Restless Legs Syndrome Foundation Blog

The 2022 CDC Opioid Prescribing Guidelines released on November 3, 2022, replace earlier guidelines that had led to confusion, misinterpretation, and faulty application by medical providers. Like the 2016 guidelines, the new guidelines focus on acute, subacute, and chronic pain.

Unfortunately, the new Guidelines fail to recognize that restless legs syndrome (RLS), a serious disease affecting millions of Americans, can only be relieved by daily small doses of opioids in many cases. This omission is surprising in light of the fact that the guidelines call out three medical conditions (sickle cell disease, cancer, or end-of-life care) that may require sustained doses of opioids. RLS, like these three conditions, should have an exemption from this Guideline.

RLS Foundation Board Member and Chair-Elect, Dr. Shalini Paruthi says, “RLS symptoms can occur anywhere along the spectrum from an urge to move the limbs to a painful sensation. RLS can be a chronic disorder for many people. Furthermore, patients with RLS face significant impacts on physical health, mental health, access to care and barriers to treatment. These health disparities disproportionately affect individuals with refractory RLS who require daily medical treatment. The RLS ODYSSEY II study found a four-fold risk for depression and suicidal ideation in patients with RLS, signifying the heavy burden of disease in this population.”

We are disappointed to learn that RLS was not included in the exemption of medical conditions, given the scientific validation of population prevalenceⁱ, strong genetic basisⁱⁱ and impacts on health-related quality of lifeⁱⁱⁱ.

RLS Foundation Scientific and Medical Advisory Board Chair, Dr. Christopher J. Earley says, “These guidelines have the potential to affect the 1 in 33 Americans with severe RLS who require daily medical treatment. Patients with moderate to severe RLS live every day with awareness of the burden of this disease; forever conscious of the limitations and barriers to appropriate and effective treatment.” Many RLS patients have experienced the negative consequences of the prior CDC Opioid Prescribing Guidelines as they find physicians and pharmacists unwilling to prescribe or supply the only medications that bring them relief. Without explicit mention of RLS in the new guidelines, they fear that federal and state agencies will use the revised guidelines to continue to deny them treatment.

The new guidelines are an improvement from those they replace, recognizing that no “one-size fits all approach” is appropriate and that provider clinical judgment is fundamental to making decisions on the use of opioids to manage pain.

The RLS Foundation and its Science and Medical Advisory Board will sharpen and clarify the recommendations to minimize their impact on long-term prescriptions of opioids to treat refractory RLS. In the interim, we urge members to report any problems they face in maintaining a relationship with their healthcare provider and/or obtaining prescription access to opioid therapy to manage refractory RLS. We ask that you provide your contact information and permission to use your experience to explain to policymakers the barriers facing the RLS community.

The RLS Foundation thanks the nearly 500 individuals that responded to the call to action during the public comment period on the proposed draft of the 2022 CDC Opioid Prescribing Guidelines. We are disappointed by the CDC’s lack of an exemption for RLS and plan to accelerate our advocacy efforts on Capitol Hill to ensure patients with refractory RLS have appropriate treatment access to opioid therapy. The RLS Foundation will continue to provide updates on our outreach activities and opportunities for you to voice your concerns with public officials in Washington, DC and at the CDC.

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RLS Community: Provide Your Comments to CDC by April 10

Background

The Centers for Disease Control and Prevention’s (CDC) National Center for Injury Prevention and Control is in the process of updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. The draft updated Clinical Practice Guideline for Prescribing Opioids is available for public comment in the Federal Register until April 10, 2022. The RLS Foundation urges all RLS community members to add their voice to request that the CDC include chronic diseases like RLS in the treatment guidelines. Below are the 5 steps you can take to let the CDC know that low-total-daily dose opioids must be included as a viable treatment option for RLS patients.

Instructions

1. Start on webpage: https://www.regulations.gov/document/CDC-2022-0024-0001/comment and click on "Comment"

2. Enter your comment using the sample comment below as a template.

3. Identify yourself as an individual, 4. Check the box for reCAPTCHA, and 5. Submit Comment.

Thank you for joining our RLS advocacy efforts by raising your voice for RLS, sleep and sleep disorders!

-----*SAMPLE COMMENT*-----

I thank you for revising the CDC Clinical Practice Opioid Prescribing Guideline, but the draft does not address chronic conditions like RLS that are different from chronic pain. Restless legs syndrome (RLS) is a chronic neurological disease that causes an urgent need to move the legs and, in some cases, other parts of the body as well. The symptoms make it impossible to sleep or even to sit quietly, which seriously affects every aspect of daily life.

In the U.S., nearly 12 million adults and children suffer from RLS. There is no cure. A few prescription medications may relieve the symptoms for a while, but over time those same medications can make the symptoms worse. When all other medical therapies fail, ample scientific research supports the use of low-total-daily-dose opioids to treat severe RLS.

[Tell your own experience with RLS in a short paragraph.]

The first physician to diagnose RLS more than 300 years ago treated it successfully with opioid therapy. Ironically, the 2016 CDC Opioid Prescribing Guidelines often made physicians afraid to prescribe opioids for any reason, even for patients with severe, unrelenting RLS who had been on the same low-total-daily-dose opioid therapy for decades. I urge the CDC to include a section in the 2022 Opioid Prescribing guidelines to address chronic medical conditions like RLS that require opioid therapy as a last resort, in low-total-daily doses, carefully monitored.

Thank you for your consideration of these vital issues, and please consider the RLS Foundation at www.rls.org as a resource for scientifically-based information about RLS, as it is for members like me.

Act NOW!

Add your comments by April 10 to be sure that the committee receives as many comments as possible from the RLS community. Please contact the RLS Foundation for assistance at info@rls.org.