From the FDA Drug Label
Restless Legs Syndrome: Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. The most commonly observed adverse events (>5%) in the 12-week double-blind, placebo-controlled trials in the treatment of Restless Legs Syndrome with ropinirole hydrochloride (n = 496) and at least twice the rate for placebo-treated patients (n = 500) were, in order of decreasing incidence: nausea, somnolence, vomiting, dizziness, and fatigue
The symptoms of Restless Leg Syndrome (RLS) include:
- An urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations
- Symptoms begin or worsen during periods of rest or inactivity such as lying or sitting
- Symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues
- Symptoms are worse or occur only in the evening or night
The treatment options for RLS include:
- Ropinirole hydrochloride tablets, which are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS)
- Common adverse events associated with ropinirole hydrochloride tablets in the treatment of RLS include:
- Nausea
- Somnolence
- Vomiting
- Dizziness
- Fatigue 1
From the Research
Restless Leg Syndrome (RLS) should be treated with alpha2-delta calcium channel ligands, such as gabapentin or pregabalin, as first-line pharmacological treatment, due to their efficacy and lower risk of augmentation compared to dopamine agonists, as suggested by the most recent study 2. The symptoms of RLS include uncomfortable sensations in the legs with an irresistible urge to move them, typically occurring during periods of rest, especially in the evening or at night. Symptoms can be described as crawling, tingling, or aching feelings in the legs that are temporarily relieved by movement. For mild RLS, lifestyle modifications are the first approach, including:
- Regular exercise
- Avoiding caffeine and alcohol
- Maintaining good sleep hygiene
- Applying warm or cold compresses For moderate to severe cases, medication is necessary. Some key points to consider in the treatment of RLS include:
- Iron supplementation (ferrous sulfate 325 mg with vitamin C for absorption) is recommended for patients with ferritin levels below 75 ng/mL, as iron deficiency can worsen RLS symptoms 2.
- Treatment should be monitored regularly for augmentation, a phenomenon where symptoms worsen or begin earlier in the day due to long-term dopaminergic medication use 2, 3, 4.
- Alternative pharmacological agents, such as clonidine, adenosinergic agents, glutamate AMPA receptor blocking agents, and various anticonvulsants, may be considered for patients who do not respond to first-line treatments or experience intolerable side effects 5. However, the most recent and highest quality study 2 suggests that alpha2-delta calcium channel ligands, such as gabapentin or pregabalin, should be the first-line pharmacological treatment for RLS, due to their efficacy and lower risk of augmentation compared to dopamine agonists.