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Clinical Trials

Zomig (zolmitriptan)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved February 2001

Specific Treatments:


Therapeutic Areas

General Information

Zomig-ZMT is an orally disintegrating tablet that has been approved for treatment of acute migraines in adults. The tablet has a pleasant orange flavor and dissolves quickly on the tongue. This easy delivery method makes the product convenient to take at anytime, anywhere.

Zomig-ZMT has a novel, dual-action pharmacological profile that has demonstrated both peripheral and central activity in the brain, working together to provide rapid, long-lasting relief of migraine pain.

Migraine is a common disorder worldwide and estimates suggest that 10 to 15 percent of the population in developed countries are affected at some time during their lives. The prevalence of migraine reaches a peak during sufferers' most productive years, between the ages of 25 and 55. The condition often causes disability and adversely affects quality of life.

Clinical Results

The effectiveness of Zomig-ZMT (zolmitriptan) as a treatment for acute migraine was established in five randomized, double-blind, placebo-controlled trials. The first was conducted in a clinical setting, while the other four were outpatient studies. Adult subjects received Zomig-ZMT in dosages of 1 mg, 2.5mg, or 5mg. They were instructed to administer the drug when suffering from moderate to severe migraine pain.

Subjects were assessed one, two, and four hours after dosing. Response was defined as reduction in severity of headache pain from moderate or severe, to mild or no pain. In all studies, subjects who received the two higher doses of Zomig-ZMT achieved a significantly greater response compared to those receiving the lowest dosage or placebo. Of the two studies evaluating the 1 mg dosage, only one reported subjects in the drug group achieving a significantly greater response than those in the placebo group. (from Zomig-ZMT Prescribing Information)

Trials demonstrated efficacy of Zomig-ZMT to be significant within one hour of dosing, with some patients experiencing relief within 30 minutes. One tablet provided relief up to 24 hours in the majority of subjects.

Side Effects

Adverse events associated with the use of zolmitriptan may include (but are not limited to) the following:

  • Chest pain
  • Tightness in throat
  • Feelings of tingling, heat, or pressure

Mechanism of Action

Zomig-ZMT (zolmitriptan) is an oral selective 5-hydroxytryptamine (5-HT) receptor agonist that binds to human recombinant 5-HT and 5-HT receptors. It is thought that migraine symptoms are due to local cranial vasodilatation and/or to the release of sensory neuropeptides through nerve endings in the trigeminal system. The therapeutic effects of zolmitriptan are most likely due to the agonistic effects at the 5-HT recptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

After zolmitriptan is absorbed through oral administration, its peak plasma concentrations occur in two hours. (from Zomig-ZMT Prescribing Information)

Additional Information

For additional information on Zomig-ZMT, please visit Zomig or AstraZeneca.

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