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Indication and Important Safety Considerations

• ZOMIG (zolmitriptan) is indicated for the acute treatment of migraine with or without aura in adults, where a clear diagnosis of migraine has been established
• ZOMIG, like other compounds in this class, should not be given to patients with coronary artery disease (CAD) or for whom unrecognized CAD is predicted by risk factors or to patients with uncontrolled hypertension
• ZOMIG should not be administered to patients with hemiplegic or basilar migraine
• ZOMIG should not be given to patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks
• The development of a potentially life-threatening serotonin syndrome may occur with triptans, including ZOMIG treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
• There are no adequate and well-controlled studies in pregnant women; therefore ZOMIG should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• The most common adverse events in clinical trials for ZOMIG and ZOMIG-ZMT were paresthesia, asthenia, nausea, dizziness, pain, chest or neck tightness or heaviness, somnolence, and warm sensation
• The most common adverse events in clinical trials for ZOMIG Nasal Spray were unusual taste, paresthesia, hyperesthesia, and dizziness
• Phenylketonuric patients should be informed that ZOMIG-ZMT 2.5 mg and ZOMIG-ZMT 5 mg contain 2.81 and 5.62 mg of phenylalanine (a component of aspartame), respectively