Silenor Withdrawal and Tapering Help

The safety and efficacy of doxepin for the treatment of depression and/or anxiety in children under 12 years of age have not been established. The safety and efficacy of low-dose doxepin when used as a hypnotic agent, have not been established in children and adolescents under the age of 18 years old. Use of doxepin cream in pediatric patients is not recommended, due to the potential for systemic absorption and adverse effects; one case of toxicity has been reported in a young child. In October 2004, the FDA directed manufacturers of all antidepressants to include a boxed warning detailing the risk of suicide in pediatric patients. A causal role has been established for antidepressants in inducing suicidality in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4,400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Pooled analysis of short-term clinical trials during early phase treatment with SSRIs and other antidepressants in young adults (18 to 24 years) also showed an increased risk of suicidal thinking and behavior. The clinical need for an antidepressant in children or young adults for any use must be weighed against the risk of increased suicidality; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increase or decrease; such observation would generally include at least weekly face-to-face contact with patients during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks; additional contact by telephone may be appropriate between visits. It is unknown if the suicidality risk in children or young adults extends to longer-term therapy (i.e., beyond several months). The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary psychiatric disorder. All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment are considered at an increased risk for suicidal ideation or attempts, and should be closely monitored during treatment with doxepin. In primarily depressed patients, worsening of suicidal thoughts, including suicidal ideation, has occurred in association with hypnotic use; caution is also advisable when using low-dose doxepin as a hypnotic agent. The risk of suicidal ideation in children, adolescents, and young adults from the use of low-dose doxepin as a hypnotic agent is unknown but cannot be excluded. In patients who exhibit changes in symptoms, worsening of depression or emergent suicidality, a decision should be made to change or discontinue treatment. If discontinuing, the medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. Tricyclic antidepressants (TCAs) should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.