What diagnosis is required to get Strattera (atomoxetine) approved?

Strattera (Atomoxetine) Requires an ADHD Diagnosis for Approval

Strattera (atomoxetine) is FDA-approved exclusively for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults—no other diagnosis will secure insurance approval or meet prescribing indications. 1

FDA-Approved Indication

• Atomoxetine is indicated solely for ADHD treatment across all age groups (children 6 years and older, adolescents, and adults). 1
• The diagnosis must meet DSM criteria for ADHD with documented symptoms of inattention and/or hyperactivity-impulsivity causing functional impairment. 2
• Unlike stimulants, atomoxetine is not approved for narcolepsy, treatment-refractory depression, or adjuvant medical uses. 2

Position in Treatment Algorithm

First-Line vs. Second-Line Status (Geography-Dependent)

• United States: Atomoxetine is FDA-approved as a first-line therapy for ADHD. 2
• Europe and many Asian countries: Atomoxetine is designated as second-line therapy, reserved for patients who fail or cannot tolerate stimulants. 2
• Japan: Atomoxetine is considered first-line alongside OROS-methylphenidate and extended-release guanfacine due to strict stimulant controls. 2

When Atomoxetine is Particularly Appropriate

Atomoxetine should be prioritized in specific clinical scenarios where it offers advantages over stimulants:

• Comorbid substance use disorders: Atomoxetine has negligible abuse potential and is not a controlled substance, making it ideal for patients at risk of stimulant diversion or abuse. 2, 3, 4
• Comorbid anxiety disorders: Does not worsen anxiety symptoms, unlike stimulants which may exacerbate anxiety. 2
• Comorbid tic disorders or Tourette's syndrome: Does not worsen tics. 2
• Adolescents at risk for medication diversion: Particularly useful when diversion concerns exist in school or social settings. 2
• Patients requiring 24-hour symptom coverage: Provides "around-the-clock" effects without afternoon/evening rebound seen with short-acting stimulants. 2
• Patient/family preference against controlled substances: Some families prefer non-stimulant options for personal or philosophical reasons. 2

Contraindications That Would Prevent Approval

Even with an ADHD diagnosis, atomoxetine is contraindicated in:

• Hypersensitivity to atomoxetine or product constituents. 1
• Use within 2 weeks of MAOI discontinuation. 1
• Narrow-angle glaucoma. 1
• Pheochromocytoma or history thereof. 1
• Severe cardiovascular disorders that might deteriorate with increases in heart rate and blood pressure. 1

Documentation Requirements for Approval

To secure insurance authorization, documentation should include:

• Confirmed ADHD diagnosis using DSM criteria with specific symptom documentation (inattention, hyperactivity-impulsivity). 2
• Functional impairment in multiple settings (home, school, work). 2
• Prior treatment history if atomoxetine is being used as second-line (in regions where this applies): document stimulant trials, dosages, duration, response, and reasons for discontinuation or contraindication. 2
• Comorbidity documentation if present (substance use disorder, anxiety, tics) to justify first-line atomoxetine use. 2
• Cardiovascular screening: Document absence of contraindicated cardiac conditions. 1

Common Pitfalls to Avoid

• Off-label use attempts: Atomoxetine is not approved for depression, anxiety alone, or cognitive enhancement—these will not secure approval. 2, 1
• Inadequate ADHD documentation: Vague symptom descriptions or single-setting impairment may result in denial. 2
• Missing prior authorization requirements: In regions where atomoxetine is second-line, failure to document adequate stimulant trials will result in denial. 2
• Overlooking contraindications: Prescribing with concurrent MAOIs, pheochromocytoma, or narrow-angle glaucoma violates FDA labeling. 1

Efficacy Considerations

• Atomoxetine has a smaller effect size (0.7) compared to stimulants (1.0) but is significantly more effective than placebo. 2
• Onset of therapeutic effects requires 6-12 weeks, unlike stimulants which work within hours. 2
• It is significantly less effective than OROS-methylphenidate and extended-release mixed amphetamine salts in head-to-head trials. 3, 5