Newly published guidelines outline how to safely use opioids in treating and managing RLS that doesn’t respond to traditional therapies.

Refractory restless legs syndrome (RLS)—that is, RLS that’s unresponsive to traditional therapies or in which the patients can’t tolerate traditional therapies—can be frustrating for clinicians and patients alike. Opioids can be a viable therapy for these patients— and a paper published in the January issue of Mayo Clinic Proceedings aims to illuminate this treatment pathway.

“We’ve known for many years there is a percentage of patients with chronic restless legs who are refractory to other treatments, like dopamine agonists and alpha-2-delta ligands and a significant percentage of these patients benefit from opioids,” says Michael Silber, MB, ChB, professor of neurology at the Mayo Clinic College of Medicine and Science and an author of the new guidelines. “The drugs have been studied for a while and in low doses are highly effective to manage restless legs.”

At a time of heightened concern about opioid abuse, the Restless Legs Syndrome Foundation scientific and medical advisory board recently put a task force together, which Silber chaired, to look at the use of opioids in RLS and produce a paper for the benefit of primary care providers and specialists in the reasonable, appropriate use of the drugs. “We wrote it in hopes of educating providers on how these drugs are necessary and can be used safely after taking all precautions first,” Silber says.

These precautions, according to Silber, are:

  1. Try other drugs first like the dopamine agonists and alpha-2-delta ligands. Try strategies to improve response to other medications and consider alternative and combination therapies.
  2. Look for other factors that can worsen restless legs, such as low iron, and address those first.
  3. Assess for risk of addiction and educate patients on responsible use.
  4. Start with the lowest dose of opioids possible and monitor patients over time for effective and safe use.

“When one starts a patient on opioids, one needs to explain to the patient how the treatment will work and sign an ‘opioid contract,’” says Silber. “The conditions of the contract include: a patient understanding of side effects, medications will be obtained from a single provider and a single pharmacy, the provider will not issue repeat prescriptions, the patient will not increase the dose without consulting the provider, and the drugs will not be shared with anyone else.”

Silber adds that providers should always do a urine drug screen at the start of treatment and at ongoing regular intervals. “We also consult the state databases of drug prescription to be sure the patient is obtaining opioids from one provider only, and we follow the patient regularly,” he says.

These precautions and conditions do not come without reason. Given the national opioid crisis, it is understandable that providers are hesitant to prescribe them. But Silber emphasizes there is a way to use opioids appropriately, and providers should separate their RLS patients from chronic pain patients. “We’re extremely cognizant of the opioid epidemic in this country and how for chronic pain opioids have been increasingly prescribed over years,” he says. “But our patients with RLS are very different. First, it’s a completely different mechanism from chronic pain—they are not the same thing. Second, the doses we use for restless legs are far lower than those used for chronic pain, maybe about a quarter of the doses or less.

“The pendulum has swung back and forth when it comes to opioid use. When I was in school, we were taught never to use opioids to treat chronic pain. Then, the concept came into medicine that patients had a right to be relieved of their pain, so physicians started prescribing opioids for it. We now know that opioids don’t work well for chronic pain and do lead to dependence, especially in the high doses used. Now, with this incredible epidemic of opioid misuse in the country and the frighteningly high rate of overdose death, the pendulum has swung the other way.”

And in certain respects, like with that of RLS, it has seemingly swung too far. The patients that could benefit from opioids are finding it hard to get them, and physicians are worried about writing any opioid prescriptions.

Nevertheless, through the Mayo Clinic Proceedings paper, Silber hopes to instill a sense of confidence in physicians to start prescribing opioids to refractory RLS patients who can use them safely and responsibly. He says, “If you follow the rules and do the right thing, you and the patient are at no risk.”

Dillon Stickle is associate editor of Sleep Review.