Maximum Recommended Dose of Cymbalta (Duloxetine)
The maximum recommended dose of duloxetine (Cymbalta) is 120 mg per day. 1
Dosing Guidelines by Indication
Diabetic Peripheral Neuropathic Pain
- Standard dose: 60 mg once daily 2
- Maximum dose: 60 mg once daily 1
- There is no evidence that doses higher than 60 mg once daily confer additional significant benefit for diabetic neuropathic pain, and higher dosages are clearly less well tolerated 1
Generalized Anxiety Disorder (GAD)
- Initial dose: 60 mg once daily (for most adults under 65 years)
- For some patients, starting at 30 mg once daily for 1 week may help adjustment
- Maximum dose: 120 mg once daily 1
- 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
Major Depressive Disorder
- Standard dose: 60 mg once daily (or 30 mg twice daily)
- Maximum dose: 120 mg per day 1
Fibromyalgia
- Recommended dose: 60 mg once daily
- Maximum dose: 60 mg once daily 1
- No evidence that dosages greater than 60 mg/day confer additional benefit 1
Chronic Musculoskeletal Pain
- Recommended dose: 60 mg once daily
- Maximum dose: 60 mg once daily 1
- No evidence that higher dosages confer additional benefit 1
Special Population Considerations
Elderly Patients (≥65 years)
- For GAD: Start with 30 mg once daily for 2 weeks before considering increase to 60 mg/day 1
- Maximum studied dose: 120 mg per day 1
Renal Impairment
- Avoid use in patients with severe renal impairment (GFR <30 mL/minute) 1
- Consider lower starting dose and gradual increase for patients with renal impairment 1
Hepatic Impairment
- Avoid use in patients with chronic liver disease or cirrhosis 1
Safety Considerations
Adverse Effects
- Most common: nausea, dry mouth, headache, constipation, dizziness, and fatigue 3
- Discontinuation-emergent adverse events: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue 1
- Starting at 30 mg QD for 1 week before increasing to 60 mg QD may reduce treatment-emergent nausea compared to starting directly at 60 mg QD 4
Discontinuation
- A gradual reduction in dosage rather than abrupt cessation is recommended to minimize discontinuation symptoms 1
Clinical Efficacy
- For diabetic peripheral neuropathy, approximately 30-40% of patients may achieve at least 50% reduction in pain with duloxetine, compared to 17-21% with placebo 5
- For fibromyalgia, duloxetine is effective at doses similar to those used in diabetic peripheral neuropathy 5
Important Warnings
- Fatal outcomes have been reported for acute duloxetine overdoses, primarily with mixed overdoses, but also with duloxetine only, including 1000 mg (approximately 8.3 times the maximum recommended dosage) 1
- Signs of overdose include somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting 1
Remember that while 120 mg per day is the maximum recommended dose, for most indications, 60 mg per day provides optimal benefit with better tolerability.