Statement of Principles

The Opioid Crisis and Patient Access to Effective Therapy

About The Foundation The Restless Legs Syndrome Foundation is a 501(c)(3) nonprofit organization dedicated to improving the lives of men, women and children who live with restless legs syndrome (RLS), an often-devastating disease. Founded in 1989, the Foundation’s goals are to increase awareness, improve treatments and, through research, find a cure for RLS. The Foundation serves healthcare providers, researchers, 5,600 members, and millions of people in the U.S. and around the world who have RLS. The RLS Foundation has members in every state, local and virtual support groups, and a research grant program that has awarded nearly $2 million to fund medical research into the causes and cures for RLS.

Restless Legs Syndrome and Opioid-Based Therapy RLS is a serious neurological disease that devastates the lives of millions of Americans. An estimated 12 million men, women and children in the U.S. have RLS. One in 33 adults (3%) needs daily clinical treatment. There is no cure; treatment is life-long. People with RLS experience an overwhelming, agitating, and uncontrollable urge to move their legs, which is only relieved by moving or walking. RLS is at its strongest in the evening and at night, severely disrupting sleep. It is 3 to 4 times more common in women than men, and twice as common in elderly Americans.

The sleep loss caused by RLS robs people of the ability to work and live normally, and may lead to depression, anxiety and suicidal thoughts. The RLS Foundation loses members every year to suicide because their symptoms become unbearable. Profound sleep loss puts people with RLS at risk for hypertension, diabetes, heart attack, stroke and Alzheimer’s disease.

RLS treatment options are limited; FDA-approved RLS treatments do not provide life-long coverage. First-line medications don’t work for some patients, and over time actually make the disease worse for many others due to a serious side effect known as augmentation.

For the millions of people who have chronic, unrelenting, nightly RLS symptoms, opioids are an established, highly effective treatment option when first-line therapies have failed. Opioids, taken in low-total daily doses, bring dramatic relief to an estimated 90% to 95% of RLS patients.

It’s important to note that RLS is not chronic pain; it has a distinctly different underlying neuropathology. RLS is a neurological disease impacting sleep and is best managed by neurologists and sleep specialists. Clinical experience among experts who treat severe RLS with opioids has not shown the degree of drug misuse, dependency or addiction that is commonly associated with opioid treatment for chronic pain. RLS expert experience also indicates that the dose of opioids used to manage RLS is significantly lower than that used to treat chronic pain effectively. Evidence-based clinical guidelines, published in two seminal Mayo Clinic Proceedings articles, outline for clinicians’ recommendations for RLS treatment, management and the appropriate use of opioids in refractory RLS.

Key Issues for Policymakers:

  • RLS is a neurologically-based sleep disorder, and therefore, management should not fall under the exclusive purview of pain-management specialists when opioids are indicated. The underlying neuropathology in RLS is quite different from that associated with chronic pain. Therefore, long-term outcomes for opioid use in RLS should not be extrapolated from their use in chronic pain.
  • The total daily dose of opiates commonly used to treat RLS is often lower than that used in managing chronic pain, which dramatically reduces the risk of tolerance and dependency.
  • RLS patients and their physicians need assurance that regulations designed to curb abuse of opiates do not inadvertently penalize patients suffering from a serious disease who have exhausted other treatments. Regulations that seek to limit refills, require frequent doctors’ visits and co-payments, or erect other barriers can have a devastating effect on RLS patients with no countervailing public health or safety benefit.
  • Any legislation, policy, or regulation must account for the specific needs of RLS patients and not paint them with the same broad brush as other communities utilizing (and often struggling with) opioid-based treatments.

Read our legislative and policy priorities.