Savella (Milnacipran): FDA-Approved Fibromyalgia Uses

Savella (milnacipran) is an FDA-approved fibromyalgia treatment that helps to ease pain and fatigue and improve sleep. A serotonin-norepinephrine reuptake inhibitor, or SNRI, Savella is a non-sedating pain reliever that may also improve energy in people with fibromyalgia. There is currently no generic version of Savella.

This article discusses the benefits, dosage, and side effects of Savella and explores when generic milnacipran might hit the market.

What Is Savella?

Savella belongs to a class of drugs known as 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.

In Europe, milnacipran is sold as an antidepressant 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.

Savella eases the pain associated with fibromyalgia, but it is not an opioid. Savella is non-narcotic and has a low risk of abuse.

What Does Savella Do?

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, neuropathic pain, depression, and a handful of other conditions.

Savella, however, is 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 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 (titrate) to the full amount. Your healthcare provider may start you with a Savella titration pack with increasing doses over the first week.

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 milnacipran 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.