Zomig Nasal Spray Response Rates

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 or for use in the management of hemiplegic or basilar migraine. Zomig is not indicated for cluster headache.

See below for Complete Indication and Important Safety Information.

Zomig Nasal Spray delivers fast migraine pain relief—it starts working at 15 minutes for some and at 2 hours for many.^4-6

Zomig Nasal Spray—Migraine Headache Response* Rate^4-6

Charlesworth et al

For First Attack

zomig nasal spray migraine response rates

At 30 minutes, the response rate was significantly better than with placebo: 31.5% with Zomig Nasal Spray vs. 12.1% with placebo, increasing to 69.0% at 2 hours vs. 30.8% with placebo (P<.01 vs. placebo for both time points)^4-6
The efficacy of Zomig Nasal Spray 5 mg was further supported by an interim analysis of another similarly designed trial. The 2-hour headache response rates for the first 210 subjects in that study for Zomig 5 mg (n=108) and placebo (n=102) were 70% and 47%, respectively (P=0.0006)⁴

*Defined as a reduction in headache severity from moderate or severe pain to mild or no pain.
^†From a multicenter, randomized, double-blind, double-dummy, placebo-controlled study of Zomig Nasal Spray 5 mg (n=235) vs. placebo (n=226) for the acute treatment of moderate or severe migraines in adults.^4-6

Zomig Nasal Spray—Pain-Free Response^‡ Rate^4,5,7

Charlesworth et al

For First Attack

zomig nasal spray pain free response rates

At 1 hour, the response rate was significantly better than with placebo: 22.0% with Zomig Nasal Spray vs. 3.6% with placebo, increasing to 35.5% at 2 hours vs. 6.4% with placebo, P=.0001 for both time points vs. placebo^4,5,7

^‡Pain-free response was defined as a reduction in headache pain from severe or moderate pain to no pain.
^§From a multicenter, randomized, double-blind, double-dummy, placebo-controlled study of Zomig Nasal Spray 5 mg (n=235) vs. placebo (n=226) for the acute treatment of moderate or severe migraine in adults.^4,5,7

Important Safety Information and Indication

Important Safety Information

Zomig is contraindicated in patients with
- History of coronary artery disease (CAD) or coronary artery vasospasm
- Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent (within 24 hours) use of another 5-HT₁ agonist (eg, another triptan), or an ergotamine-containing medication
- Monamine oxidase (MAO)-A inhibitor used in past 2 weeks
- Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray
Myocardial ischemia, myocardial infarction and Prinzmetal Angina: Perform cardiac evaluation in patients with multiple risk factors and, if satisfactory, administer first dose of ZOMIG in a medically supervised setting
Arrhythmias: Discontinue ZOMIG if these occur
Sensations of tightness, pain and pressure in the chest, throat, neck, and jaw commonly occur after treatment with 5-HT₁ agonists like ZOMIG, and is usually non-cardiac in origin: Perform a cardiac evaluation if these patients are at cardiac risk
Cerebrovascular events, some fatal; non-coronary Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions; and increases in blood pressure (which have been very rarely associated with serious clinical events) have been reported with ZOMIG. Discontinue use of ZOMIG if any of these events occur
Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
Serotonin syndrome may occur with triptans, including ZOMIG, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Discontinue ZOMIG if serotonin syndrome is suspected
Phenylketonuric patients should be informed that Zomig-ZMT^® (zolmitriptan) Orally Disintegrating Tablets contain phenylalanine
The most common adverse reactions (≥5% and > placebo) for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets were neck/throat/jaw pain, dizziness, paresthesia; asthenia; somnolence; warm/cold sensation; nausea; heaviness sensation; and dry mouth
The most common adverse reactions (≥5% and > placebo; in any dosage strength) in clinical trials for Zomig Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness

Indication

Zomig is indicated for the acute treatment of migraine with or without aura in adults. Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache.

Please click here for full Prescribing Information for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets.

Please click here for full Prescribing Information for Zomig Nasal Spray.