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Requip® (ropinirole HCL) approved for RLS

Posted by jerrympls on May 10, 2005, at 19:00:04

I realize that this isn't directly related to mood disorders, but it does effect many of us who have insomnia (and other mood disorders).

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Washington DC, May 9, 2005 -- The U.S. Food and Drug Administration has approved Requip® (ropinirole HCL) for the treatment of primary Restless Legs Syndrome (RLS) in adults. Requip® is the first FDA-approved treatment for those patients with moderate-to-severe primary RLS, a condition that affects approximately one in ten adults in the U.S. and can profoundly disrupt sleep as well as daily activities.

Symptoms of RLS include an uncomfortable feeling in the legs (e.g. tingling, creepy, itching, pulling or aching) accompanied by an urge to move them during periods of inactivity, including both sleep and wakefulness. Symptoms may also include involuntary jerking of the limbs that intensify in the evening or at night and are relieved by movement. Because people with RLS tend to have difficulty falling or staying asleep, chronic sleepiness is also a frequent symptom of the disease.

The cause of RLS is unknown but researchers believe that it may be related to dopamine, a chemical that carries the signals between nerve cells that control body movement. When the dopamine system does not function properly, it may upset the normal communication of these signals. Requip® works by stimulating dopamine receptors in the brain, thus promoting better, easier movement.

RLS has a primary form not related to other disorders and a secondary form related to an underlying condition such as iron deficiency, pregnancy, or kidney failure. It may also be caused or made worse by certain medications. This is considered secondary RLS. When no other cause is found for RLS symptoms, it is considered a primary disorder. People experiencing RLS symptoms should discuss them with a physician to help obtain an accurate diagnosis.

The approval of Requip® for moderate-to-severe primary RLS comes after double-blind, randomized, placebo-controlled clinical trials showed that the drug significantly reduced symptoms and improved sleep quality in adults with primary RLS. Patients with secondary RLS were excluded from the clinical trials.

Requip® may cause patients to fall asleep or feel very sleepy while doing normal activities such as driving; or to feel faint or dizzy, nauseated or sweaty, when they stand up from sitting or lying down. If patients experience these problems, they should talk to their doctor.

More information about RLS and other sleep-related problems is available at http://www.sleepfoundation.org .

(http://sleepfoundation.org/press/index.php?secid=&id=147)


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poster:jerrympls thread:496170
URL: http://www.dr-bob.org/babble/20050510/msgs/496170.html