Atomoxetine Refill Limits
Atomoxetine (Strattera) is not a controlled substance and has no federal restrictions on the number of refills that can be prescribed—you may authorize up to 12 months of refills (or up to 5 refills for a 6-month supply) on a single prescription, unlike stimulant medications which require new prescriptions every 30 days. 1, 2
Key Regulatory Distinctions
Atomoxetine is FDA-approved as a non-controlled substance, meaning it does not fall under DEA scheduling restrictions that apply to stimulant medications like methylphenidate or amphetamines 1, 2
No abuse liability has been demonstrated in clinical studies, which is the primary reason atomoxetine avoids controlled substance classification 1, 2
Standard state pharmacy regulations for non-controlled prescription medications apply, typically allowing prescriptions valid for 12 months from the date written 1
Practical Prescribing Approach
For stable patients on maintenance atomoxetine therapy, prescribe 90-day supplies with 3 refills (covering 12 months total) to minimize pharmacy visits while ensuring adequate monitoring opportunities. 2, 3
Monitoring Schedule During Refill Period
Initial titration phase (first 6-12 weeks): Monthly visits or phone contacts to assess response, as atomoxetine requires 6-12 weeks to achieve full therapeutic effect 4
Maintenance phase: Quarterly monitoring is appropriate once stable dosing achieved, checking for continued efficacy, side effects, blood pressure, pulse, height, and weight 5
Suicidality monitoring: Close surveillance especially during first few months and at dose changes, given the black-box warning for suicidal ideation 4, 2
Common Pitfall to Avoid
Do not treat atomoxetine like a stimulant by requiring monthly prescription renewals—this creates unnecessary burden for patients and families without any regulatory requirement or clinical benefit, and may reduce medication adherence in a population already challenged by ADHD-related organizational difficulties. 1, 2