Savella for Fibromyalgia

FDA-Approved Since 2009

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What Savella Is:

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.

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.

Savella's History:

Milnacipran, the generic name for Savella, is sold in Europe under the brand names Dalcipran and Ixel.

Milnacipran drugs have been on the market for more than a decade and are approved for depression in more than 50 countries.

What Savella Does:

Savella, like Cymbalta, increases levels of the neurotransmitters serotonin and norepinephrine, which can be low in people with fibromyalgia. Savella, however, is the first drug 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 increase in symptoms, including pain and fatigue. However, a 2015 review (Cording) concluded that it's only effective for about 40% of those who take it.

Savella Dosage:

The recommended dosage of Savella is 50 mg twice a day. It's typical to start at a smaller dosage and gradually work up to the full amount.

Savella Side Effects:

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

Talk to your doctor and/or pharmacist about all of your medical conditions and possible interactions with other drugs you may be taking.


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.

Gendreau RM, et al. Journal of rheumatology. 2005 Oct;32(10):1975-85. Efficacy of milnacipran in patients with fibromyalgia.

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.

Vitton O, et al. Human psychopharmacology. 2004 Oct;19 Suppl 1:S27-35. A couble-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia.

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