The treatment of restless legs syndrome with intravenous iron dextran

Sleep Med. 2004 May;5(3):231-5. doi: 10.1016/j.sleep.2004.03.002.


Background and purpose: To evaluate the safety and efficacy of a single 1000 mg iron infusion in treating Restless Legs Syndrome (RLS).

Patients and methods: A single 1000 mg intravenous (IV) [Am J Med Sci 31 (1999) 213] infusion of iron dextran was evaluated in an open-label study. Primary outcomes of efficacy were symptom severity assessed by global rating scale and periodic leg movements in sleep (PLMS) at 2 weeks post-infusion. Secondary outcomes included total sleep time (TST), hours/day of RLS symptoms, and changes in magnetic resonance imaging (MRI)-determined iron concentrations in the substantia nigra. Primary safety measures were reported adverse events and monthly serum ferritin levels.

Results: IV iron therapy significantly improved the mean global RLS symptom severity, TST, hours with RLS symptoms and PLMS, but on an individual basis failed to produce any response in 3 of the 10 subjects who were fully treated. Brian iron concentrations at 2 weeks post-infusion as determined by MRI were increased in the substantia nigra and prefrontal cortex. Serum ferritin levels showed a greater than predicted rapid linear decrease. Side effects were mild, except in one subject who developed an acute allergic reaction.

Conclusions: The results in this study provide valuable information for future studies, but the efficacy and safety of IV iron treatment for RLS remain to be established in double-blind studies. The serum ferritin results suggest that greater than expected iron loss occurs after IV iron loading.

MeSH terms

  • Aged
  • Brain / anatomy & histology*
  • Brain / metabolism
  • Female
  • Ferritins / blood
  • Humans
  • Injections, Intravenous
  • Iron-Dextran Complex / administration & dosage
  • Iron-Dextran Complex / pharmacokinetics
  • Iron-Dextran Complex / therapeutic use*
  • Male
  • Middle Aged
  • Prefrontal Cortex / anatomy & histology
  • Prefrontal Cortex / metabolism
  • Restless Legs Syndrome / diagnosis
  • Restless Legs Syndrome / drug therapy*
  • Severity of Illness Index
  • Substantia Nigra / anatomy & histology
  • Substantia Nigra / metabolism


  • Iron-Dextran Complex
  • Ferritins