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Indication and Important Safety Considerations

ZOMIG is indicated for the acute treatment of migraine with or without aura in adults, where a clear diagnosis of migraine has been established.
ZOMIG is not intended for the prophylactic therapy of migraine and is not indicated for the treatment of cluster headache.
• ZOMIG is contraindicated in patients with
• -  Ischemic heart disease (eg, silent ischemia, angina), coronary artery vasospasm, or other significant underlying cardiovascular disease
• -  Cerebrovascular syndromes (eg, history of stroke or TIA)
• -  Peripheral vascular disease (eg, ischemic bowel disease)
• -  Uncontrolled hypertension
• Use of ZOMIG is contraindicated within 24 hours of another 5-HT₁ agonist, ergotamine-containing or ergot-type medication, or within 2 weeks of an MAO-A inhibitor
• ZOMIG should not be administered to patients with hemiplegic or basilar migraine
• It is strongly recommended that ZOMIG not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors without a satisfactory cardiac evaluation
• Patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other accessory cardiac conduction pathways should not receive ZOMIG
• Development of potentially life-threatening serotonin syndrome may occur with triptans particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
• Phenylketonuric patients should be informed that ZOMIG-ZMT^® (zolmitriptan) contains phenylalanine
• ZOMIG should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus
• Most common adverse reactions in clinical trials for ZOMIG and ZOMIG-ZMT were paresthesia, asthenia, nausea, dizziness, pain, chest or neck tightness or heaviness, somnolence, and warm sensation
• Most common adverse reactions in clinical trials for ZOMIG Nasal Spray were unusual taste, paresthesia, hyperesthesia, and dizziness