November 8, 2022

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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ⁱAllen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, Ferini-Strambi L. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med. 2005 Jun 13;165(11):1286-92. doi: 10.1001/archinte.165.11.1286. PMID: 15956009.
ⁱⁱSchormair B, Zhao C, Bell S, Tilch E, Salminen AV, Pütz B, Dauvilliers Y, Stefani A, Högl B, Poewe W, Kemlink D, Sonka K, Bachmann CG, Paulus W, Trenkwalder C, Oertel WH, Hornyak M, Teder-Laving M, Metspalu A, Hadjigeorgiou GM, Polo O, Fietze I, Ross OA, Wszolek Z, Butterworth AS, Soranzo N, Ouwehand WH, Roberts DJ, Danesh J, Allen RP, Earley CJ, Ondo WG, Xiong L, Montplaisir J, Gan-Or Z, Perola M, Vodicka P, Dina C, Franke A, Tittmann L, Stewart AFR, Shah SH, Gieger C, Peters A, Rouleau GA, Berger K, Oexle K, Di Angelantonio E, Hinds DA, Müller-Myhsok B, Winkelmann J; 23andMe Research Team; DESIR study group. Identification of novel risk loci for restless legs syndrome in genome-wide association studies in individuals of European ancestry: a meta-analysis. Lancet Neurol. 2017 Nov;16(11):898-907. doi: 10.1016/S1474-4422(17)30327-7. PMID: 29029846; PMCID: PMC5755468.
ⁱⁱⁱ https://www.rls.org/file/general-free-publications/RLS-ODYSSEY-II.Executive-Summary.5-30-2022.pdf. Accessed November 7, 2022.