Strattera (Atomoxetine) Is NOT Used to Treat Depression in Adults
Strattera (atomoxetine) is FDA-approved exclusively for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults—it is NOT approved for major depressive disorder and should not be used as an antidepressant. 1
FDA-Approved Indication
Atomoxetine is indicated solely for ADHD treatment, as explicitly stated in its FDA labeling, which notes: "Atomoxetine hydrochloride is approved for ADHD in pediatric and adult patients. Atomoxetine hydrochloride is not approved for major depressive disorder." 1
The FDA prescribing information carries a black-box warning specifically about suicidal ideation in children and adolescents with ADHD, not depression, further emphasizing its narrow indication 1
Mechanism of Action and Clinical Use
Atomoxetine is a selective norepinephrine reuptake inhibitor (not a stimulant) that works by inhibiting presynaptic norepinephrine transporters in the prefrontal cortex 2, 3, 4
Clinical trials establishing atomoxetine's efficacy were conducted exclusively in ADHD populations—seven trials in outpatients with ADHD (four in pediatric patients ages 6-18, two in adults, and one maintenance trial) 1
In adults with ADHD, atomoxetine demonstrated mean reductions in ADHD symptom scores of 28-30% versus 18-20% with placebo over 10-week trials 2
Why Atomoxetine Is Not an Antidepressant
No evidence base for depression: All published clinical trials of atomoxetine have been conducted in ADHD populations, not in patients with major depressive disorder 2, 3, 4, 5
Different pharmacology: While atomoxetine affects norepinephrine reuptake, it lacks the serotonergic activity that characterizes most modern antidepressants (SSRIs, SNRIs) 3, 6
Guideline-recommended antidepressants: For adult depression, second-generation antidepressants (SSRIs like citalopram, escitalopram, sertraline; SNRIs like venlafaxine, duloxetine; and others like bupropion, mirtazapine) are considered first-line therapy based on established efficacy 7
Appropriate First-Line Antidepressants for Adults
SSRIs and SNRIs are first-line: Preferred medications include citalopram, escitalopram, sertraline, mirtazapine, venlafaxine, and bupropion, chosen based on cost, patient preference, and adverse effect profile 7
Modest but proven efficacy: Antidepressants show number needed to treat of 7-8 for SSRIs and 7-16 for tricyclic antidepressants in achieving remission for major depressive disorder 7
Greater benefit in severe depression: Antidepressant superiority over placebo is more pronounced in patients with severe depression compared to mild-to-moderate depression 7
Common Pitfall to Avoid
Do not use atomoxetine off-label for depression: There is no evidence supporting its use for depressive disorders, and doing so would be prescribing outside FDA-approved indications without supporting data 1
Recognize comorbid ADHD in depressed patients: If a patient has both depression and ADHD, treat the depression first with appropriate antidepressants, then consider adding atomoxetine for ADHD symptoms once mood is stabilized (though this specific scenario is not directly addressed in the evidence provided)