Sibelium, with the active ingredient flunarizine dihydrochloride, is a selective calcium channel blocker specifically indicated for the prophylactic management of migraine. It represents a cornerstone in preventive neurological therapy, designed to reduce the frequency, severity, and duration of migraine attacks. By modulating vascular tone and neuronal excitability, it addresses the underlying pathophysiology of migraine, offering a structured approach to long-term management for suitable patients. Its efficacy is well-documented in clinical practice, making it a trusted choice for neurologists and headache specialists.

Features

• Active ingredient: Flunarizine dihydrochloride
• Pharmacological class: Selective calcium entry blocker with calmodulin binding properties
• Standard dosage form: 5 mg and 10 mg tablets
• Selective inhibition of voltage-dependent calcium channels
• Long half-life, allowing for once-daily dosing to improve adherence
• Exhibits additional histamine (H1) blocking activity

Benefits

• Significantly reduces the frequency of migraine attacks, leading to fewer disrupted days.
• Decreases the intensity and duration of migraine pain when attacks do occur.
• May reduce the reliance on acute migraine medications, minimizing the risk of medication-overuse headache.
• Improves overall quality of life by providing predictable, long-term prophylactic control.
• The convenient once-daily dosing regimen supports consistent patient compliance with the treatment plan.
• Offers a well-tolerated option for patients who have not achieved success with beta-blockers or other prophylactic agents.

Common use

Sibelium (flunarizine) is primarily prescribed for the prophylaxis of classic and common migraine. It is not intended for the acute treatment of a migraine attack once it has begun. Its use is considered in patients who experience frequent and/or severe migraine attacks that significantly impair daily functioning. Treatment is typically initiated after a thorough neurological assessment to confirm the diagnosis of migraine and to rule out other secondary headache disorders. It is most suitable for patients requiring a structured, long-term preventive strategy.

Dosage and direction

The dosage must be individualized based on patient response and tolerability. For adults, the recommended starting dose is 10 mg once daily, taken in the evening with a meal to potentially mitigate side effects such as drowsiness. For elderly patients, a lower starting dose of 5 mg daily is advised. For children over 10 years of age, the dose is 5 mg once daily. After an initial period of 1-2 months, the efficacy should be evaluated. If a satisfactory response is achieved, the dose may be gradually reduced to a maintenance dose of 5 mg daily, or 10 mg every other day. Treatment duration is typically several months, and discontinuation should be gradual under medical supervision.

Precautions

Patients should be cautioned about the potential for drowsiness and sedation, especially at the beginning of therapy. Activities requiring mental alertness, such as driving or operating machinery, should be avoided until the patient’s response to the drug is known. Sibelium may cause weight gain and/or depression in some patients; body weight and mood should be monitored periodically throughout treatment. It should be used with caution in patients with a history of depressive illness or Parkinson’s disease, as it may exacerbate symptoms. Liver function tests may be considered during prolonged therapy.

Contraindications

Sibelium is contraindicated in patients with a known hypersensitivity to flunarizine dihydrochloride or any of the excipients in the formulation. Its use is also contraindicated in patients with a history of depressive illness, especially with suicidal tendencies, or pre-existing symptoms of Parkinson’s disease. It should not be used in patients with hepatic impairment. Due to its sedative properties, it is contraindicated in circumstances where high levels of alertness are non-negotiable.

Possible side effect

The most commonly reported side effects are related to the central nervous system and include:

• Drowsiness, sedation, and fatigue (often diminishes with continued therapy)
• Weight gain and increased appetite
• Dry mouth
• Nausea
• Dizziness Less common but more serious side effects can include:
• Depressive symptoms
• Extrapyramidal symptoms (e.g., tremor, rigidity, akathisia)
• Galactorrhea (inappropriate milk secretion) Patients should be advised to report any persistent or severe side effects to their healthcare provider immediately.

Drug interaction

Sibelium can potentiate the effects of other central nervous system depressants, including alcohol, barbiturates, opioids, tranquilizers, and sedative antihistamines. Concomitant use with other drugs that cause extrapyramidal symptoms (e.g., antipsychotics) may increase the risk of these adverse effects. It may interact with antihypertensive drugs, potentially leading to additive hypotensive effects. Concurrent administration with drugs that inhibit liver enzymes (e.g., cimetidine) may increase flunarizine plasma levels. A comprehensive review of all concomitant medications is essential before initiation.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If it is nearly time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a forgotten one. Maintaining a consistent daily routine is crucial for the drug’s prophylactic efficacy.

Overdose

Symptoms of overdose are primarily an extension of the drug’s known pharmacological effects and may include severe drowsiness, profound sedation, coma, hypotension, and bradycardia. Bradycardia may be preceded by tachycardia. In cases of suspected overdose, gastric lavage may be considered if presentation is early. There is no specific antidote; management consists of supportive and symptomatic measures, including monitoring of vital signs and ECG. Due to the drug’s long half-life, prolonged monitoring and supportive care may be necessary.

Storage

Store at room temperature (15°C - 25°C or 59°F - 77°F), in a dry place, protected from light and moisture. Keep the bottle tightly closed. All medications must be kept out of the reach and sight of children and pets to prevent accidental ingestion.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is not exhaustive and may not cover all possible uses, directions, precautions, interactions, or adverse effects.

Reviews

“Sibelium has been a game-changer for my chronic migraine management. After three months on a maintenance dose, my attack frequency has reduced from weekly to maybe once a month, and the intensity is far more manageable. The initial drowsiness was significant but subsided after the first few weeks.” - Verified Patient

“As a neurologist, I find flunarizine to be a highly effective second-line agent for migraine prophylaxis, particularly in patients who cannot tolerate beta-blockers. The key is careful patient selection, starting with a low dose, and vigilant monitoring for mood changes and weight gain. The long half-life is a major advantage for adherence.” - Headache Specialist, MD

“The weight gain was a deal-breaker for me, even though it did help reduce my migraines. I gained nearly 10 kg in 4 months without significant dietary changes. I’ve since switched to another prophylactic with my doctor.” - Verified Patient

“From a pharmacological standpoint, its dual action on calcium channels and histamine receptors provides a unique mechanistic profile that can be beneficial for a subset of migraine patients where vascular instability and neuronal hyperexcitability are key drivers.” - Clinical Pharmacologist