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Treating a Restless Legs Sydnrome (RLS)

Last updated: July 2011

Restless legs syndrome (RLS) also known as leg jitters and sometimes mistaken for "growing pains" in children, can begin early in life and run in families. Or it can appear later and stem from an underlying condition. The symptoms can be mild or severe. Despite those variations, a diagnosis of RLS requires four essential features:

  • a strong urge to move your legs, often accompanied by unpleasant sensations you might describe as creeping, crawling, itching, pulling, tingling, burning or aching
  • symptoms that start or worsen when you're inactive
  • sensations that are relieved only by movement
  • symptoms that are worse in the evening, especially when you're lying down

Many people with RLS also experience repeated limb movements, or jerks, throughout the night, causing poor sleep, daytime fatigue. But first-line medication—including ropinirole (Requip) and pramipexole (Mirapex), which the Food and Drug Administration approved for the treatment of RLS—are sometimes unsuccessful because their effects can wear off over time or even worsen symptoms.

The FDA recently approved another medication, extended-release gabapentin (Horizant), to treat RLS. If those medications aren't effective, doctors might add or substitute other drugs "off-label," since they don't carry FDA approval, such as the anticonvulsant pregabalin (Lyrica), the antihypertensive medication clonidine (Catapres and generic), or various benzodiazepines. If those fail to provide relief, our medical consultants say opioid pain relievers such as codeine (Tylenol with codeine #3, generic), oxycodone (Percocet, generic), and methadone (Methadose, generic) could be tried next.

Opioids used for RLS are also prescribed off-label. (Doctors can legally prescribe any medication they deem appropriate to treat a condition.) An analysis of nearly 500 patients with RLS found that 23 percent had used opioids, some for an average of six years. The drugs might relieve the condition by triggering the release of dopamine, a natural substance in the brain that's needed to control movement. Opioids also block pain signals and have sedative effects that can improve sleep.

"The benefits are that they improve leg discomfort and twitching of the legs during the day and during sleep, particularly for people whose RLS is painful or secondary to nerve damage from diabetes or kidney failure," says Arthur S. Walters, M.D., a professor of neurology and associate director of sleep medicine at Vanderbilt University in Nashville, Tenn. "But patients who use them should be monitored for the development of sleep apnea, or breathing problems during sleep. And they should be aware that these are addicting medications and be monitored for that, even though the rate of addiction in RLS patients is quite low."

Related: Off-label use of clonidine. Is it really a wonder drug?

What is the evidence?

Little research has addressed that question, even though opioids have been used to treat RLS since the 17th century. In a placebo-controlled trial, oxycodone reduced leg sensations, restlessness, and limb movements during sleep, improving sleep quality and daytime alertness. In another study of 36 people with RLS, some patients who used opioids showed an improvement in leg symptoms and sleep, with one case of physical dependence on the drug and three patients with new or worsening sleep apnea. In a study of 27 RLS patients who tried methadone after not finding relief with other medications, 17 remained on the drug for an average of about two years and reported at least a 75 percent reduction in symptoms.

But those studies were small, and two of them lacked objective evidence of symptom relief. Guidelines from the European Federation of Neurological Societies considers oxycodone "probably effective" for the type of RLS that's inherited. The guidelines note that side effects were mild and addiction rare. The authors did not find enough evidence to recommend other opioids for RLS.

What are the risks and warnings?

Slowed breathing. Because of this serious side effect, people with respiratory problems should use opioids with extreme caution, if at all.

Sedation and other effects on the nervous system. These might include dizziness, visual disturbances, agitation, seizures, mental clouding, depression, euphoria and other reactions. People who do hazardous tasks requiring mental alertness or physical coordination, including driving, should be mindful of these effects.

Decreased sex hormones. Long-term use can result in a loss of libido and difficulty achieving orgasm.

Constipation. This can be reduced with the use of laxatives, stool softeners, an increased intake of dietary fiber and fluids, and increased physical activity.

Birth defects. Pregnancy often triggers RLS, and some experts recommend opioids to prevent the accompanying sleep disruption, which can lead to premature or difficult delivery. But babies whose mothers took opioids just before or early in pregnancy had an increased but modest risk of birth defects, according to a 2011 study by the Centers for Disease Control and Prevention.

Tolerance and dependence. You might need increasing amounts of the medication or experience withdrawal symptoms if you discontinue the drug abruptly. Addiction is more likely in people with a history of drug or alcohol abuse. Your doctor should assess you for substance abuse or dependency before prescribing an opioid, and monitor you during treatment.

Other side effects. They include nausea, vomiting, itching, difficulty urinating, and increased pain sensitivity. Some RLS studies have reported new or worsening sleep apnea with long-term use.

Drug interactions. Don't mix opioids with alcohol, antihistamines, sedatives, tranquilizers, or certain antidepressants.

What steps should you try first?

Treat underlying causes. Your doctor should check you for iron deficiency, kidney failure, diabetes, Parkinson's disease, and rheumatoid arthritis. "Iron levels are universally low in RLS," Walters says. Our medical consultants say that all patients with low iron levels—below 50 ng/mL as measured by your ferritin levels, an indirect way of measuring the iron levels in your blood—should receive supplemental iron therapy.

Review your medications. Drugs that can cause or worsen RLS include beta-blockers, calcium-channel blockers, cold and allergy medicines containing antihistamines, sleep medications or diphenhydramine (such as Tylenol PM, Benadryl, and generics), antidepressants, antinausea medicines, and antipsychotics.

Make lifestyle changes. Avoid alcohol, cigarettes and caffeine; do daily moderate exercise, notably walking and stretching; take a hot or cold bath; massage the affected limb(s) or use heat or ice packs; occupy your mind when you have to stay seated, perhaps with needlework or video games; distract yourself with a crossword puzzle or other mentally challenging activity before bedtime; use breathing and relaxation techniques to fall asleep; and adopt good sleep habits, such as going to bed and waking up at the same time every day.

Get support. Find a group in your area through the RLS Foundation.

Consider a first-line medication. They can include approved medication—extended-release gabapentin (Horizant), pramipexole (Mirapex), or ropinirole (Requip). And certain drugs for Parkinson's disease can also quiet restless legs. Other medication, including gabapentin (Neurontin, and generic), pregabalin (Lyrica), clonidine (Catapres and generic), and various benzodiazepines might be helpful.

Bottom line. Although evidence for their use is minimal, opioid pain relievers have a long history of usefulness for some patients with RLS. Our advice: Talk with your doctor about underlying causes and all available treatments for RLS. If first-line medications aren't effective or you can't tolerate them, consider the use of opioids only after their risks and benefits have been thoroughly explained to you.

This off-label drug use report is made possible through a collaboration between Consumer Reports Best Buy Drugs and the American Society of Health-System Pharmacists. This is the 26th in a series based on professional reports prepared by ASHP.

These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

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