Restless Legs Syndrome (RLS) is a neurological disorder that causes an irresistible urge to move the legs accompanied by leg discomfort. Without adequate treatment, RLS symptoms can interfere with sleep and reduce quality of life.

Common Treatments for RLS

The FDA has approved four drugs for treating RLS:

  • Ropinirole (Requip®)
  • Pramipexole (Mirapex®)
  • Rotigotine (Neupro®)
  • Gabapentin enacarbil (Horizant®)

These non-opioid medications work for some people, but there are some limitations to current treatments for RLS. For example, long-term use of certain medications can make RLS worse for some people.

Opioid Medications for RLS

Opioid medications have been used to successfully treat the symptoms in many patients with severe RLS or in patients who have found that conventional treatments have lost effectiveness.

However, the current climate of escalating opioid addiction and deaths from opioid overdose have resulted in increasingly strict regulation of these medications. Further regulations may make obtaining opioids for RLS more difficult, so both patients and physicians need more scientific evidence to assess the risks and benefits of treating RLS with opioids.

Learn more about the use of opioid medications for RLS: Opioids in the Treatment of RLS, Restless Legs Syndrome Foundation.

The RLS Opioid Registry

We are building an RLS Opioid Registry based at Massachusetts General Hospital with patients all around the country to assess the long-term safety and effectiveness of opioid medications for RLS.

A registry is an observational study method that collects data on a certain group of people. The RLS Opioid Registry will collect data from people who have been diagnosed with RLS and are taking (or planning to take) a prescribed opioid as treatment. This data will then be used to evaluate specific treatments and outcomes for those living with RLS.

Learn more about the RLS Registry


Visit Restless Legs Syndrome Foundation website to learn more about RLS symptoms, treatment and ongoing research.


Note: We will not be providing any consultation, advice about clinical care or medication through this study.


About the RLS Registry

What Will My Participation Involve?

Participating in the RLS Registry is simple. You will be asked to do the following:

  • An initial phone interview about your RLS symptoms, current and past treatments and other medical conditions (approximately 45 minutes)
  • Filling out an online questionnaire to update us on your RLS symptoms, sleep quality, habits and mood two times per year for up to 5 years(approximately 30 minutes)

All data will be stored anonymously in a secure electronic database at Mass General. We will summarize group data on long-term dosages, effectiveness and side effects of using opioids for RLS.

Who Is Eligible?

You may be eligible to participate in this registry if you:

  • Are 18-90 years old
  • Have a current RLS diagnosis
  • Are currently taking or plan to take an opioid medication to treat RLS, including oxycodone (i.e. Percocet®, OxyContin®), methadone, buprenorphine (i.e. Suboxone®), hydrocodone (i.e. Vicodin®)

Benefits of Participation

In addition to helping increase our understanding of opioid treatments for RLS, we will send you personal and group data summaries each year. These summaries will visually show opioid dosing data, treatment efficacy and the most common side effects.

Enroll now

How to Enroll

Please contact us to enroll in the National Restless Legs Syndrome Opioid Registry:



For Clinicians

If you wish to inform your patients about the National RLS Opioid Registry, please contact us for informational materials. We can provide study brochures with study enrollment information that can be given to patients.

Please contact us to receive a shipment:

To learn more about Dr. Winkelman’s research grant, please visit the RLS Foundation Blog.
To learn more about RLS, visit the Restless Legs Syndrome Foundation website.

Contact Us

John W. Winkelman, MD, PhD
Principal Investigator
Massachusetts General Hospital
Sleep Disorders Clinical Research Program
1 Bowdoin Square, 9th Floor
Boston, MA  02114

Phone: 617-643-2082  
Fax: 617-643-6050