12 Million Can't Sleep, Can't Sit With Restless Legs Syndrome

When Richard Jefferson was 7 years old, his legs twitched so uncomfortably his parents would put them in ice packs to ease the creepy-crawly pain.

As he got older, the symptoms got worse: When in bed his legs flailed and woke him from sleep, and he couldn't sit through a movie or dinner at a restaurant.

"I used to beat them because I would rather have pain than restless legs," said Jefferson, now 62, of Rochester, N.Y. Once the retired assemblyman became so distressed he checked into the emergency room and received morphine. "The minute you sit down, it starts all over again. I've had to plan my life around it."

Jefferson -- like an estimated 12 million Americans -- suffers from restless legs syndrome, a neurological disorder characterized by an uncontrollable urge to move when at rest. Many more people go undiagnosed or misdiagnosed, according to the Restless Legs Foundation.

Sensations are often described as burning, creeping, tugging, or like insects crawling inside the legs. They can range from irritating to painful. Patients complain that they cannot sleep, and if the condition is left untreated, it can cause exhaustion and lead to social isolation.

For decades, Jefferson has searched to find the right medicine, and when doctors prescribed Requip (ropinirole) -- the drug most commonly prescribed for RLS -- he found relief. But only for six months. Then the treatment backfired.

In a recent article in the Journal of General Internal Medicine, neurologists at the University of Rochester Medical Center warned that drugs like Requip and a similar drug Mirapex (pramipexole) can actually make the symptoms worse.

These drugs -- so-called dopamine agonists -- have an "augmentation" effect -- that is, they can heighten the symptoms they are ostensibly treating. They act on dopamine receptors in the brain that help coordinate smooth movement.

These newer drugs, which are safer and have fewer side effects, have replaced dopamine drugs like Levodopa and Sinemet for treatment of RLS. The older drugs can cause intense movement, low blood pressure and nausea, and cause problems when used long-term.

Other drugs used for RLS, like narcotic painkillers and benzodiazepines, produce the opposite effect of the dopamine agonists. With long-term use, patients require higher doses, which produce side effects, including addiction.

Requip has historically been used to treat Parkinson's disease and Tourette's syndrome. But in the past year, the drug has been heavily marketed for treatment of RLS in direct-to-consumer advertising. One prominent ad for Requip aired during the Super Bowl last year.

"It's impossible to tell the whole story in a TV spot just a few seconds long," said Dr. Irene Richard, a movement disorder neurologist at Rochester Medical Center. "When patients come in asking about the treatment, doctors need to know that this is usually not a simple, single-pill solution, despite what they've seen on TV."

Rochester neurologists recommend doctors rotate patients through a variety of drugs to avoid augmentation.

"We think of the dopamine medicines as benign and controlled substances like Valium as addictive," Richard said. "But you have to be careful not to make the situation worse, and what is heralded as benign is not."

Requip is manufactured by GlaxoSmithKline, which saw a 34 percent increase in sales to about $78 million following its U.S. marketing launch for treatment of RLS, according to the company's 2005 annual review.

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