Diagnosis of restless legs syndrome (RLS) can be made if all of the following four criteria are met:
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| > a need to move the legs, usually accompanied or caused by uncomfortable, unpleasant sensations in the legs, |
| > symptoms are exclusively present or worsen during periods of inactivity/rest, |
| > symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity |
continues. | > symptoms are generally worse or exclusively occur in the evening or during the night | |
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Guidelines on the management of Restless Leg Syndrome in primary care can be accessed here
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Once a diagnosis has been made, the patients severity of symptoms should be scored using the International Restless Leg
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Syndrome (IRLS) rating scale. See appendix II.
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Other secondary cases should be referred to a specialist for diagnosis (e.g. renal failure). Dopamine agonists are not licensed for
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the management of secondary RLS, only idiopathic RLS. Try to avoid drugs that can exacerbate symptoms (CNS stimulants,
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diuretics, tricyclic antidepressants, calcium antagonists, phenytoin).
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Patients with paroxsysmal RLS should be offered advice on sleep hygiene and other non-pharmacological measures which will
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reduce symptoms in some patients. Should these measures fail, pramipexole may be offered on a ‘when required’ basis in line
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with the recommendations below.
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Patients with moderate to severe RLS (as rated on the IRLS scale, 15 to 40 points) should also be offered sleep hygiene advice and
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non-pharmacological measures. Patients may consequently be offered treatment with pramipexole, which may be initiated by any
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prescriber for the treatment of restless leg syndrome (RLS) in line with the product licence and the following recommendations;
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| > to be initiated in patients with primary (idiopathic) RLS only |
| > serum ferritin should be checked to exclude iron deficiency as a cause. If ferritin <20mcg/L then oral iron |
| supplementation should be offered initially |
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Pramipexole – 1st Line Choice
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| > treatment should be initiated at pramipexole 125micrograms/day. Many patients respond to this dose within one week. |
| Dose increases to pramipexole 125micrograms/day and pramipexole 500micrograms/day should be undertaken in one |
| week intervals only where necessary. Maximum dose of pramipexole 750micrograms/day should rarely be required. |
| The dose should be taken 2-3 hours before bedtime. [Doses stated relate to pramipexole dihydrochloride] |
> Patients should be counselled that treatment with a dopamine agonist can in some patients exacerbate symptoms, or cause them to appear earlier in the day (augmentation). Some patients see a rebound in symptoms on cessation of
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| treatment. Relapse rates with long term treatment are also unknown at this stage. Dopamine agonists can also cause |
| sudden hypersomnia - patients should also be warned of this overwhelming sensation of sleepiness occurring with little |
| or no warning, and the need to exercise caution when driving or operating machinery. They are also rarely associated |
| with pathological gambling. |
| > Treatment should be reviewed at 3 months and stopped if little or no benefit seen. Patients should be referred where |
| there is neurological comorbidity (if this requires assessment or seriously impedes diagnosis), failure of response to two |
| dopamine agonists, or augmentation occurs. |
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GREEN Generic Pramipexole dihydrochloride tabelts 125 micrograms, 250 micrograms
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Ropinirole – 2nd Line Choice
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Ropinirole may only be initiated for the treatment of RLS where the use of pramipexole is inappropriate, not tolerated or
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ineffective. Efficacy data for the licence for ropinirole comes from those patients with an IRLS score of 24 or above (rather than 15
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or above with pramipexole); dose titration is slower than with pramipexole and costs more at the average dose. Starter packs are
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available for initial dose titration up to 0.5mg/day.
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GREEN Ropinirole
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tablets 0.25mg, 0.5mg, 2mg & ‘starter pack’
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