Is Straterra (atomoxetine) a controlled substance?

Strattera (Atomoxetine) Is Not a Controlled Substance

No, Strattera (atomoxetine) is not a controlled substance. 1 Unlike stimulant medications commonly used for ADHD, atomoxetine carries negligible risk of abuse or misuse and is not classified under controlled substance regulations.

Classification and Mechanism

Atomoxetine is a selective norepinephrine reuptake inhibitor (SNRI) that works by:

• Binding to the norepinephrine transporter, increasing synaptic noradrenaline 2
• Increasing both noradrenaline and dopamine in the prefrontal cortex 2
• Acting through a different mechanism than stimulant medications used for ADHD

Clinical Implications of Non-Controlled Status

The non-controlled status of atomoxetine offers several practical advantages:

• Prescription convenience: No special prescription requirements or limitations on refills

• Suitable for high-risk populations: Particularly beneficial for patients with:

  • History of substance use disorders
  • Risk of stimulant abuse
  • Active substance use 3
  • Patients who do not wish to take a controlled substance 4

• Abuse potential: Clinical studies have demonstrated that atomoxetine:

  • Is not associated with a pattern of response suggesting stimulant or euphoriant properties 1
  • Shows only isolated incidents of drug diversion or inappropriate self-administration in clinical studies 1
  • Has a subjective-effects profile different from stimulants like methylphenidate 4

Administration and Dosing

Atomoxetine can be administered:

• As a single daily dose or split into two evenly divided doses 2, 5
• With a maximum recommended dosage of 1.4 mg/kg/day or 100 mg/day, whichever is lower 2
• With evening-only dosing possible to reduce adverse effects 3

Important Monitoring Considerations

Despite not being controlled, atomoxetine requires careful monitoring for:

• Suicidal ideation: FDA black box warning based on meta-analysis showing higher incidence than placebo, particularly during the first few months of treatment 2, 3
• Cardiovascular effects: Modest increases in heart rate and blood pressure that are generally well tolerated 6
• Hepatic effects: Rare cases of serious liver injury have been reported 5

Comparison to Stimulant Medications

Unlike stimulant medications for ADHD (methylphenidate, amphetamines) which are controlled substances:

• Atomoxetine provides 24-hour symptom control 3
• Has different side effect profile (more somnolence, less insomnia compared to stimulants) 5
• May be particularly beneficial for patients with comorbid anxiety or tics 7

The non-controlled status of atomoxetine makes it a valuable alternative for patients who need ADHD treatment but for whom stimulant medications may be contraindicated or undesirable.