Restless legs syndrome drug approved; questions linger

For those who believe their twitchy legs are an illness -- there’s another pill for that.

Restless legs syndrome -- in which creeping and tugging sensations make moving your legs an irresistible urge -- can now officially be treated with a seizure drug. The FDA approved gabapentin, or Horizant, on Thursday after two 12-week clinical trials showed it relieves the symptoms of restless legs syndrome, compared to a placebo.

People with restless legs syndrome get the overwhelming urge to move their legs, especially after lying down. The condition is worst at night, and sufferers sometimes have to pace for hours to relieve the discomfort. The cause of the twitchiness is mostly unknown; some suspect genetics is at least partly to blame, but the condition also can occur with diseases such as kidney failure and diabetes and with certain medications.

But not all doctors and health experts agree the symptoms are an actual disorder or syndrome worthy of treatment (to the dismay of those with restless legs). Nor do they believe it’s as widespread as some say it is (by some estimates, 3% to 15% of the U.S. population).


A paper titled Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick, presents the skeptics’ case via PLOS Medicine.

The Neurologica blog presents an equally compelling case that the condition is a significant problem.

Whether or not the syndrome is exaggerated, the drugs are real. Gabapentin is the third drug the FDA has approved to treat restless legs syndrome. It’s a type of anticonvulsant that quiets abnormal excitement in the brain.

And if two 12-week trials don’t seem exceptionally reassuring, sufferers can perhaps check out the other two approved drugs, Mirapex and Requip, both originally designed for treating Parkinson’s disease.

Both of those drugs work by taking the place of the brain chemical dopamine, which is needed to control movement.

All three drugs focus on the brain for leg (and other limb) relief. But it’s not clear how to combat the physical stress that comes from twitching your leg muscles. Heart problems might be more likely among people who toss and turn at night with twitchy legs, in another restless legs headline this week. Researchers found that twitching legs at night is linked to having a thicker heart wall and an increased risk of heart attack.

The syndrome won’t be understood anytime soon. But perhaps it should be comforting that where a condition exists, a search for treatment will follow – if enough people have the condition, of course.