What is the maximum recommended dose of Cymbalta (duloxetine) per day?

Maximum Recommended Dose of Cymbalta (Duloxetine)

The maximum recommended dose of Cymbalta (duloxetine) is 120 mg per day, although there is no evidence that doses greater than 60 mg/day confer additional benefits for most conditions. 1

FDA-Approved Dosing Guidelines by Condition

Diabetic Peripheral Neuropathic Pain

• Standard dose: 60 mg once daily
• Maximum dose: 60 mg once daily
• Note: There is no evidence that doses higher than 60 mg confer additional significant benefit, and higher doses are clearly less well tolerated 1

Major Depressive Disorder

• Starting dose: 40-60 mg/day (given as 20 mg twice daily or 30-60 mg once daily)
• Maximum dose: 120 mg/day
• Note: While 120 mg/day was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefits 1

Generalized Anxiety Disorder

• Standard dose: 60 mg once daily
• Maximum dose: 120 mg once daily
• Note: While 120 mg once daily was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit 1

Fibromyalgia

• Recommended dose: 60 mg once daily
• Maximum dose: 60 mg once daily
• Note: There is no evidence that dosages greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg/day dosage 1

Dose-Related Considerations

Efficacy vs. Side Effects

• Higher doses (120 mg/day) do not consistently demonstrate greater efficacy than the standard 60 mg/day dose 2
• Adverse events are dose-dependent, with higher rates at 120 mg compared to 60 mg 3
• Approximately 16% of patients discontinue duloxetine due to adverse effects 3

Special Populations

• Geriatric patients: Start at 30 mg once daily for 2 weeks before considering an increase to 60 mg/day 1
• Renal impairment: Consider lower starting dosage and gradual increase in dosage 1
• Patients with tolerability concerns: Lower starting dose may be considered 1

Administration Guidelines

• Administer orally (with or without meals)
• Swallow capsules whole - do not chew, crush, open, or sprinkle contents
• Can be taken without regard to food or time of day 1

Common Adverse Effects

• Most common: nausea, dry mouth, headache, constipation, dizziness, and fatigue 4
• At higher doses: potential for blood pressure elevation, diaphoresis, tachycardia, tremors, and anxiety 4
• Discontinuation-emergent adverse events (most commonly nausea and dizziness) occur in up to one-third of patients 5

While the absolute maximum dose approved is 120 mg/day, clinicians should be aware that for most indications, especially diabetic peripheral neuropathic pain and fibromyalgia, the 60 mg/day dose provides optimal benefit with fewer side effects.