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

April 24, 2023 Help! I Think I Have Augmentation and Don’t Know What to Do! Each day at the RLS Foundation we receive calls from ind...


April 24, 2023
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.

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