Suicidality
• Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Doxepin is not approved for use in pediatric patients <12 years of age. (See Pediatric Use under Cautions.)
• In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
• Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
• Appropriately monitor and closely observe all patients who are started on doxepin therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)

REMS:

FDA approved a REMS for doxepin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of doxepin and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).