Statement of Principles

The Opioid Crisis and Patient Access to Effective Therapy

About The Foundation The Restless Legs Syndrome (RLS) 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). Founded in 1989, the Foundation serves healthcare providers, researchers, 5500 members, and millions in the United States and around the world who have RLS. The RLS Foundation has members in every state, local support groups, and a research grant program that has awarded over $1.8 million to fund medical research on RLS causes and treatments.

Restless Legs Syndrome and Opioid-Based Therapy Restless legs syndrome (RLS) causes unpleasant or uncomfortable sensations in the legs together with an uncontrollable urge to move them. The National Institute of Neurological Disorders and Stroke (NINDS) describes RLS as a neurological sensory-motor disorder whose symptoms are produced within the brain. It is estimated that up to 5 to 7.5 percent of Americans may have RLS. There is currently no cure for this disease and any symptomatic relief achieved with medications is not guaranteed to work forever. Therefore, all potential treatment options that are known to be effective treatments for RLS, need to be available to the individual. Opioid medications in low-total daily doses are a recognized, effective treatment for managing RLS when alternative first-line medications do not work or become ineffective. Clinical studies and the experience of RLS-experts indicate that the average total-daily dose of opioids used to manage RLS is significantly lower than doses prescribed to treat chronic pain. Research has also demonstrated that utilization of these therapies to manage RLS does not show clinical indications of addiction or drug tolerance. Due to the devastating nature of RLS, if patients were to lose access to these therapies, they would also lose the ability to effectively manage their disease.

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.