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Cautions

Contraindications

• Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).
• Coronary artery vasospasm (e.g., Prinzmetal variant angina).
• Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).
• Cerebrovascular syndromes (e.g., stroke syndromes, TIAs).
• Hemiplegic or basilar migraine.
• Treatment within previous 24 hours with another 5-HT₁ receptor agonist or an ergot alkaloid. (See Specific Drugs under Interactions.)
• Concurrent or recent (within 2 weeks) treatment with an MAO-A inhibitor. (See Specific Drugs under Interactions.)
• Known sensitivity to zolmitriptan or any ingredient in the formulation.

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.

Cardiac Effects

Risk of coronary vasospasm, myocardial ischemia and/or infarction, life-threatening cardiac rhythm disturbances, and death with use of 5-HT₁ receptor agonists.

Use not recommended in patients with symptomatic Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other accessory pathway conduction disorders.

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician's office, possibly followed by ECG) unless patient previously received the drug.

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.

Patients with symptoms suggestive of angina after receiving zolmitriptan should be evaluated for the presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT₁ receptor agonists.

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT₁ receptor agonists. Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic bowel syndrome, Raynaud's syndrome) occur following administration.

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension.

Increases in mean pulmonary artery pressure observed following administration of a 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).

Local Effects

Possible local irritation or soreness after intranasal administration. Adverse effects perceived in nasopharynx, occasionally severe, usually resolve within 1 hour.

No clinically important nasopharyngeal changes observed by examination following repeated use for up to 1 year’s duration.

General Precautions

Ocular Effects

Possible accumulation of zolmitriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.

Phenylketonuria

Each 2.5- or 5-mg Zomig-ZMT^® orally disintegrating tablet contains aspartame, which is metabolized in GI tract to provide 2.81 or 5.62 mg of phenylalanine, respectively. Conventional tablets do not contain aspartame.

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Caution advised if zolmitriptan is used.

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.

Geriatric Use

Pharmacokinetic profile similar to that in younger adults. However, patients >65 years of age were excluded from clinical studies; safety and efficacy not established.

Hepatic Impairment

Substantial elevation of BP observed in some patients with moderate-to-severe hepatic impairment following 10-mg oral dose. Use with caution in patients with hepatic impairment; BP monitoring and dosage adjustment recommended.

Common Adverse Effects

Dizziness, paresthesia, hyperesthesia, neck/throat/jaw/chest symptoms (e.g., pain, tightness, pressure, heaviness), nausea, somnolence, warm or cold sensation, asthenia, dry mouth, dyspepsia; with intranasal therapy, also nasal cavity disorder/discomfort, unusual taste.