Doxepin

Symptoms of depressive illness in adults, especially where sedation is required.

SILENOR (doxepin tablet) is indicated for: • the treatment and symptomatic relief of insomnia characterized by frequent nocturnal awakening, and/or early morning awakenings. The clinical trials performed in support of efficacy were up to 1 month duration in adults and 3 months in duration in the elderly (≥ 65 years of age).

1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): During clinical trials, no overall differences in safety or effectiveness were observed in elderly and adult patients, however greater sensitivity of some older individuals cannot be ruled out.

INDICATIONS AND USAGE

Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).

Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin HCl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.

Clinical experience has shown that doxepin HCl is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin HCl is not recommended for use in children under 12 years of age.