CFS & Fibromyalgia Fibromyalgia Savella for Fibromyalgia FDA-Approved Since 2009 By Adrienne Dellwo Adrienne Dellwo LinkedIn Adrienne Dellwo is an experienced journalist who was diagnosed with fibromyalgia and has written extensively on the topic. Learn about our editorial process Medically reviewed by David Ozeri, MD Medically reviewed by David Ozeri, MD on September 26, 2020 LinkedIn David Ozeri, MD, is a board-certified rheumatologist from Tel Aviv, Israel specializing in arthritis, autoimmune diseases, and biologic therapies. Learn about our Medical Review Board on September 26, 2020 Print Savella (milnacipran) was FDA-approved in January 2009 as a fibromyalgia treatment. At that time, it was a new drug to the U.S. marketplace. Because it's so new, there's no generic form available yet. Callista Images / Getty Images Savella is a serotonin-norepinephrine reuptake inhibitor, or SNRI. By definition, SNRIs are antidepressants. However, Savella isn't approved for depression in the U.S. So far, fibromyalgia is its only approved use in the states. However, milnacipran is sold as an antidepressant in Europe under several brand names, including Dalcipran, Ixel, and others. Milnacipran drugs have been available in foreign markets for more than a decade and are approved for depression in more than 50 countries. What Savella Does Savella increases levels of the neurotransmitters serotonin and norepinephrine, which can be low in people with fibromyalgia. That puts it in the same class as Cymbalta, which is FDA-approved for fibromyalgia, neuopathic pain, depression, and a handful of other conditions. Savella, however, is the reported to increase norepinephrine more than serotonin. The New Drug Application for Savella, filed in December of 2007, included data from two Phase III trials involving more than 2,000 patients. The company says data showed Savella was more effective than a placebo and was well tolerated. There were no deaths during the course of the studies and the majority of side effects were described as mild to moderate. Later studies have supported early results, showing a significant improvement in symptoms, including pain, fatigue, and sleep. However, a 2015 review concluded that it's only effective for about 40 percent of those who take it. That's similar to the effectiveness rates for Cymbalta and the other FDA-approved fibromyalgia drug, Lyrica (pregabalin). Savella Dosage The recommended dosage of Savella is 100 mg or 200 mg per day, split into two doses. It's typical to start at a smaller dosage and gradually work up to the full amount. It's not safe to suddenly stop taking Savella. If you want to go off of the drug, be sure to talk to your healthcare provider about the proper weaning procedure. Savella Side Effects Like all drugs, Savella can cause some unpleasant side effects. Not everyone gets them, but you should be aware of what they are when you start taking this drug. Some of the side effects can be serious. Get medical help right away if you have any of the following symptoms: Severe allergic reaction (rash, hives itching, difficulty breathing, tightness in the chest, swelling of the face, lips or tongue) Bizarre behavior Bloody or black tarry stools Confusion Dark urine Excessive sweating Fainting Rapid or irregular heartbeat Fever Chills Persistent sore throat Hallucinations Loss of coordination Memory problems Muscle pain or weakness New or worsening agitation, anxiety, depression, panic attacks, aggression, impulsiveness, irritability, anger, restlessness or inability to sit still Pale stools Red, swollen, blistered or peeling skin Seizures Severe or persistent headache or dizziness Severe or persistent nausea Vomiting or diarrhea Severe or persistent trouble sleeping Stomach pain Suicidal thoughts or behaviors Tremor Trouble urinating Unusual bruising or bleeding Unusual or severe mental or mood changes Unusual weakness Yellowing of the skin or eyes (jaundice) Side effects that don't generally require medical attention include: Constipation Decreased sexual desire or performance Dizziness Dry mouth Headache Hot flushes Increased sweating Loss of appetite Nausea Trouble sleeping It's possible for drugs to interact negatively with each other. Talk to your healthcare provider and/or pharmacist about all of your medical conditions and possible interactions with other drugs you may be taking. A Word From Verywell We never know what drug(s) will help us until we try them. If you want to try Savella, talk to your healthcare provider about the pros and cons and make the decision together. Watch for side effects as your body adjusts to the drug and give it some time to work. Was this page helpful? Thanks for your feedback! Learn about treatment and lifestyle changes to cope with fibromyalgia and chronic fatigue syndrome. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit 0 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Ahmed M, et al. Journal of clinical sleep medicine. 2015 Sep 14. pii: jc-00381-14. The effects of milnacipran on sleep disturbance in fibromyalgia: a randomized, double-blind, placebo-controlled, two-way crossover study. Cording M, et al. Cochrane database of systematic reviews. 2015 Oct 20;10:CD008244. Milnacipran for pain in fibromyalgia in adults. Mease PJ, Palmer RH, Wang Y. Journal of clinical rheumatology. 2014 Jun;20(4):195-202. Effects of milnacipran on the multidimensional aspects of fatigue and the relationship of fatigue to pain and function: polled analysis of 3 fibromyalgia trials. Staud R, et al. Journal of pain. 2015 Aug;16(8):750-9. Effects of milnacipran on clinical pain and hyperalgesia of patients with fibromyalgia: results of a 6-week randomized controlled trial.