Duloxetine was approved for the treatment of major depression in 2004. While duloxetine has demonstrated improvement in depression-related symptoms compared to placebo, comparisons of duloxetine to other antidepressant medications have been less successful. A 2012 Cochrane Review did not find greater efficacy of duloxetine compared to SSRIs and newer antidepressants. Additionally, the review found evidence that duloxetine has increased side effects and reduced tolerability compared to other antidepressants. It thus did not recommend duloxetine as a first line treatment for major depressive disorder, given the (then) high cost of duloxetine compared to inexpensive off-patent antidepressants and lack of increased efficacy. do not list duloxetine among the recommended treatment options. A review from the Annals of Internal Medicine lists duloxetine among the first line drug treatments, however, along with citalopram, escitalopram, sertraline, paroxetine, and venlafaxine. Efficacy and safety data were obtained from the acute phase portions of four randomized, double-blind, placebo-controlled clinical trials in patients meeting DSM-IV criteria for MDD. In Studies 1 and 2, patients were randomized to duloxetine 60 mg once daily (QD) ( subscales, the Clinical Global Impression of Severity (CGI-S) and Patient Global Impression of Improvement (PGI-I) scales, and Visual Analog Scales (VAS) for pain. Safety assessments included rates of discontinuation due to adverse events, spontaneously reported treatment-emergent adverse events, and changes in vital signs. Duloxetine provides safe and effective acute phase treatment of MDD at doses of 40–60 mg/day. Compared with placebo, the 60 mg QD dose was more consistently effective than the 20 mg BID dose. However, the incidence of certain treatment-emergent adverse events is likely to be lower at the 40 mg dose.
Review question Does duloxetine work to treat pain generated by nerves when they have been damaged in disease, or the pain caused by fibromyalgia? Background Duloxetine is a drug used to treat depression and urinary urge incontinence (leakage of urine) and it can be also be useful for certain types of pain. Pain can arise spontaneously when there is damage to nerves that carry pain information to the brain (neuropathic pain). When this damage is to nerves outside the spinal cord it is called a of all sorts. Study characteristics We looked at all the published scientific literature and found 18 trials, involving a total of 6407 participants, that were of sufficient quality to include in this . Eight trials tested the effect of duloxetine on painful diabetic neuropathy and six on the pain of fibromyalgia. Three trials treated painful physical symptoms associated with depression and one small investigated duloxetine for the pain from strokes or diseases of the spinal cord (central pain). The NICE British National Formulary (BNF) and British National Formulary for Children (BNFc) sites are only available to users in the UK, Crown Dependencies and British Overseas Territories. If you believe you are seeing this page in error please contact us.
The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials. However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations. After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse. In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or without food. In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients. Initial dose: 20 mg orally twice a day Maintenance dose: 60 mg per day, given either once a day or as 30 mg orally twice a day Maximum dose: 120 mg orally per day Duration: Acute episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended. Comments: -Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day -Data are lacking to show that doses greater than 60 mg per day confer any additional benefits. Use: Treatment of major depressive disorder (MDD) Initial dose: 30 mg orally once a day for 1 week Maintenance dose: 30 to 60 mg orally once a day Duration: Efficacy has been demonstrated for up to 3 months in placebo-controlled studies; effectiveness beyond this has not been demonstrated in longer studies; therefore, continued treatment should be based on individual patient response. Comments: -There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects. Initial dose: 60 mg orally once a day Maintenance dose: 60 to 120 mg orally once a day Maximum dose: 120 mg orally once a day Duration: Episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended. Comments: -Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day -The dose may be increased in increments of 30 mg once a day if clinically appropriate -There is no evidence that doses greater than 60 mg per day confer additional benefit Initial dose: 30 to 60 mg orally once a day Maintenance dose: 60 mg orally once a day Duration: -Diabetic peripheral neuropathy pain: Efficacy beyond 12 weeks has not been established; effectiveness should be based on individual patient response. -Chronic musculoskeletal pain: Efficacy beyond 13 weeks has not been established.
Duloxetine ~ Usual dosage range 40-60 mg/day in 1-2 doses for depression; 60 mg once daily for diabetic peripheral neuropathic pain and fibromyalgia; 60 mg once daily for generalized anxiety disorder; 40 mg twice daily for stress urinary incontinence Initially, 30 mg PO once daily for 2 weeks. Thereafter, an increase to 60 mg/day PO may be considered. The recommended range is 30 to 60 mg PO once daily; however, some patients may benefit from doses higher than 60 mg/day PO.