Milnacipran Hydrochloride in the Treatment of Fibromyalgia Syndrome: Safety, Efficacy and Tolerability

Fibromyalgia is a central sensitization disorder characterized by chronic widespread pain, nonrestorative sleep, fatigue, cognitive dysfunction as well as a number of somatic symptoms; that reduces physical/emotional function/quality of life. Treatment options include: Patients education, behavioral medicine strategies, (eg, cognitive behavioral therapy), physical medicine strategies (eg, exercise/aerobic and strength training), and pharmacologic agents. Currently there are three agents approved by the US Federal Drug Administration for the treatment of Fibromyalgia: pregabalin, duloxetine, and milnacipran. Milnacipran is a norepinephrine-serotonin reuptake inhibitor that is only approved in the US for fibromyalgia. It has 3-fold increased selectivity for norepinephrine compared to serotonin. Milnacipran is well absorbed (85% bioavailability), has a half-life of 6–8 hours, and does not undergo cytochrome P450 metabolism. Milnacipran in doses of 50 mg PO BID to 100 mg PO BID has been shown to have efficacy for fibromyalgia. The most common adverse effect is nausea.