by varenicline's status as a prescription only medication. The purpose of this study was to examine the care provided by physicians – or general practitioners – and pharmacists to varenicline users under real-world conditions. Participants were 141 patients who had filled a prescription for varenicline at a participating pharmacy within the previous six-months. Identified patients were mailed a survey to complete that included items on interactions with their physician and pharmacy staff, and knowledge of treatment side-effects. Most participants reported that their physician encouraged them to set a quit date (82.5%) and provided additional cessation materials (57.2%). While most (79.0%) physicians discussed whether varenicline was appropriate for the patient, fewer asked about psychiatric illness (40.1%), or asked to be informed about mood or behaviour change during treatment (48.1%). Participants (78.4%) reported that their physician had discussed a follow-up consultation, but only 59.4% of patients who had finished treatment at the time of the survey reported having one. Most reported discussing potential drug side-effects with their physician (71.0%) and or pharmacist (52.9%); when probed, knowledge was variable. These results suggest that many patients do not receive the level of support that physicians and pharmacists are assumed to provide.

Purpose: To determine whether the combination of bupropion SR and varenicline offers improved smoking cessation outcomes compared to varenicline monotherapy or to combination of bupro-pion SR and nicotine patch. Methods: This retrospective chart review included 489 volunteer enrolees in a Veterans Affairs (VA) tobacco cessation clinic who received one of the three treatments upon clinic enrolment. The study endpoints were smoking cessation and clinic completion rates, changes in the number of cigarettes smoked, carbon monoxide (CO) levels, urges to smoke, self-confidence to quit and medication-attributed adverse effects. Results: The relative smoking cessation rates were 33%, 32%, and 40% for bupropion SR and nicotine patch, bupropion SR and varenicline, and varenicline groups, respectively. The 0.21 p value established that no significant cessation rate differences existed between any of the groups. Varenicline alone or in combination was as well tolerated as the combination of bupropion SR and nicotine patch. Conclusions: The combination of bupropion SR and varenicline did not demonstrate any smoking cessation advantage over varenicline monotherapy or the combination of bupropion SR and nicotine patch and therefore do not support the use of bupro-pion SR and varenicline over varenicline monotherapy.

We conducted a sensitivity analysis under four scenarios using data from three Asian studies conducted with low dropout rates to evaluate the efficacy of varenicline in smoking cessation within a scenario where dropouts from the study are dealt with in a manner as unfavourable as possible to varenicline. Pooled odds ratio of continuous abstinence at week 24 was 1.55 (95% confidence interval: 1.03–2.35, random-effect model) under the scenario where dropouts from the varenicline group were dealt with as smokers and those from the placebo group as successful quitters. From the present study, the efficacy of varenicline has been firmly established in the Asian population.