Zomig-ZMT Orally Disintegrating Tablets

Zomig is a prescription medicine approved to treat migraine headaches in adults. Only your doctor can determine if Zomig is right for you. Zomig is not for the prevention of migraines or for the treatment of hemiplegic or basilar migraines. Zomig is not for other types of headaches.

See below for complete Approved Use and Important Safety Information for Zomig.

In a clinical study, Zomig-ZMT Orally Disintegrating Tablets 2.5 mg provided migraine headache relief at 2 hours for many patients. Your results may vary.

Zomig-ZMT migraine headache response*

In a clinical study, 231 adult patients were treated with Zomig-ZMT Orally Disintegrating Tablets 2.5 mg and 239 adult patients were treated with a placebo (sugar pill) for moderate or severe migraine headaches. The graph below shows the percentage of patients with moderate or severe headache who improved to mild headache or no pain 2 hours after treatment.

*Headache response was defined as a moderate or severe headache improving to mild headache or no pain.

  • In another study, 329 adult patients took Zomig-ZMT 5 mg and 341 adult patients took a placebo (sugar pill) for moderate or severe migraine headache. At 2 hours, 59% of those taking Zomig-ZMT 5 mg and 31% of those taking placebo had improvement to mild headache or no pain.
  • In the only study that directly compared Zomig 2.5 mg and Zomig 5 mg, the conventional tablet formulation was used. This study found that there was little added benefit from the larger 5-mg dose, but that side effects were generally increased at 5 mg. Patients should, therefore, be started on a dose 2.5 mg or lower. It is not recommended that you break Zomig-ZMT Orally Disintegrating Tablets. A dose lower than 2.5 mg can be achieved by using the conventional Tablets formulation and manually breaking the scored 2.5 mg tablet in half. If you are not sure of this, ask your doctor. Please be certain that you take Zomig exactly as prescribed by your doctor.

For a safe way to carry your Zomig Tablets or Zomig-ZMT Orally Disintegrating Tablets, call for your Free Container: 1-877-99-IMPAX (46729), Monday through Friday, 8 am – 6 pm ET, excluding holidays.

Important Safety Information for Zomig
  • Do not take Zomig if you
    • Have heart disease or a history of heart disease
    • Have uncontrolled high blood pressure
    • Have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)
    • Have or have had a stroke or problems with your blood circulation
    • Have serious liver problems
    • Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications
    • Have taken monoamine oxidase (MAO) inhibitors for depression or other conditions within the last 2 weeks
    • Are allergic to Zomig or any of its ingredients
    If you are not sure about any of the above, ask your doctor.
  • Tell your doctor about all the medicines you take or plan to take, including prescription and nonprescription medicines, supplements, and herbal remedies.
  • In very rare cases, patients taking Zomig may experience serious side effects such as heart attacks, increases in blood pressure, stroke, life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body, or serious allergic reactions. In extremely rare cases, patients have died from these side effects. Call your doctor right away if you have any of the following problems after taking Zomig: severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away; shortness of breath or wheezing; sudden or severe stomach pain; bloody diarrhea; hives; tongue, mouth, lip, or throat swelling; problems seeing; slurring of speech; or unusual weakness or numbness
  • Tell your doctor if you know that you have any of the following: risk factors for heart disease like high cholesterol, diabetes, smoking, obesity (overweight), menopause, or a family history of heart disease or stroke.
  • Some people who take Zomig may have a reaction called serotonin syndrome which can be life-threatening. In particular this reaction may occur when Zomig is used together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (confusion, hallucinations, agitation, coma), fast heartbeat, changes in blood pressure, feeling faint, fever, sweating, muscle spasm, trouble walking, nausea, vomiting, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking Zomig
  • Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Your doctor will decide if you can take ZOMIG with your other medicines
  • Tell your doctor if you are sensitive to phenylalanine, which can be found in the artificial sweetener aspartame. ZOMIG-ZMT contains phenylalanine
  • Tell your doctor if you are pregnant, planning to become pregnant, breast feeding, planning to breast feed, or not using effective birth control
  • The safety and effectiveness of Zomig have not been established in patients under 18 years of age or patients over 65 years of age
  • The most common side effects reported by patients in clinical trials for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets include tingling sensation; weakness; nausea; dizziness; pain, tightness, pressure or heaviness such as in the chest, throat, neck, or jaw; drowsiness; and warm sensation. The most common side effects reported by patients in clinical studies for Zomig Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of the nasal cavity; and dry mouth
Approved Use for Zomig

Zomig is a prescription medicine approved to treat migraine headaches in adults. Only your doctor can determine if Zomig is right for you.

Zomig should only be used where a clear diagnosis of migraine has been established. For a given migraine attack, if you do not respond to the first dose of Zomig, then your doctor will need to determine if you really have a migraine headache before you take a second dose. Zomig is not for the prevention of migraines or for the treatment of hemiplegic or basilar migraines (if you are not sure about this, ask your doctor). Zomig is not for other types of headaches, including cluster headache.

This is not a complete summary of safety information. Please discuss the full Prescribing Information with your doctor.

Click here to see the full Prescribing Information for Zomig Tablets and Zomig-ZMT Orally Disintegrating TabletsOpens in new window (PDF — 194KB)

Click here to see the full Prescribing Information for Zomig Nasal SprayOpens in new window (PDF — 122KB)

Click here to see Important Zomig Product Information for PatientsOpens in new window (PDF — 480KB)

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You should not use this information for diagnosing a health problem or disease. You should always consult with a physician or other health care provider for your, or your loved ones', personal medical needs if you have questions or to make health care decisions.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Please read the full Prescribing Information and discuss it with your doctor or health care professional.