Causes of Restless Legs Syndrome

Unpleasant sensations from Restless Legs Syndrome (Willis-Ekbom disease) can occur while sitting still or during sleep, causing an irresistible urge to move. It can be difficult to get comfortable, and sometimes a person with RLS can experience involuntary twitching or jerking.

While studies have shown that RLS has been associated with changes in the dopamine system as well as iron levels, there is no known cause. However, it is important to note that more than half of people with RLS have a family history of the condition.

There are two categories of RLS based on cause:

Primary or idiopathic means that the cause of RLS is unknown, that there is no disease-related cause. Symptoms may begin anytime in a person's life but become more common with age. About 70% of people with RLS have primary RLS.

Secondary RLS affects about 30% of people with RLS and means there's an association with other conditions, including:

  • Iron deficiency
  • Pregnancy
  • End-stage renal disease (ESRD)

NEUPRO® (rotigotine transdermal system) is a prescription medicine used to treat moderate-to-severe primary Restless Legs Syndrome (RLS). NEUPRO has not been studied in secondary RLS.

RLS is more commonly found in smokers and people who don't exercise regularly (less than three hours a month). Talk to your doctor if you have any of these conditions and you think you may have RLS.

Is RLS affecting your life?

Some people have to live their lives around their RLS symptoms. Do you?

See “How Is RLS Affecting You?” to find out >

Restless Legs Syndrome – mild and moderate-to-severe

For some, RLS can be mildly annoying, but for others it can have a much greater impact.

Mild means RLS occurs occasionally (less than 2 nights a week).

Moderate-to-severe means RLS has a negative impact on people's lives. They suffer either every day or at least twice a week. People with moderate-to-severe RLS generally get less than five hours of sleep a night. In addition to nighttime symptoms, there may be daytime symptoms too. Daily treatment may be necessary for these people.

If you're affected by moderate-to-severe primary RLS, NEUPRO may be able to help.

Prepare for your next doctor's appointment

It's not always easy to pinpoint your feelings and communicate them to your doctor. This tool will help you get started.

Build a conversation by selecting key points from the items below. Any items you selected while using the site have already been added to your list. When you are finished, you can print or email your custom list using the buttons below.

This website does not save items added to My Doctor Conversation Builder. Be sure to print or email your list of questions before leaving this website.

Prepare for your next doctor's appointment

Build a list of key points to discuss with your doctor by selecting items from the list below. Click the "Items to ask my doctor" icon at the top of the screen to view, edit, and print your list at any time.

Assess your RLS

If you think you may have RLS, it's important to understand how much of an effect the condition has on your life. It may have a bigger impact than you realize. Below are some statements that describe how people with RLS can feel. Check the ones that apply to you. This does not take the place of a doctor visit. Only your doctor can diagnose you with RLS.

NEUPRO has been approved by the FDA to treat moderate-to-severe primary RLS and the approval was based on improvements in overall symptom scores in clinical trials. The efficacy of NEUPRO for individual symptoms has not been demonstrated. The following information is provided for your education and to help you understand your disease.

Because of my RLS:

Here's a list of common terms that people with RLS use to describe what's happening in their limbs. Do any of these describe how you're feeling? Check off the descriptions that apply to add them to My Doctor Conversation Builder.

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    It looks like symptoms from RLS affect you when you are trying to rest, relax, or sit still.

    NEUPRO may help.

Indication

NEUPRO is a prescription medicine used to treat moderate-to-severe primary Restless Legs Syndrome.

NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.

Important Safety Information

NEUPRO contains a sulfite called sodium metabisulfite. Sulfites can cause severe allergic reactions that are life threatening to some people who are sensitive to sulfites. People with asthma are more sensitive to sulfites. Remove the patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.

NEUPRO may make you fall asleep suddenly or without warning while doing normal activities, such as driving, which may result in accidents. Tell your doctor right away if this happens. Drinking alcohol or taking other medicines that cause drowsiness may increase your chances of becoming sleepy while using NEUPRO. Do not drive, use hazardous machinery, or do other dangerous activities until you know how NEUPRO affects you.

NEUPRO can cause decreases in blood pressure, especially when you start or increase your dose. Increases in blood pressure and heart rate, and fainting, also can occur. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, tell your doctor.

Some patients using NEUPRO get urges to behave in a way that is unusual for them, such as unusual urges to gamble, strong urges to spend money, binge eating, or increased sexual urges and behaviors. If you or your family notices you are developing any unusual behaviors, talk to your doctor.

NEUPRO may cause Restless Legs Syndrome symptoms to come back (rebound), become worse, or start earlier in the day.

Skin reactions may occur at the site where you apply NEUPRO. Tell your doctor if you get a rash, redness, swelling, or itching that will not go away.

Avoid exposing the NEUPRO patch you are wearing to heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and direct sunlight. Too much medicine could be absorbed into your body. Also, do not wear NEUPRO during medical procedures called magnetic resonance imaging (MRI) or cardioversion because this could cause skin burns.

Tell your doctor if you have breathing problems, a sleep disorder, mental problems, high or low blood pressure, or heart problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. NEUPRO may not be right for you.

The most common side effects in people taking NEUPRO for Restless Legs Syndrome are application site reactions, nausea, difficulty falling asleep and staying asleep, sleepiness, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UCB, Inc. at ucbCARES® (1-844-599-2273).

Please see additional Patient Information about the NEUPRO Patch. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

NEUPRO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people and is seen more frequently in people with asthma.

Patients treated with NEUPRO have reported somnolence and falling asleep without warning signs during activities of daily living, including driving, which sometimes resulted in accidents. Some patients believed they were alert immediately prior to the event. Patients may not recognize or acknowledge increased drowsiness or sleepiness. Therefore, prescribers should directly question patients about these possible occurrences and continually reassess patients, as some events have been reported well after the start of treatment. Patients should be advised to exercise caution while driving, operating heavy machinery, or working at heights during treatment with NEUPRO. If patients develop daytime sleepiness or episodes of falling asleep during activities of daily living, NEUPRO should be discontinued.

Patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic behavior during NEUPRO treatment or after starting or increasing the dose of NEUPRO.

NEUPRO may cause symptomatic postural/orthostatic hypotension. Patients treated with dopamine agonists require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk. NEUPRO may also cause syncope, elevated blood pressure, and elevated heart rate. These events should be considered when treating patients with cardiovascular disease or concomitant illness.

Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, and the inability to control these urges while taking medications, including NEUPRO, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease. Because patients may not recognize these behaviors as abnormal, prescribers should specifically ask patients and their caregivers about the development of new or increased urges while being treated with NEUPRO. Dose reduction or discontinuation of NEUPRO should be considered if such urges develop.

NEUPRO can cause application site reactions, and some may be severe. In clinical trials, most reactions were mild or moderate in intensity and were limited to the patch area.

Use of dopaminergic medications, including NEUPRO, may cause augmentation and rebound. NEUPRO should be removed before magnetic resonance imaging or cardioversion, because the aluminum backing layer in the patch could cause skin burns. Heat application has been shown to increase absorption several fold with other transdermal products. Therefore, patients should be advised to avoid exposing the application site to sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.

The most common adverse reactions (at least 5% greater than placebo) for NEUPRO in the treatment of Restless Legs Syndrome are application site reactions, nausea, disturbances in initiating and maintaining sleep, somnolence, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UCB, Inc. at ucbCARES® (1-844-599-2273).

Please see additional Patient Information about the NEUPRO Patch. This information does not take the place of talking with your healthcare provider about your condition or your treatment.