Maximum Dose of Duloxetine
The maximum recommended dose of duloxetine is 120 mg per day, administered as 60 mg twice daily. 1
FDA-Approved Maximum Dosing
- The FDA label explicitly states that the maximum approved dose for marketing is 120 mg/day (administered as 60 mg twice daily), even though doses up to 400 mg/day have been studied in clinical trials 1, 2
- For most indications, there is no evidence that doses greater than 60 mg/day confer additional benefits 1
Indication-Specific Maximum Doses
Major Depressive Disorder
- While 120 mg/day has been shown to be effective, there is no evidence that doses greater than 60 mg/day provide any additional benefits 1
- The typical dosing range is 40-60 mg/day, with 60 mg once daily being the target dose for most patients 1
Generalized Anxiety Disorder
- The maximum dose studied was 120 mg per day 1
- For adults under 65 years, start at 60 mg once daily; if increasing beyond 60 mg, do so in 30 mg increments 1
- For pediatric patients (7-17 years), the maximum dose studied was also 120 mg per day 1
Diabetic Peripheral Neuropathic Pain
- The recommended dose is 60 mg once daily 1
- There is no evidence that doses higher than 60 mg once daily confer additional significant benefit, and the higher dosage is clearly less well tolerated 1
- Despite this, the FDA-approved dosing range is 60-120 mg daily, with number needed to treat (NNT) for 50% pain reduction of 4.9 for 120 mg/day and 5.2 for 60 mg/day 3
Fibromyalgia
- The recommended dose is 60 mg once daily 1
- There is no evidence that dosages greater than 60 mg/day confer additional benefit, even in patients who do not respond to 60 mg/day, and higher dosages are associated with higher rates of adverse reactions 1
Chronic Musculoskeletal Pain (Osteoarthritis, Low Back Pain)
- Start at 30 mg daily for one week, then 60 mg daily 3
- For suboptimal response after 7 weeks at 60 mg, the option exists to increase to 120 mg daily 3
Clinical Considerations When Approaching Maximum Dose
- If no response occurs after reaching 120 mg once daily for 4-8 weeks, switch to a different medication class rather than attempting further dose increases 3
- Common adverse effects (nausea, dry mouth, headache, constipation, dizziness) are dose-dependent and more common at 120 mg daily than at 60 mg daily 3, 4
- Approximately 16% of participants stop duloxetine due to adverse effects, with nausea being the primary reason for discontinuation 4
Special Population Adjustments
- For patients with renal insufficiency (creatinine clearance <30 mL/min), avoid duloxetine or consider a lower starting dose with gradual titration 1, 5
- For geriatric patients with GAD, initiate at 30 mg once daily for 2 weeks before considering an increase to 60 mg/day 1
- Patients with hepatic impairment should avoid duloxetine 5