If you or a loved one has fibromyalgia, you may be considering treatment options. One medication you might hear about is Savella (milnacipran).
Fibromyalgia is a long-lasting condition that most commonly affects middle-aged women. Symptoms often include pain all over the body, along with tiredness, sleep problems, and trouble thinking clearly.
Savella is one of the few medicines specifically approved by the FDA to treat fibromyalgia. It belongs to a class of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). Savella is thought to help regulate brain chemicals that affect how you feel pain. For some people, this may reduce pain and improve overall function. While Savella can help manage the symptoms of fibromyalgia, it does not cure the condition.
Below are common questions and answers about Savella for fibromyalgia.
Is Savella Right for Me?
Savella is FDA-approved to manage fibromyalgia in adults. Note that the FDA has not approved Savella for any use in children.
Savella may not be right for you if you take or recently took certain medicines called monoamine oxidase inhibitors (MAOIs).
Your health care provider will review your medicines and health history to see if Savella is right for you.
How Do I Take Savella?
Savella is a tablet that you take by mouth, either with or without food. Some people find it easier on the stomach if they take it with food.
The usual recommended dosage is 100 milligrams (mg) per day, divided into two doses of 50 mg each. To help your body adjust to the medicine, Savella treatment usually begins with a low dose that is slowly increased over the first week.
Here is an example of a typical starting schedule for Savella:
- Day 1: 12.5 mg once
- Days 2-3: 12.5 mg twice daily
- Days 4-7: 25 mg twice daily
- Day 8 and on: 50 mg twice daily
In some cases, if your fibromyalgia symptoms are not well-managed and the medicine is well-tolerated, your dose may be increased to 200 mg per day (taken as 100 mg twice daily).
Always follow your prescriber's exact directions, since your dosage may differ based on your health, such as your kidney health, and how your body responds to the medicine. Do not stop Savella suddenly, as this can cause withdrawal symptoms. If you need to stop, your prescriber will guide you through a gradual taper.
Is Savella Addictive?
When you're considering a pain medicine, you may worry about risks such as becoming "addicted" to it. Unlike some pain medicines, Savella is not a controlled substance. It does not carry risks of misuse or addiction.
That said, your body can get used to having Savella, and stopping it suddenly can cause unpleasant withdrawal symptoms. These symptoms may include:
- Bad moods, mood changes, or feeling cranky without a clear reason
- Dizziness
- Unusual sensations sometimes described as "electric shocks"
- Anxiety
- Confusion
- Headache
- Low energy
- Trouble sleeping
- Ringing in your ears
- Seizures
For this reason, it is important not to suddenly stop Savella unless your doctor recommends it. If you need to stop Savella, your doctor will likely lower your dose over a period of time rather than stopping all at once. If withdrawal symptoms become uncomfortable, your doctor may adjust the plan and reduce the dose more gradually.
How Does Savella Work for Fibromyalgia?
Savella belongs to a group of antidepressant medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). While other SNRIs are used to treat depression, Savella is not approved for that use. Instead, it is one of only a few medications specifically approved by the FDA to treat fibromyalgia.
The exact way Savella works for fibromyalgia is not fully understood. It is thought to increase the levels of two brain chemicals – norepinephrine and serotonin – that help regulate how the body senses and responds to pain. People with fibromyalgia are thought to have heightened sensitivity to pain, and adjusting these brain chemicals can reduce that sensitivity.
How Was Savella Studied for Fibromyalgia?
Two clinical studies were done to see how well Savella worked for treating fibromyalgia in adults. In these studies, some people received Savella, and others received a placebo (a pill with no active medicine). Neither the people in the studies nor the investigators knew who was getting which until the studies ended.
Both studies included adults ages 18 to 74 who met certain criteria for fibromyalgia, including widespread pain lasting at least three months and pain in at least 11 out of 18 specific tender point sites. These are areas of the body that are extra sensitive to pain when pressed. About 35% of people in the study had a history of depression.
Study 1 included 888 people. The average age was about 49 years old. Most were women (about 95%). The majority of the people in the study were White (93%-95%), and the others were Black (3%-5%), Asian (fewer than 1%), American Indian/Alaska Native (fewer than 1%), or identified as other races (fewer than 2%). There were 1,196 adults in Study 2. The average age was about 50 years old. Most were female (96%) and White (94%). Fewer than 4% were Black, fewer than 2% were Asian, 1% or fewer were Native American, and 2% or fewer identified as other races.
Study 1 was six months long and compared Savella (100 mg or 200 mg per day) to a placebo. To join this study, people needed to have a pain score of at least 50 on a 100-point scale where a score of zero means "no pain" and 100 means "worst possible pain." At the start of the study, the average pain score was 69.
Study 2 was three months long and compared the same doses of Savella to a placebo. To join, people needed a pain score of at least 40 on the same 100-point scale. At the start, the average pain score was 65.
For both studies, the main goal was to see how many people had at least a 30% reduction in pain and rated themselves as feeling "much" or "very much" improved. Also, the studies looked at other common symptoms of fibromyalgia, such as fatigue and problems with memory or concentration, to see if Savella could help in those areas too.
What Are the Main Benefits of Savella, Based on Studies?
In both clinical trials, more people taking Savella had meaningful improvement, compared with those taking a placebo. Researchers measured this by looking for:
- A reduction in pain (at least 30% improvement from the start of the study)
- A patient's own rating of being "much improved" or "very much improved" overall
Here are some of the main results:
- Study 1: More people taking Savella at 100 mg or 200 mg per day reached these improvement goals, compared with people taking a placebo. Another notable finding was that increasing the dose to 200 mg did not work better than the 100-mg dose.
- Study 2: The results were similar. People taking Savella were more likely than those taking a placebo to report less pain and an overall sense of improvement. Again, the 200 mg dose did not provide added benefit beyond 100 mg.
Together, these results show that Savella is more effective than a placebo for treating fibromyalgia. Your results may be different from what was seen in studies.
How Fast Does Savella Start to Work? How Long Until I See the Full Effects of the Medicine?
In studies, some people taking Savella reported less pain and felt "much improved" or "very much improved" overall within the first week of treatment. For others, it took longer. Full benefits were seen over three to six months, based on study results.
Keep in mind that individual results may differ from what was seen in studies. Talk with your health care provider if you have questions about what to expect or if you do not notice improvement.
What Types of Drug Interactions Can Happen With Savella?
Savella can interact with several types of medicines and supplements. Some interactions may cause serious side effects.
While not a complete list, some Savella interactions include:
Monoamine oxidase inhibitors (MAOIs). Some examples of MAOIs are linezolid and methylene blue. Taking Savella with MAOIs or too soon after stopping them can cause dangerously high serotonin levels.
Other medicines or supplements that increase serotonin levels. Examples are SSRIs, other SNRIs, triptans, opioids, buspirone, amphetamines, tryptophan, and St. John's wort. These can raise serotonin in the brain. When combined with Savella, they can lead to serotonin syndrome, which is a serious reaction that can happen when serotonin levels are too high. Symptoms of serotonin syndrome can vary but may include restlessness, confusion, a rapid heartbeat, sweating, a fever, or muscle stiffness.
Other medicines that affect the brain or nerves (central nervous system, or CNS). Because Savella affects the brain and nerves, combining it with other CNS-active medicines may raise the risk of side effects like dizziness or low blood pressure. One example is clomipramine.
Certain heart medicines. Examples are clonidine and digoxin. Combining Savella with certain heart medicines may increase the risk of side effects like low blood pressure or a rapid heartbeat. It could also cause certain blood pressure medicines to not work as well as they should. Tell your health care provider if you take these medicines and notice dizziness, fainting, or unusual heartbeats.
Medicines that increase bleeding risk. Savella may affect the release of serotonin by blood cells that help with clotting (platelets). Combining Savella with medicines that increase the risk of bleeding, such as blood thinners, NSAIDs, or aspirin, can make bleeding more likely. Tell your health care provider if you take these medicines and notice bleeding or bruising.
To help prevent interactions, give your health care provider a full list of all the prescription medications, over-the-counter medicines, vitamins, and supplements you use before you start Savella. Also check with your prescriber or pharmacist before adding or stopping any new medicines or supplements while taking Savella. Be sure to keep your medication list up to date and bring it to every appointment so your health care team can check for interactions and help you stay safe while taking Savella.
Is There Any Cost Assistance Available?
A cost assistance program is available from AbbVie, the maker of Savella. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit this website from the drugmaker for more information about Savella costs and copay savings.
You can also contact the drugmaker at 800-255-5162 to connect with a representative for financial support information and other resources.