Zolmitriptan

Zolmitriptan is a prescription medication used for treating the symptoms of migraine.

• Zolmitriptan is available under the following different brand names: Zomig, Zomig Rapimelt, Zomig-ZMT

Adult and pediatric dosage

Tablet

• 2.5mg (scored)
• 5mg

Oral disintegrating tablet

• 2.5mg
• 5mg

Intranasal spray

• 2.5mg/single-use device
• 5mg/single-use device

Migraine

Adult dosage

• 2.5 mg orally/intranasally, initially, at the onset of migraine

Pediatric dosage

Children below 12 years

• Safety and efficacy not established
• Children above 12 years
• 2.5 mg orally/intranasally, initially, at the onset of migraine

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Zolmitriptan include:

• pain or tightness in the throat or chest,
• dry mouth,
• upset stomach,
• heavy feeling anywhere in the body,
• drowsiness,
• feeling tired, and
• flushing (warmth, redness, or tingly feeling)

Serious side effects of Zolmitriptan include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat
• a feeling of tightness in the jaw, neck, throat, or chest,
• fast or pounding heartbeats,
• dizziness,
• sudden and severe stomach pain,
• bloody diarrhea,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sweating,
• agitation,
• hallucinations,
• fever,
• fast heart rate,
• overactive reflexes,
• nausea,
• vomiting,
• diarrhea,
• loss of coordination, and
• fainting.

Rare side effects of Zolmitriptan include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Zolmitriptan has severe interactions with the following drugs:
  • almotriptan
  • bromocriptine
  • cabergoline
  • dihydroergotamine
  • dihydroergotamine intranasal
  • eletriptan
  • ergoloid mesylates
  • ergotamine
  • frovatriptan
  • methylergonovine
  • naratriptan
  • procarbazine
  • rizatriptan
  • sumatriptan
  • sumatriptan intranasal
• Zolmitriptan has serious interactions with the following drugs:
  • citalopram
  • cyclobenzaprine
  • desvenlafaxine
  • dolasetron
  • granisetron
  • isocarboxazid
  • linezolid
  • lorcaserin
  • methylene blue
  • netupitant/palonosetron
  • ondansetron
  • ozanimod
  • palonosetron
  • phenelzine
  • rasagiline
  • tedizolid
  • tranylcypromine
  • vilazodone
  • vortioxetine
• Zolmitriptan has moderate interactions with at least 86 other drugs.
• Zolmitriptan has minor interactions with the following drugs:
  • duloxetine
  • escitalopram
  • fluoxetine
  • milnacipran
  • nefazodone
  • paroxetine
  • sertraline
  • trazodone
  • venlafaxine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• History of myocardial infarction
• Ischemic or vasospastic artery disease, including Prinzmetal variant angina or other significant underlying cardiovascular disease
• Uncontrolled HTN
• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
• Peripheral vascular disease
• Ischemic bowel disease
• Not indicated for basilar or hemiplegic migraine
• Do not use concurrently with or within 2 weeks of using MAO Inhibitors
• Recent use (ie, within 24 hr) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide)
• History of stroke
• Transient ischemic attack, or history of hemiplegic or basilar migraine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zolmitriptan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zolmitriptan?”

Cautions

• Little added benefit with 5 mg orally dose compared with 2.5 mg
• Coronary artery vasospasm, myocardial infarction, transient ischemia, ventricular tachycardia/fibrillation, cardiac arrest, and death reported with the use
• In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional doses
• Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of these drugs for above 10 days/month) may lead to exacerbation of headache (medication overuse headache)
• As with other 5-HT1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur that are not cardiac in origin
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred with 5-HT1 agonists, including some fatalities
• Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, exclude other potentially serious neurological conditions; the drug is contraindicated in patients with a history of stroke or transient ischemic attack
• May cause noncoronary vasospastic reactions (eg, peripheral vascular ischemia, GI vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome
• Significant elevation in blood pressure, including hypertensive crisis reported in patients with and without a history of hypertension; monitor blood pressure in patients receiving therapy
• Potentially life-threatening serotonin syndrome may occur, particularly during combined use with SSRIs (eg, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRIs (e.g., venlafaxine, duloxetine); discontinue therapy if serotonin syndrome suspected
• Partial vision loss and blindness (transient and permanent) were reported with 5-HT1 agonists
• Use caution in elderly patients, who are more likely to have underlying cardiovascular disease and hepatic or renal impairment; cardiovascular evaluation is recommended in patients with other cardiovascular risk factors before initiation of therapy
• Therapy is indicated for acute treatment of migraine headache; not for migraine prophylaxis
• Use for 10 or more days per month may lead to worsening of headaches; detoxification of patients, including withdrawal of overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary
• Phenylalanine can be harmful to patients with phenylketonuria (PKU). orally disintegrating tablets contain phenylalanine (a component of aspartame); each 2.5 mg and 5 mg orally disintegrating tablet contains 2.81 and 5.62 mg of phenylalanine, respectively; tablets do not contain phenylalanine
• Coronary artery disease
  • Not for administration to patients with risk factors for coronary artery disease (CAD), including hypercholesterolemia, obesity, smoking, diabetes, menopause, males above 40 years, or strong family history of CAD
  • Patients at risk should have CAD ruled out before initiating therapy
  • The first dose should be given in the healthcare provider's office if cardiovascular evaluation is satisfactory
  • Cardiovascular status should be evaluated periodically in all patients receiving therapy
  • For patients with multiple cardiovascular risk factors with negative cardiovascular evaluation, consider administering the first dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration; for such patients, consider periodic cardiovascular evaluation in intermittent long-term users of the drug

Pregnancy and Lactation

• There are no adequate data on the developmental risk associated with the use in pregnant women; in reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures
• Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy
• Lactation
  • There are no data on the presence of drugs or metabolites in human milk, effects on the breastfed infant, or milk production; in rats, oral dosing with zolmitriptan resulted in levels in milk up to 4 times that in maternal plasma
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition