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Sleep Help
Restless Legs Syndrome Gets Its First FDA Approved
Treatment
Requip was first approved to treat Parkinsons
disease in 1997
April 9, 2005 - The Food and Drug Administration
has approved Requip (ropinirole) to treat moderate to severe Restless
Legs Syndrome (RLS), an ailment that often strikes senior citizens. The
drug was first approved for Parkinsons disease in 1997.
Restless Legs Syndrome is a condition that affects
about ten percent of the population but about 30 percent of those over
65. The disorder is characterized by an urge to move the legs, usually
accompanied by or caused by uncomfortable leg sensations. For most
people with the condition, symptoms begin or worsen during periods of
rest or inactivity and are partially or totally relieved by movement.
Symptoms typically worsen or occur only in the evening or at night, and
can disturb sleep.
Requip was found to be effective for RLS in three
randomized, double-blind placebo controlled studies in adults diagnosed
with moderate to severe RLS. The studies measured effectiveness of the
drug using the International Restless Leg Syndrome Scale, a patient
rated scale that measures different aspects of RLS including severity of
muscle movement and discomfort, sleep disturbance, mood and overall
effect on quality of life. The Clinical Global Impression-Global
Improvement scale was also used. This is an investigator rated scoring
of improvement following treatment. All three studies demonstrated a
statistically significant difference between the treatment group
receiving Requip and the group receiving placebo.
Common side effects of Requip reported in clinical
trials include nausea, headache, and vomiting. The label for the drug
will also include a caution that Requip has been associated with
sedating effects, including somnolence (sleepiness), and the possibility
of falling asleep while engaged in activities of daily living, including
operation of a motor vehicle. Syncope (fainting) or symptomatic
hypotension (low blood pressure) may occur, particularly during initial
treatment or dosing.
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