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Controlled Clinical Trials

Systemic Adverse Effects: In controlled clinical trials of patients treated with Zonalon (doxepin) Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with Zonalon (doxepin) Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with Zonalon (doxepin) Cream in controlled clinical trials.

Local Site Adverse Effects: In controlled clinical trials of patients treated with Zonalon (doxepin) Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with Zonalon (doxepin) Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with Zonalon (doxepin) Cream withdrew from the study because of the burning and/or stinging.

The table below presents the adverse events reported at an incidence of ≥ 1 % in either Zonalon (doxepin) or vehicle cream treatment groups during the trials:

Adverse Event Zonalon
N=330
Vehicle
N=334
Burning /Stinging 76 (23.0%) 54 (16.2%)
Drowsiness 71 (21.5%) 7 (2.1%)
Dry Mouth1 32 (9.7%) 4 (1.2%)
Pruritus2 13 (3.9%) 20 (6.0%)
Fatigue/Tiredness 10 (3.0%) 5 (1.5%)
Exacerbated Eczema 10 (3.0%) 8 (2.4%)
Other Application Site Reaction3 10 (3.0%) 16 (4.8%)
Dizziness4 7 (2.1%) 3 (0.9%)
Mental Emotional Changes 6 (1.8%) 1 (0.3%)
Taste Perversion5 5 (1.5%) 1 (0.3%)
Edema 4 (1.2%) 1 (0.3%)
Headache 3 (0.9%) 14 (4.2%)
1 Includes reports of "dry lips", "dry throat", and "thirst"
2Includes reports of "Pruritus Exacerbated"
3Includes report of "increased irritation at application site"
4Includes reports of "lightheadedness" and "dizziness/vertigo"
5Includes reports of "bitter taste" and "metallic taste in mouth"

Adverse events occurring in 0.5% to < 1.0% of Zonalon (doxepin) Cream treated patients in the controlled clinical trials included: nervousness/anxiety, tongue numbness, fever, and nausea.

Post Marketing Experience

Twenty-six cases of allergic contact dermatitis have been reported in patients using Zonalon (doxepin) Cream, twenty of which were documented by positive patch test to doxepin 5% cream.