Restless Legs Syndrome Foundation Blog

The ‘Opioid Issue’ Still Needs Your Attention

Five years ago, we wrote in NightWalkers about the challenges that people with RLS and their doctors face in getting opioid prescriptions filled. In recognition of the seriousness of the problem experienced by many of our members, we retained the services of a public affairs firm in Washington that specializes in healthcare issues to help us alert policymakers about the problem and to craft sensible federal policies that recognize the unique role these medications play in providing relief for many among us.

In response to concerns about opioid addiction, the Foundation has funded groundbreaking research that documents the long-term safety and efficacy of opioids as a treatment for severe RLS.

Over the intervening years, we have deployed Foundation staff, members of our Scientific and Medical Advisory Board, and individual Foundation members to visit members of Congress, federal agencies, and others making or influencing policy, legislation or regulation on this topic.

Nevertheless, those who write the guidelines and rules about dispensing opioids continue to get it wrong: They craft guidelines appropriate for treatment of chronic pain that lack recognition of the unique neuropathology of RLS and the specialized consideration required in treating RLS, but rather include RLS in the category of generalized pain issues.

Documentation can be found in medical literature as far back as four centuries ago about the safety and efficacy of low total daily doses of opioids to treat people with severe RLS that has failed to respond to other treatments. This so-called “off-label” use is relatively common when physicians discover that drugs can alleviate conditions beyond those specifically approved by the government. (For example, a medication approved for high blood pressure is frequently prescribed to musicians to prevent performance anxiety.) To obtain approval “on label,” the government requires extensive, costly years of testing.

Pharmaceutical companies are unwilling to invest in such lengthy trials, particularly in the case of drugs like common opioids that cannot be patented. With no hope of recapturing the costs of testing a drug, no company will undertake the licensing process.

To be sure, there are approved drugs that are useful in treating RLS symptoms. These include alpha-2-delta ligands (gabapentin-type drugs, originally developed to treat seizure disorders and nerve pain), iron infusion, and dopaminergic drugs such as pramipexole, ropinirole, rotigotine and levodopa/carbidopa.

Unfortunately, experience has shown that while dopamine agents improve symptoms over the short term, over time, they can make RLS worse. This is an untoward effect of dopamine therapy known as augmentation, in which the medication prescribed to treat RLS symptoms actually makes the disease worse over months or years. Thus, dopamine drugs are no longer favored for long-term use.

When all other options have failed, as they do for many people with RLS, there is only one remaining treatment available: opioids.

The Centers for Disease Control and Prevention (CDC) has recently published a revised guideline for the use of opioids to treat chronic pain. The new rules are similar in many respects to prior versions, except that they reduce the maximum recommended daily dose of opioids to an even lower level than before.

Available information indicates that three-fourths of RLS patients using opioids are prescribed doses below these new CDC guidance levels. Alarmingly, this means that about one-fourth of patients receiving opioids are at risk of losing access to the only effective treatment for their disease.

It appears that the new guidelines ignore well-established scientific evidence that RLS is different from chronic pain and needs to be treated differently. Consider the following facts:

• In contrast to chronic pain, where opioids lose their effectiveness over time, when used to treat RLS, the drugs continue to provide relief from RLS symptoms for years, even decades.
• When prescribed for chronic pain, patients must increase doses over time to achieve relief. In contrast, The RLS Opioid Registry, a longitudinal study conducted at Massachusetts General Hospital, has found RLS patients remain at low total daily doses for decades; no increases are required to sustain relief.
• RLS patients typically do not develop opioid use disorder or develop issues of tolerance or dependence. Research and expert opinion have found that the low total daily doses used to manage severe RLS do not lead to tolerance or dependency issues, which are hallmarks of opioid use disorder.

To be fair, the revised CDC guideline recognizes that it is only advisory, not mandatory. “This clinical practice guideline provides recommendations but does not replace clinical judgment and individualized, patient-centered decision-making.”

Unfortunately, experience demonstrates that such language is widely ignored. Suggestions are transmuted into hard and fast rules. The Foundation receives reports from members and physicians that state regulators have converted this guideline into rigid regulations, insurance companies have refused to provide coverage for opioids even when within the recommended limits, pharmacies have refused to fill legal and proper prescriptions for opioids for RLS, hospital emergency rooms have treated patients using opioids for RLS control as if they were addicts and criminal drug dealers, and some doctors, clinical practices and medical centers have stopped prescribing opioids at all treat RLS. Even worse is the letter patients receive that their physician no longer treats RLS and they will need to find a new provider. These reactions are driven by fear, not science.

It is notable that the new guideline acknowledges that the general advice the CDC provides on opioids specifically does not apply to three situations: patients with sickle cell anemia, cancer patients with pain, and palliative care (end-of-life) treatments. We believe that the CDC needs to add RLS to the list of medical conditions that lie outside of its recommendations for the treatment of chronic pain.

How is the Foundation responding to this challenge facing its members? We have already held conversations with the leadership at the CDC. We note that:

• RLS is a distinct neurological condition that responds differently to opioids than chronic pain.
• RLS is a very significant disorder with a greater disruption in health-related quality of life than many other recognized medical conditions.
• There is a four times greater risk of suicide among those with severe RLS than in the general population, and twice the risk than that of people with severe chronic pain.
• There is strong evidence that using opioids to treat RLS does not lead to tolerance or dependence on opioids.
• Most of the drugs approved by the Food and Drug Administration to treat RLS (Requip, Mirapex and Neupro) actually make the condition worse over time, and the remaining approved drug (Horizant) is either not tolerated or is not fully effective in a large percentage of people with severe RLS.
• The CDC should specifically exempt RLS from the guideline for opioid prescribing in the same way that it has exempted sickle cell disease. Like sickle cell disease, RLS is a disease with a genetic predisposition.

The RLS Foundation hopes that the CDC will respond to these arguments. If it does not, we expect that we will need to carry the same discussion to other venues that are involved in the process, up to and including the United States Congress.

We will keep members of the RLS Foundation advised of our progress. It is possible that we will ask members to add their voices to the more than 500 members of the Foundation who have already submitted comments to the CDC during the public comment period preceding the issuance of the new opioid guideline (more than 10% of all comments listed). Although we did not achieve the hoped-for goal in that process, it is clear that there is more work to be done. Please be alert to calls for action.

Our efforts to fight for the rights of those with RLS to obtain the medical treatment they need and deserve, without undue restrictions, are ongoing. The RLS Foundation is a volunteer-driven organization, and we appreciate your continued financial support to increase our advocacy efforts. For more information on how you can get involved, go to www.rls.org/advocacy.

Help! I Think I Have Augmentation and Don’t Know What to Do!

Each day at the RLS Foundation we receive calls from individuals seeking support, information and help with augmentation, a distressing challenge to their RLS treatment.

The good news is that, thanks to ongoing research, augmentation is manageable and treatment options are available. This article provides an overview of augmentation that will help you to understand this unfortunate side effect of treatment and the available strategies to manage it.

What is Augmentation?

Augmentation is a worsening of RLS symptoms that occurs after starting a medication that increases dopamine levels in the brain. These dopaminergic medications include levodopa/carbidopa, ropinirole, pramipexole and the rotigotine patch. At first, medications in this category are very effective, but over time, in a period from six months to several years, RLS symptoms worsen from what they were prior to initiating therapy. The rate of augmentation in people taking dopamine drugs for RLS is 5%- 10% per year; in eight years nearly half of individuals taking dopaminergic medication will experience augmentation.

If an individual with RLS notices symptoms progressively worsening after starting treatment with a dopaminergic drug, then augmentation may be occurring. Simply put, the treatment initially prescribed to alleviate symptoms is worsening the disease.

What are the Symptoms of Augmentation?

Augmentation is an insidious process, and symptoms often go unnoticed. The first indication of an underlying problem is when a patient feels the need to request an increase in medication dose.

All individuals with RLS should recognize the symptoms of augmentation, which include:

• Earlier onset of symptoms, beginning in the afternoon and evening, rather than at bedtime
• Increase in the intensity of symptoms compared to their level prior to starting treatment
• Spread of symptoms to other body parts (trunk, arms or face), rather than being limited solely to the legs
• Shorter period of rest or inactivity before symptoms begin, and treatment medication is not working as long as it did previously
• Loss of effectiveness of the medication at the dose that previously managed symptoms
• Paradoxical response to the medication; in other words, the prescribed medication triggers symptoms rather than alleviating them

Three factors predispose an individual with RLS to developing augmentation:

• Daily administration of carbidopa/levodopa to treat RLS
• Exceeding the maximum dosages approved by the Food and Drug Administration (FDA) for dopaminergic drugs used to treat RLS
• Low body iron stores as measured by a laboratory test of serum ferritin

When someone is experiencing augmentation, aggressive iron supplementation is extremely important. Intravenous formulations effective in raising blood iron storage levels in RLS patients include: Ferumoxytol (Feraheme); low molecular iron dextran (INFeD); ferric derisomaltose (Monoferric) and ferric carboxymaltose (Injectafer). Ferrous sulfate 365 mg pills taken once daily can be used for ferritin levels higher than 75–100 mcg/L or transferrin saturation less than 20%. However, RLS patients with deteriorating symptoms need rapid iron repletion, and oral iron takes months to improve iron status.

If you, as a patient, suspect augmentation, the first course of action is to make an appointment with your healthcare provider; do not stop taking the medications, as prescribed, to manage your RLS.

How is Augmentation Diagnosed?

Before a diagnosis of augmentation can be made, the first step is to schedule an appointment with your RLS healthcare provider for a thorough medical examination to rule out any underlying medical conditions that can exacerbate RLS symptoms. Two additional aspects of RLS that are often confused with augmentation are night-to-night variability of symptoms and exacerbation of symptoms for several days; neither is indicative of augmentation.

Factors that can worsen RLS include the use of sedating antihistamines; all antidepressants except for bupropion or trazadone; low body iron stores or unexpected blood loss due to surgery or undiagnosed gastrointestinal bleeding (ulcers, polyps); commonly reported triggers of symptoms such as caffeine, alcohol, sugar, salt or nicotine; a secondary undiagnosed sleep disorder such as sleep apnea; or rebound (the prescribed medication is not lasting as long as it did previously and disrupts sleep at the end of the sleep cycle in the early morning hours). Two additional factors that can cause an increase in RLS symptoms are stress and changes in activity level, such as immobility due to surgery or changes in exercise, activity or routines.

Augmentation Diagnosis: What’s Next?

RLS is a chronic progressive disease, and it is often difficult to distinguish between disease progression (natural worsening of the disease) and augmentation. Healthcare providers need to be aware of the key indicators of augmentation, which include:

• The patient requests a dose increase of a dopaminergic medication.
• The prescribed dose currently exceeds FDA maximums for the dopaminergic medication.
• The patient reports breakthrough RLS symptoms with an accompanying increase in symptom intensity.
• The RLS involves other body parts (trunk, arms, face).
• Symptoms occur 24/7.
• Symptoms previously appearing only in the evening or nighttime now present earlier in the day, and the patient requests additional medication doses earlier in the day.

There is no test for the diagnosis of RLS augmentation. A thorough medical examination by your healthcare provider who reviews current medications (over-the-counter medications, supplements, prescriptions) to look for drugs that can worsen RLS symptoms, along with a comprehensive history of symptom progression, will help to determine if augmentation is present.

How is Augmentation Managed?

There are four treatment strategies to manage RLS augmentation. Working with your doctor you can determine the approach that best works for you.

The first approach involves changing the dosing schedule to “split-dose” the dopaminergic medication. Half the dose of the medication is given earlier in the day, and the second half is given at the regularly scheduled time; the total dose is not to exceed FDA maximums. If this approach does not resolve symptoms, a second medication from another medication class is added to the treatment regimen. Alpha-2-delta ligand drugs such as gabapentin, gabapentin enacarbil, and pregabalin are added to the treatment plan while reducing the dose of the dopaminergic agent. This approach may be effective, but the alpha-2-delta ligands may not be sufficient to control RLS symptoms in the absence of the dopaminergic agents.

A second treatment option to manage augmentation is to switch from a short-acting dopamine agonist to a long-acting one, but this approach is not recommended by RLS experts. The FDA approved the Neupro (rotigotine) patch for the treatment of RLS, and the oral medications pramipexole ER and ropinirole XL are also available. There are no studies to determine if the change to a long-acting dopamine agonist will reduce or mask RLS symptoms. RLS experts have found that tapering off long- acting dopamine agonists with preexisting augmentation is considerably more difficult. Although symptoms improve in the short term, the underlying augmentation remains, and in time symptoms will return.

The third approach involves adding an opioid medication such as buprenorphine, suboxone, methadone or oxycodone to the dopamine agonist, then tapering down the dopamine agonist. Once the transition from dopamine agonist to opioids has occurred, the dose of the opioid is reduced. If symptoms persist, an alpha-2-delta ligand can be added to the treatment protocol, or it can be used to decrease the dose of opioid used.

The final approach to address augmentation is to slowly decrease the dose of the dopamine medication, without any other RLS treatment, followed by 12 drug-free nights before reassessing the need for further treatment. The RLS Foundation handout Drug Holidays and RLS provides a thorough outline of this approach to the treatment of augmentation.

For patients with severe augmentation who have taken high dopamine medication doses, it may be difficult to completely eliminate these drugs, due to the worsening of RLS upon withdrawal. A small dose of a dopamine drug in combination with an alpha-2-delta ligand and/or opioid may be necessary to manage symptoms. However, it is important to note that, once a dopamine drug is successfully discontinued, reintroducing any drug in the dopamine class will lead to a rapid reappearance of augmentation. In other words, all drugs in the dopamine class are no longer a treatment option.

How Do I Find a Provider to Manage RLS Augmentation?

A provider who is knowledgeable and experienced in treating RLS can be found at an RLS Foundation Quality Care Center. The doctors who practice at these centers are certified RLS providers who treat patients with augmentation and are familiar with the available treatment options. There are 10 RLS Foundation Quality Care Centers in the United States and two in Europe; travel to receive expert care is an option available to individuals with RLS, though not all patients can afford to do so. For a list of RLS Foundation Quality Care Centers, visit www.rls.org/QCC or contact the Foundation.

A second option is to work with the healthcare provider managing your RLS treatment. You will want to determine that they have experience in managing augmentation and are willing to work with you through the entire process. Finding a treatment plan to manage your RLS augmentation is not a one- size-fits-all approach, so finding a provider who is willing to work with you is essential.

The RLS Foundation maintains a list of providers who have expressed an interest in treating RLS, and this may be an option for you. To view this list, visit www.rls.org/Find-a-doc or contact the Foundation. However, these healthcare providers are not certified RLS experts like those practicing at an RLS Quality Care Center.

I Think I Have Augmentation. What Can I Do to Help Myself?

You can do several things before an appointment with your healthcare provider that will give them insight into the state of your RLS. Below is a helpful checklist of items to prepare you for your appointment:

1. Resist the urge to make any changes to your current treatment plan. Your healthcare provider needs to get a clear picture of your RLS symptoms under your current treatment plan; any changes could make this more difficult.
2. Schedule an appointment with your healthcare provider as soon as possible. Because scheduling delays are common, ask whether your name can be added to a cancellation list when you book your appointment. That way, if there is a cancellation, you may be called to fill the slot in the schedule.
3. Make a list of all medications that you currently take (prescriptions, over-the-counter medications, supplements).
4. Make a chronological list of all medications that you have taken in the past for RLS and note why you stopped taking them.
5. Gather copies of all laboratory test results for iron, and any other recent laboratory test results for your provider to review.
6. Complete an RLS Sleep Diary, included in this issue of NightWalkers. The Sleep Diary will provide your healthcare provider with an overview of your sleep patterns and RLS symptoms.
7. Make and bring copies of the following open-access articles from Mayo Clinic Proceedings: “The Management of Restless Legs Syndrome: An Updated Algorithm” (2021) and “The Appropriate Use of Opioids in the Treatment of Refractory Restless Legs Syndrome” (2018). For copies of these articles, visit www.mayoclinicproceedings.org or contact the Foundation.

For more information about augmentation and RLS, visit the RLS Foundation’s Member Portal on www.rls.org to find educational resource materials. We invite you to attend the Foundation’s monthly webinar series presented by RLS experts and to watch past webinars online to become more knowledgeable about RLS. The Foundation also sponsors four monthly online Virtual Support Group Meetings, so you can connect with others in the RLS community for support, tips and helpful information.

RLS patients are familiar with self-advocacy, often having to play the dual role of patient and educator. Even within the medical community, a lack of understanding of RLS results in delays in proper diagnosis and treatment. Advocacy is a primary activity of the RLS Foundation, focusing on allocating funds to RLS research, increasing physician and public education, and protecting access to effective treatments.

An updated clinical guideline issued by the Centers for Disease Control and Prevention (CDC) in November failed to identify a medical exception for RLS regarding access to opioid therapy, despite exceptions being made for other medical conditions. It is important to recognize the role that low total daily doses of opioids have in providing relief for those with RLS when other treatments are not effective in controlling symptoms.

The RLS Foundation encourages everyone in the RLS community to use their advocacy voices to reach the legislative sector by participating in some of the activities suggested below!

1. Connect with Your Community

We have a network of support groups and contacts across North America that allow you to connect to the entire RLS community. Host a virtual or in-person meeting to write letters and share your RLS story with your congressional representatives. There is power in numbers. Emphasize that, without the explicit mention of RLS in CDC guidelines, state and federal agencies have the potential to deny effective treatment to the RLS community. You can visit www.congress.gov/members/find-your-member to search for your state representative’s contact information.

2. Spread Awareness

Speak to your friends, family, neighbors and healthcare providers about your experience. Educating those around you introduces them to an unfamiliar topic while encouraging them to participate in bringing about change. Social media is a great resource for sharing your message and connecting with people or groups who understand your RLS.

3. Participate in Hill Day

The Foundation hopes to host a 2023 Hill Day – a day dedicated to educating congressional representatives about the impact RLS has on physical and mental health, as well as the barriers to effective treatment. The last in-person RLS Hill Day was in 2019, when 25 members of the Foundation traveled to Washington, DC, for two days of meetings with their legislators.

You can participate in Hill Day by writing letters, submitting videos or joining the RLS Foundation team in Washington to tell your RLS story. Look for our call to action for participants in future emails, blog posts and eFriends newsletter! Learn more about making your voice heard and view the many advocacy resources on our website .

What is DEA Proposing

The DEA has proposed a change to the telemedicine prescribing rules established during the COVID-19 pandemic. This proposed change will create new barriers to treatment for those in the RLS community who have been treated via telemedicine over the past 3 years. If this change goes into effect, patients will no longer be able to receive a prescription for alpha-2-delta ligands (gabapentin, gabapentin enacarbil, pregabalin), benzodiazepines or opioids after an initial 30-day telemedicine prescription without an in-person appointment or qualified telemedicine referral (referral following an in-person doctor visit).

The RLS Foundation has certified 10 Quality Care Centers in the US where expert care is available. Telemedicine has enabled patients who live in areas where access to healthcare is limited or nonexistent to access care with a certified RLS provider.

How You Can Comment

Go to https://www.regulations.gov/commenton/DEA-2023-0029-0001 and click on the Comment box. Be succinct and tell how this prescription restriction will affect you and your quality of life. Include Docket No. DEA-407, limit your comment to 5000 characters and deadline is 11:59PM ET on March 31.

Following is the response from the RLS Foundation on behalf of the RLS community. It is imperative that each individual in the RLS community raise their voice and submit their own comment.

Requested Change in Proposed Rules

The RLS Foundation requests that the DEA change its proposed rules to exempt alpha-2-delta ligands (gabapentin, gabapentin enacarbil, pregabalin) and low-total-daily doses of opioids and comparably relax proposed rules with respect to all Schedule II-V drugs (including opioids) to permit RLS patients access to these critical treatments. Alternatively, we request a blanket exemption from the rules for patients diagnosed with RLS (ICD-10 code: G25.81). Either change can be accomplished under Exception 7 (21 C.F.R. §1300.04(i)(1)-(7)).

About Restless Legs Syndrome

RLS is a serious neurological disease affecting an estimated 12 million Americans. Patients may experience an overwhelming, agitating, and uncontrollable urge to move their legs. With symptoms peaking at night, sleep can be disrupted, exacerbating other chronic conditions and increasing the risk of depression and suicide. RLS is not chronic pain; it has a distinctly different underlying neuropathology, best managed by neurologists and/or sleep specialists.

RLS Treatment

There is a shortage of providers with the expertise to diagnose or treat RLS patients. Primary care providers are frequently unaware of the disease or current best practices, leading to long delays in diagnosis and inappropriate treatments. There are only 10 centers in the U.S. certified to provide comprehensive care; only 15% of the population is close to one of them. Thus, 85% of Americans often look to telemedicine for expert management. Diagnosis and management of RLS is based solely upon symptoms that can be evaluated as effectively through telemedicine as in person.

Existing Restrictions Already Impose Challenges to RLS Patients

Clinical experience of experts treating severe RLS with opioids has not shown drug misuse, dependence, or addiction. Results from a 2023 National RLS Opioid Registry documents that most RLS patients prescribed opioids take them in low-total-daily-doses, and generally do not exhibit dose escalation, tolerance, dependence, or opioid use disorder. Despite these facts, RLS specialists may have difficulty prescribing opioids because of institutional restrictions. Some physicians now refuse to renew long-standing opioid prescriptions. Some pharmacies reject legitimate prescriptions. Some insurers deny coverage of alpha-2-delta ligands and opioids for RLS.

Proposed Changes Create New Barriers to Treatment

Updated consensus treatment guidelines recommend iron therapy and alpha-2-delta ligands (Schedule V) as first-line treatments for RLS. Low-total-daily dose opioids -- buprenorphine (Schedule III) and methadone (Schedule II) -- are now recommended for the treatment of moderate-to-severe RLS refractory to other approaches.

Under the DEA’s proposed changes, telemedicine providers would be restricted to an initial 30-day prescription of Schedule II-V medications for RLS and is unable to provide future controlled medications without conducting an in-person exam or a qualified telemedicine referral. All telemedicine prescriptions would be required to have the notation “telemedicine prescription.” Taken together, these rules create significant barriers to accessing legitimate pharmacological treatment.

Effect of the Proposed Rules

The proposed rule changes will have a significant negative impact on RLS patients and their medical practitioners. With the difficulty that patients suffering from RLS already experience in finding a knowledgeable local doctor, any new barriers to telemedicine management would be devastating since many RLS patients are treated with controlled substances. The problem would be dramatic for those on low-total-daily-dose opioids who would face the sudden loss of the most potent treatment for refractory RLS.

Summary

RLS can be a devastating neurologic disorder, treated safely and effectively by telemedicine providers, who are often prescribing controlled substances. The DEA should consider relaxing the devastating effect that this will have on the RLS community and ease restrictions on the telemedicine prescribing of controlled substances with exemptions for medications and RLS patients as recommended above.

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

Background

For the fifth 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 March 22. Take action TODAY, it is imperative! Here’s how:

1. To find the appropriate staff member who handles healthcare (the Health LA) in your Representative’s DC office, first contact our sleep community advocacy staff, Josh Fein at Fein@hmcw.org to provide your home address so Josh can identify your House Representative’s Health LA.
2. Email your Representative’s Health LA using the draft message below and attach the FY24 Sleep Sign On Letter PDF (click here to download letter). Please note, you do not need to click the “Quill” link and form mentioned in the sample email; that link only works for House offices.

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

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

To: [Your House Representative’s Health LA’s Email]
Cc: clara@rls.org
Subject: Sign On Letter – Sleep Community

Dear [Staff Member’s Name],

My name is [your name] and I am a constituent from [hometown]. I am also an advocate for the sleep community. I hope your office will join the attached Sign on Letter, which supports the sleep community’s appropriations recommendations for FY 2024. To sign on, please complete this form via Quill by the deadline of March 22nd. Please contact Kaitlyn Kelly at Kaitlyn.Kelly@mail.house.gov with any questions.

Thank you for your time and for considering this request.

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

ATTACHMENT: FY24 Sleep Disorders Sign on Letter (http://www.rls.org/file/advocacy/FY24-Sleep-Sign-on-Letter.pdf)

-----*   *-----

Questions? Email Josh Fein at Fein@hmcw.org with any questions. Thank you for raising your voice for sleep research and awareness!

Restless Legs Syndrome: More Than a Sleep Disorder

For decades, restless legs syndrome (RLS) has been referred to as a “sleep disorder.” Does RLS cause sleep issues? Absolutely yes. But to think that RLS is simply a sleep disorder is like thinking that a Boeing 747 wide-body jet airliner is simply an airplane. I feel obliged to spell it out: RLS is not just a sleep disorder for individuals with advanced or severe symptoms.

For many people like me who suffer from RLS, symptoms are not just a sleep disturbance that affects us at night. Without effective treatment, we would battle symptoms 24 hours a day, seven days a week. In the beginning, my symptoms started at night in my legs, when I was tired and trying to sleep. Then, over time, the intensity of the symptoms increased, and now they affect not only my legs but my arms, back, hips and neck.

An accurate description of how advanced symptoms really feel can only be described by someone who has RLS. I feel like I have to move my legs. And I do … I have to move my legs. When I do move my legs, I feel immediate, total relief for about three seconds. Then I have to move again. The feeling caused by severe RLS symptoms is misery and pain, and no amount of willpower can overcome the driving need to move. For me, the more tired I am, the worse the symptoms become. Sometimes I have to move my legs, arms and hips, and even bend my back to find a mere few seconds of relief.

Severe RLS symptoms have been described to me as a feeling of nerves moving under the skin … a “creepy- crawly” sensation that is overwhelming, all-consuming and miserable. You can’t keep from moving. You can’t be still. You can’t sleep. You can’t relax. You have to move. You feel it all over your body and it hurts.

For many individuals suffering from RLS (including me), symptoms are so severe that without effective treatment we would not be able to function. Without treatment, we would not be able to hold jobs, raise families and contribute to society in a positive way. We would not be able to sleep, use a computer, read a book or watch TV.

For others like me who have debilitating RLS symptoms, to characterize this suffering as a “sleep disorder” doesn’t begin to tell the whole story.

Richard R. Mahaffey received a Bachelor of Science in chemistry from the University of Virginia at Wise in 1973. He worked from 1973 to 2019 as a chemist, IT professional, author, editor and project manager. He was diagnosed with RLS in the 1980s and was a member of the Northeast Tennessee RLS Support Group from 2015 to 2018.

Don’t Lose Hope

My search for understanding and help spanned 30 years, multiple primary care practitioners, many specialists, a wide array of prescription and over-the-counter drugs, and non- medical therapies – all while my RLS was taking an increasing toll on me and my ability to function. It got to the point where I would wake up each morning after only one or two hours of fitful sleep, wishing I just wouldn’t wake up at all. It was difficult to process even basic thoughts, making each day miserable. And I knew that the night would be a repeat of every night for the past seven-plus weeks, where time dragged on with repeated unsuccessful attempts to go to bed and fall asleep, until I was so mentally exhausted that I’d finally find sleep around 4 am, and only for an hour or two. I was at my wit’s end and turned my limited attention to finding a dignified way out – to end my suffering by ending my life.

The point of this article is self-advocacy – a concept that had eluded me all the years my RLS was progressing. I’d hoped to find a doctor to quickly diagnose my tightening toes and calf muscles at night and fix it. When I had a shattered shoulder, a doctor fixed it. When I had a heart attack, a doctor fixed it. When I had cancer, a doctor fixed it. I could always lean on a doctor to help me solve a problem and get on with life. Not so with RLS.

It’s a paradox. So many people have RLS or know someone who does, and many physicians have at least heard about RLS. The problem is that the body of knowledge at all levels is outdated and often leads to ineffective or even harmful advice.

After many primary care appointments and referrals to a variety of specialists, I was referred to a neurologist. In response to my query about his familiarity with RLS, he replied “Sure. We all have a chapter on RLS at university,” and prescribed a drug that is now known to worsen RLS symptoms, as it did with me. My mood was declining rapidly, and a variety of antidepressants were prescribed that are also now known to trigger RLS symptoms, as they did with me. I was in tough shape.

My primary care physician learned of a sleep doctor who had success with a drug called pramipexole. I was referred with a sense of urgency. She confirmed that I had RLS and that it wasn’t just a muscle cramp thing. Validation, at least! The pramipexole worked the first night. Relief! Hope! But after about eight months, I was needing more of it, earlier in the day. I learned of an obscure concept called augmentation, and I had to quit the drug. The next two weeks were miserable, weaning myself from it. My wife had read that opioids were effective and asked the sleep doctor about them, to which she replied, “That’s a red-flag drug.” Another dead end, quickly destroying what little hope I’d gained.

At this point, it became apparent that I had to advocate for myself. Most information led to the same dead-end advice of the past, since it was all based on the same outdated research findings the physicians “studied in the chapter at university.” I found the RLS Foundation and their discussion boards. Finally, a great resource with a bounty of information. Through it, I found a support group that I attended. It was nice not to be alone in my suffering. I learned of a doctor who had more advanced knowledge of RLS. I went to him, and after a thorough assessment, he asked me to try opioids. “I thought it was a red-flag drug,” I replied. “Yes, but your condition is more important than the scrutiny it brings.” I tried an opioid and it worked. Thank God!

I continued my research and learned of advanced studies by Christopher Earley and Richard Allen at Johns Hopkins, John Winkelman at Harvard, and others. The relationship with my RLS doctor turned into more of a partnership where we benefitted each other with our research. I learned of emerging thoughts about iron and the blood-brain barrier, and a particular type of iron infusion that might help. It did help. I learned of a different kind of opioid, called buprenorphine, that didn’t contribute to depression. It worked very well! I consider it a game changer for me.

I am now returning to the high-quality, active life that I had lost. I am forever indebted to the scarce few physicians who are blazing the trail on RLS, and the RLS Foundation for disseminating that information.

My message to you? Find the energy and courage to advocate for yourself. It can work.

Barry Otterholt is a (mostly) retired project management specialist, known for recovering troubled IT projects for a number of different state governmental agencies. He lives in the beautiful Pacific Northwest with his family. He and his wife are avid scuba divers who prefer to go where palm trees grow. He also loves exploring the backroads of the U.S. on his motorcycle.