Restless Legs Syndrome Foundation Blog

March 30, 2021

"Congressional Sign On Letter" for Sleep Disorder Research, Education and Awareness

Background

For the third year in a row, an official Congressional Sign On Letter will be sent to the Appropriations Committee asking them to prioritize support for sleep and sleep disorders research and awareness. To be effective, we need your member of the U.S. House of Representatives to "sign on."

Urgent Deadline Approaching

Your Congress Person will only join if YOU (the constituent) ask, and the final deadline is April 8. Take action TODAY, it is imperative! Here’s how:

1. Provide us with your name, address and email here. Include your Representative's name - go to www.house.gov and enter your zip code in "Lookup" to confirm your current member of House of Representatives.
2. Within 24 hours we will return text that you can copy and paste into an email (sample below) along with the email address for the staffer that handles healthcare for your district.
3. Insert staffer's email, cc: clara@rls.org and Press SEND!

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

-----*SAMPLE PERSONALIZED REQUEST EMAIL*-----

To: [first.last]@mail.house.gov
Cc: clara@rls.org
Subject: Sign On Letter – Sleep Community

Dear [Staffer],

My name is [Your Name] and I am a constituent from [City, State]. I am also an advocate for the RLS and sleep disorders patient community. I hope your office will join the attached sign on letter, which supports the community’s appropriations recommendations for FY 2022. To join this letter, please contact Heather Connelly at heather.connelly@mail.house.gov by April 8.

Thank you for your time and for considering this request.

Sincerely,
[Your Name]
[Your Address]
[City, State Zip]

ATTACHMENT: FY22 Sleep Disorders DC and Sign on Letter

Act NOW! Send us your request by April 5!

Please submit your information now, you will receive a personalized email to send to the appropriate health staffer within 24 hours. All requests must arrive before April 5 to meet the email deadline of April 8.

JULY 15, 2018

Contact the Food and Drug Administration (FDA) and ask them to maintain access to opioids in low total daily doses for patients with refractory RLS

Decision makers at the FDA are requesting comments by September 10, 2018 from patients who utilize opioid therapies to manage their chronic conditions. Agency officials want to hear from refractory RLS patients on how they manage their condition and barriers that are affecting their access to treatment.

Background

On Monday, July 9th, the Restless Legs Syndrome (RLS) Foundation participated in a Patient Focused Drug Development (PFDD) meeting hosted by the FDA. The goal of this meeting was to incorporate patients’ voices as the agency develops guidance on opioid therapies for chronic pain, refractory RLS, and other conditions that utilize these treatments.

RLS is not considered to be a chronic pain condition, because its underlying mechanisms and neuropathology are very different. The Foundation urged regulators to appreciate the differences. This is why it’s important for the RLS community to take part in these discussions, because the perspectives shared will inform the FDA’s decision making on regulations that will affect refractory RLS patients who utilize low total daily doses of opioids to manage their condition.

At the July meeting the FDA welcomed input from a variety of people using opioids to manage chronic conditions. The FDA is now seeking input from patients who were unable to attend in person. Written comments will add weight and depth to the presentations made at the meeting.

Given the high level of concern about opioid related deaths, it is critical that RLS patients make their voices heard at this crucial moment in the policymaking process! In response to these questions, always make sure to note that RLS is different from chronic pain and requires any regulations or legislation take this difference into account. Now is your chance to speak up, to share your experiences and frustrations.

Take Action

• Go to the FDA’s online portal for submitting electronic comments to submit feedback at https://www.regulations.gov/document?D=FDA-2018-N-1621-0001 and click on “Comment Now” at the right of the page. 

• Tell the FDA about RLS, how you manage your symptoms, and what kind of barriers have affected your access to treatment. You can use the suggested discussion topics below to inform your comments.

Feel free to answer the questions directly or simply review them to help guide your response:

Topic 1: Symptoms and Daily Impacts

1. How would you describe your RLS symptoms? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)
2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)
3. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
4. How has your condition changed over time? (Considerations include severity and frequency of symptoms and the effects of RLS on your daily activities.)

Topic 2: Patients' Perspectives on Current Approaches to Treatment

1. What are you currently doing to help treat your RLS? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)
a. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)
b. What factors do you take into account when making decisions about selecting a course of treatment?
2. How well does your current treatment regimen manage your chronic condition?
3. What are the most significant downsides to your current treatments, and how do they affect your daily life?
4. What challenges or barriers to accessing or using medical treatments have you or do you encounter?

Electronic comments must be submitted on or before September 10, 2018. Make sure to let the RLS Foundation know you participated in this campaign!

References

(1) Spence D. Bad medicine: Restless Legs Syndrome. BMJ 2013; 347: 17615.

(2) Allen 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; 165: 1286-92.

(3) Manconi M, Fulda S. Restless legs syndrome in the emergency room. Eur J Neurol. 2013 Feb;20(2):e36. doi: 10.1111/ene.12035. PubMed PMID: 23311509.

(4) International Restless Legs Syndrome Study Group, 2012 revised diagnostic criteria. http://irlssg.org/diagnostic-criteria/ Accessed September 12, 2013.

(5) Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. The participants in the Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health in collaboration with members of the International Restless Legs Syndrome Study Group. Restless Legs Syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the Restless Legs Syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Medicine 2003; 4: 101-119.

(6) Trenkwalder C, Hogl B, Winkelmann J. Recent advances in the diagnosis, genetics and treatment of restless legs syndrome. J. Neurol 2009; 256: 539-53.

(7) Winkelmann J, Schormair B, Lichtner P, Ripke S, Xiong L, Jalilzadesh S et al. Genome-wed association study of Restless legs Syndrome identifies common variants in three genomic regions. Nat Genet 2007; 39: 1000-6.

(8) Stefansson H, Rye DB, Hicks A, Petursson H, Ingason A, Thorgeirsson TE et al. A genetic rsik factor for periodic limb movements in sleep. N Engl J Med 2007; 357:639-47.

(9) Connor JR, Wang XS, Allen RP, Beard JL, Wiesinger JA, Felt BT et al. Altered dopaminergic profile in the putamen and substantia nigra in Restless Legs Syndrome. Brain 2009; 132: 2403-12.

(10) Early CJ, Connor JR, Beard JL, Malecki EA, Epstein DK, Allen RP. Abnormalities in CSF concentrations of ferritin and transferring in Restless Legs Syndrome. Neurology 2000; 54: 1698-700.

(11) Allen RP, Barker PB, Wehrl F, Song HK, Earley CJ. MRI measurement of brain iron in patients with Restless Legs Syndrome. Neurology 2001; 56: 263-66.

(12) Connor JR, Boyer PJ, Menzies SL, Dellinger B, Allen RP Ondo WG et al. Neuropathological examination suggests impaired brain iron acquisition in Restless Legs Syndrome. Neurology 2003; 61: 304-9.

(13) Allen RP, Barker PB, Horska A, Earley CJ. Thalamic glutamate/glutamine in Restless Legs Syndrome: Increased and related to disturbed sleep. Neurology 2013; 80: 2028-34.

(14) Walters AS, Ondo WG, Zhu W, Le W. Does the endogenous opiate system play a role in the Restless Legs Syndrome? A pilot post-morten study. J Neurol Sci 2009; 279: 62-5.

(15) Patton SM, Cho YW, Clardy TW, Allen RP, Earley CJ, Connor JR. Proteomic analysis of the cerebrospinal fluid of patients with Restless Legs Syndrome/Will-Ekbom Disease. Fluids Barriers CNS 2013 Jun 7;10(1):20. doi: 10.1186/2045-8118-10-20.

(16) The International Classification of Sleep Disorders. Diagnostic and Coding Manual. Second Edition. The American Academy of Sleep Medicine. Westchester, Ill., pp. 1-297, 2005.

(17) Ferini-Strambi L, Walters AS, Sica D. The relationship among Restless Legs Syndrome (Willis Ekbom Disease), hypertension, cardiovascular disease, and cerebrovascular disease. J Neurol DOI 10:1007/s00415-013-7065-1 (Published Online August 21, 2013).

(18) Li Y, Wang W, Winkelman JW, Malhotra A, Ma J, Gao X. Prospective study of Restless Legs Syndrome and mortality among men. Neurology 2013; 81: 52-9.

(19) [Goetz CG, Wu J, McDermott MP, Adler CH, Fahn S, Freed CR, et al. Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. Mov Disord 2008;23(5):690-9.

(20) Macedo A, Banos JE, Farre M. Placebo response in the prophylaxis of migraine: a meta-analysis. Eur J Pain. 2008;12(1):68-75]

(21) Lidstone SC, Schulzer M, Dinelle K, Mak E, Sossi V, Ruth TJ, et al. Effects of expectation on placebo-induced dopamine release in Parkinson disease. Archives of general psychiatry. 2010;67(8):857-65.

(22) Willis T. The London practice of physick. London,: Basset and Crook; 1685.

(23) Ekbom KA. Restless legs. Acta Med Scand. 1945;Suppl 158:1-123.