What is the recommended dose of Duloxetine (Cymbalta)?

From the Guidelines

Duloxetine should be initiated at a dose of 60 mg once daily, with the option to increase to 120 mg daily for patients who do not respond adequately to the lower dose, as evidenced by multicenter randomized trials showing efficacy in the treatment of pain associated with diabetic peripheral neuropathy (DPN) 1. The recommended dosing strategy for duloxetine is based on its efficacy and safety profile, which has been established through numerous clinical trials.

• The initial dose of 60 mg once daily is typically well-tolerated and effective for many patients, with some studies suggesting that this dose can improve neuropathy-related quality of life 1.
• For patients who do not respond adequately to the initial dose, increasing to 120 mg daily may provide additional pain relief, although this should be done with caution and careful monitoring of adverse events, particularly in older adults 1.
• It is essential to note that duloxetine can cause adverse events, such as nausea and dizziness, which can be minimized by gradual titration and careful dose adjustment.
• The use of duloxetine for the treatment of diabetic peripheral neuropathic pain is supported by the most recent and highest quality evidence, which prioritizes its use as a first-line therapy over other options, such as tapentadol, due to the high risk of addiction and safety concerns associated with opioids 1.

From the FDA Drug Label

2.2 Dosage for Treatment of Major Depressive Disorder in Adults The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily) 2.3 Dosage for Treatment of Generalized Anxiety Disorder Recommended Dosage in Adults Less than 65 Years of Age For most adults less than 65 years of age with GAD, initiate duloxetine delayed-release capsules 60 mg once daily 2.4 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain in Adults Administer 60 mg once daily in adults with diabetic peripheral neuropathic pain. 2.5 Dosage for Treatment of Fibromyalgia The recommended duloxetine delayed-release capsules dosage is 60 mg once daily in adults with fibromyalgia. 2.6 Dosage for Treatment of Chronic Musculoskeletal Pain in Adults The recommended duloxetine delayed-release capsules dosage is 60 mg once daily in adults with chronic musculoskeletal pain.

The recommended dose of duloxetine varies by condition:

• Major Depressive Disorder (MDD): 40-60 mg/day
• Generalized Anxiety Disorder (GAD): 60 mg once daily
• Diabetic Peripheral Neuropathic Pain: 60 mg once daily
• Fibromyalgia: 60 mg once daily
• Chronic Musculoskeletal Pain: 60 mg once daily 2

From the Research

Duloxetine Dose Information

• The target dose for the majority of patients is 60 mg/day, given once daily 3.
• Higher duloxetine doses (up to 120 mg/day) have been studied using a twice-daily dosing schedule 3.
• A study compared the effects of starting doses of duloxetine taken with or without food on tolerability and efficacy in patients with major depressive disorder (MDD), and found that starting duloxetine at 30 mg q.a.m. for 1 week with or without food or starting duloxetine at the therapeutic dose of 60 mg q.a.m. with food can improve the initial tolerability of the medication 4.
• Duloxetine has demonstrated efficacy for the treatment of major depressive disorder (MDD) at a dose of 60 mg/day (given once daily) 3.

Safety and Tolerability

• The rate of discontinuation due to adverse events during the acute phase of the study was 15.6% 3.
• The most frequently reported treatment-emergent adverse events (TEAEs) were nausea, headache, dry mouth, dizziness, and decreased appetite 3.
• A systematic review of 85 studies confirmed that duloxetine is effective, safe, and tolerable for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), neuropathic pain (NP), fibromyalgia (FMS), and stress incontinence urinary (SUI) 5.

Efficacy

• Duloxetine was effective for the treatment of MDD and was well tolerated in clinical trials 6.
• Significant improvements were observed in all assessed depression efficacy measures, and in five of six VAS pain outcomes, during acute phase treatment 3.
• The dual mechanism of duloxetine benefits the treatment of comorbid clinical conditions, and supports the efficacy, safety, and tolerability of duloxetine in short- and long-term treatments 5.