Can Sibelium (Flunarizine) be given for migraine prophylaxis?

Flunarizine (Sibelium) for Migraine Prophylaxis

Yes, Flunarizine (Sibelium) can be given for migraine prophylaxis as it has proven efficacy at a dose of 10 mg/day and is commonly used in countries where it is available. 1

Efficacy and Evidence

• Flunarizine 10 mg/day has demonstrated effectiveness in preventing migraine attacks in multiple placebo-controlled studies 1
• Comparative trials show flunarizine is at least as effective as propranolol (160 mg daily), a first-line migraine preventive medication 2, 3
• In clinical trials, flunarizine reduced migraine attack frequency up to 4-fold, similar to the reduction seen with propranolol 2
• The 10 mg dose appears more effective than 5 mg, with responder rates (≥50% reduction in attacks) of 53% vs 46% respectively 3

Dosing and Administration

• The standard recommended dose is 10 mg once daily, typically taken at bedtime 1, 4
• Some regimens include a "drug-free weekend" approach which maintains efficacy while potentially reducing side effects 3
• Treatment duration of 3-6 months is typically required to evaluate full efficacy, as clinical benefits may take 2-3 months to fully manifest 1, 4

Side Effects and Monitoring

• Common side effects include:
  • Sedation/drowsiness 1
  • Weight gain (reported in approximately 30% of patients) 2, 5
  • Abdominal pain 1
• More serious but less common adverse events include:
  • Depression 1
  • Extrapyramidal symptoms, particularly in elderly patients 1
• Regular monitoring for these side effects is essential, especially in elderly patients who are more susceptible to extrapyramidal effects 1

Clinical Considerations

• Flunarizine should be considered when:
  • First-line preventives (beta-blockers, topiramate, anticonvulsants) have failed 1
  • Patient has contraindications to other preventive medications 2
  • Migraine attacks occur with sufficient frequency to warrant prevention (generally ≥2 attacks per month) 1
• Caution should be exercised in:
  • Patients with a history of depression 1
  • Elderly patients due to increased risk of extrapyramidal symptoms 1
  • Patients concerned about weight gain 1, 2

Comparative Place in Therapy

• Current US guidelines (2023 VA/DoD) do not specifically mention flunarizine among first-line preventive options, which include CGRP antagonists, ARBs, and topiramate 1
• In countries where available, flunarizine is considered comparable to beta-blockers (propranolol, metoprolol) in efficacy for migraine prevention 6, 3
• The benefit-risk ratio of flunarizine is considered favorable when compared to other preventive options 6

Important Clinical Pitfalls

• Patients should be informed about potential weight gain, which occurs in a significant percentage of users 2, 5
• Treatment should be continued for at least 3 months to properly assess efficacy 1
• Flunarizine should be avoided in patients with significant depression or those at high risk for developing depression 1
• When discontinuing, consider gradual tapering rather than abrupt cessation, particularly after long-term use
• Monitoring for extrapyramidal symptoms is particularly important in elderly patients 1