Treating Tobacco Use and Dependence: 2008 Update: Slide Presentation (Full)

Precautions, warnings, contraindications and side effects (see FDA package insert for complete list)

Pregnancy—Pregnant smokers should be encouraged to quit without medication. Clonidine has not been shown to be effective for tobacco cessation in pregnant smokers. (Clonidine is an FDA pregnancy Class C agent.) Clonidine has not been evaluated in breast-feeding patients.

Activities—Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine.

Side effects—Most commonly reported side effects include dry mouth (40%), drowsiness (33%), dizziness (16%), sedation (10%), and constipation (10%). As an antihypertensive medication, clonidine can be expected to lower blood pressure in most patients. Therefore, clinicians should monitor blood pressure when using this medication.

Rebound hypertension—When stopping clonidine therapy, failure to reduce the dose gradually over a period of 2-4 days may result in a rapid increase in blood pressure, agitation, confusion, and/or tremor.

Dosage

Doses used in various clinical trials have varied significantly, from 0.15-0.75 mg/day by mouth and from 0.10-0.20 mg/day transdermal (TTS), without a clear dose-response relation to treatment outcomes. Initial dosing is typically 0.10 mg bid. PO or 0.10 mg/day TTS, increasing by 0.10 mg/day per week if needed. The dose duration also varied across the clinical trials, ranging from 3-10 weeks.