What is the maximum recommended dosage of duloxetine (Cymbalta) for adults?

Maximum Dosage for Duloxetine

The maximum recommended dose of duloxetine is 120 mg per day, administered as 60 mg twice daily. 1, 2

FDA-Approved Maximum Dosing

• The FDA label explicitly states that the maximum dose studied and approved is 120 mg per day for all indications. 2
• This maximum applies across all FDA-approved indications including major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. 2

Indication-Specific Dosing Ceilings

While 120 mg/day is the absolute maximum, most indications do not benefit from doses exceeding 60 mg once daily:

• For fibromyalgia: 60 mg once daily is the ceiling dose—there is no evidence that dosages greater than 60 mg/day confer additional benefit, and higher dosages are associated with higher rates of adverse reactions. 3, 2
• For chronic musculoskeletal pain: 60 mg once daily is the recommended maximum—no evidence supports higher dosages, even in non-responders. 3, 2
• For diabetic peripheral neuropathic pain: The dose range is 60-120 mg daily, with number needed to treat (NNT) for 50% pain reduction of 4.9 for 120 mg/day versus 5.2 for 60 mg/day, though higher doses are clearly less well tolerated. 3, 2
• For generalized anxiety disorder and major depressive disorder: The target dose is 60 mg once daily, but some patients may benefit from doses up to 120 mg/day. 1, 2

Dose Escalation Protocol

When escalating beyond 60 mg once daily:

• Increase in 30 mg increments, allowing at least 1-2 weeks at each dose level to assess response. 1
• The typical escalation schedule is: 60 mg → 90 mg → 120 mg daily, with weekly intervals. 4
• For geriatric patients, start at 30 mg once daily for 2 weeks before increasing to 60 mg, then escalate more cautiously if needed. 1, 2

Critical Clinical Considerations

• If no response after 4-8 weeks at 120 mg daily, switch to a different medication class rather than attempting further dose increases—consider pregabalin, gabapentin, or alternative antidepressants. 1
• The majority of adverse events occur during initial dosing at 60 mg once daily; subsequent dose escalations produce few additional adverse events. 4
• Doses above 60 mg/day are associated with higher discontinuation rates due to adverse events in some studies, particularly nausea. 5

Safety Ceiling

• The studied dose range extends up to 400 mg/day (200 mg twice daily) in research settings, but the maximum approved for clinical use remains 120 mg/day. 6
• Avoid use entirely in patients with severe renal impairment (GFR <30 mL/min) or chronic liver disease/cirrhosis at any dose. 2