What is the maximum recommended daily dose of buspirone for anxiety in adults and adolescents?

Maximum Dose for Buspirone

The maximum recommended daily dose of buspirone is 60 mg per day, typically administered as 20 mg three times daily. 1

FDA-Approved Maximum Dosing

• The FDA label explicitly states that "the maximum daily dosage should not exceed 60 mg per day" 1
• In clinical trials that allowed dose titration, divided doses of 20-30 mg per day were most commonly employed 1
• The maximum dose of 60 mg/day translates to 20 mg administered three times daily 2, 3

Standard Therapeutic Dosing Range

• Target therapeutic dose is 15-30 mg/day, which is effective for most patients with generalized anxiety disorder 2
• Initial dosing starts at 15 mg daily (7.5 mg twice daily), with increases of 5 mg per day at intervals of 2-3 days as needed 1
• Long-term safety data demonstrates that most patients are successfully managed on daily doses ranging from 15-30 mg/day 4

Titration to Maximum Dose

• Dose increases should occur gradually by 5 mg increments every 2-3 days 1
• Allow 2-4 weeks at each dose level before further titration to assess therapeutic response, as buspirone has a characteristic lag time to onset of anxiolytic effect 3
• If inadequate response persists after reaching 30 mg/day and allowing adequate time (2-4 weeks), further increases toward the maximum of 60 mg/day may be warranted 3

Special Population Considerations

Hepatic or Renal Impairment

• Buspirone administration to patients with severe hepatic or renal impairment cannot be recommended 1
• Pharmacokinetic studies show that Cmax and AUC increased 15-fold in patients with hepatic impairment compared to healthy individuals 5
• In patients with renal impairment, Cmax and AUC increased 2-fold after a single 20 mg dose 5

Elderly Patients

• Elderly or debilitated patients should start at lower doses (2.5-5 mg twice daily) and titrate more gradually 2
• However, the same maximum dose of 60 mg/day applies, as safety profiles were similar between elderly (≥65 years) and younger patients in clinical trials 1

Pediatric Patients

• Doses studied in pediatric patients (ages 6-17) ranged from 7.5 mg to 30 mg twice daily (15-60 mg/day) 1
• Peak plasma concentrations are significantly higher in children compared to adolescents and adults at equivalent doses, though the same maximum of 60 mg/day was studied 6

Critical Timing Considerations

• Buspirone requires 2-4 weeks of continuous dosing before patients notice anxiolytic benefits 2
• Full therapeutic trial requires 4-8 weeks before determining efficacy 2
• Do not increase doses too rapidly, as premature dose escalation may lead to unnecessarily high doses and increased side effects 3

Food Effects on Dosing

• Buspirone bioavailability increases when given with food compared to the fasted state 1
• Administration with food increased Cmax and AUC of buspirone 2-fold 5
• Patients should take buspirone in a consistent manner with regard to timing of dosing: either always with or always without food 1