Frequently Asked Questions
ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older.1
Limitations of Use:
Use ZOMIG Nasal Spray only after a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG Nasal Spray treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG Nasal Spray is administered to treat any subsequent attacks. ZOMIG Nasal Spray is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG Nasal Spray have not been established for cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.
Learn about migraine relief with ZOMIG Nasal SprayZOMIG Nasal Spray is contraindicated in patients with1:
- Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal’s angina
- Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at higher risk of stroke
- Peripheral vascular disease (PVD)
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide)
- Concurrent administration of an MAO-A inhibitor or recent discontinuation of a MAO-A inhibitor (that is within 2 weeks)
- Known hypersensitivity to ZOMIG Nasal Spray (angioedema and anaphylaxis seen)
The majority of patients had headache relief at 2 hours, which was the primary endpoint. Of patients using ZOMIG Nasal Spray 5 mg, 11.5% achieved headache response within 15 minutes vs 5.4% for placebo (P=.02). The recommended starting dose is 2.5 mg.1,2
Learn about migraine relief with ZOMIG Nasal SprayIn patients ages ≥12 years1
- Recommended starting dose: 2.5 mg
- Maximum single dose: 5 mg
- If migraine has not resolved by 2 hours after taking ZOMIG, or returns after a transient improvement, another dose may be administered at least 2 hours after the previous dose
- The maximum daily dose should not exceed 10 mg in any 24-hour period
- Not recommended in patients with moderate to severe hepatic impairment
- The safety of ZOMIG in the treatment of an average of more than 4 headaches in a 30-day period has not been established
- If co-administered with cimetidine, limit the maximum single dose of ZOMIG to 2.5 mg, not to exceed 5 mg in any 24-hour period
Nasal sprays provide a range of benefits that are uniquely important to migraine patients, such as:
- No need to swallow if they have dysphagia1,3
- Can be used despite migraine-associated nausea3,4
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.1
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.1
Learn about migraine relief with ZOMIG Nasal SprayYour patients will need to ask their insurance provider to help find out if they are covered for ZOMIG Nasal Spray. If they do not have coverage, they may be eligible to get assistance.
ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older.
Limitations of Use:
Use ZOMIG Nasal Spray only after a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG Nasal Spray treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG Nasal Spray is administered to treat any subsequent attacks. ZOMIG Nasal Spray is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG Nasal Spray have not been established for cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.
Important Safety Information
Contraindications:
- History of coronary artery disease (CAD) or coronary artery vasospasm or other significant underlying cardiovascular disease
- Wolff-Parkinson-White Syndrome or arrhythmias associated with 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 ergot-type medication
- Current or recent (past 2 weeks) use of monoamine oxidase (MAO)-A inhibitor
- Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray
Warnings and Precautions:
- Myocardial ischemia, myocardial infarction, and Prinzmetal’s Angina: Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors and if satisfactory, consider administrating the first ZOMIG Nasal Spray dose in a medically supervised setting
- Arrhythmias: Discontinue ZOMIG Nasal Spray if these occur
- Sensations of tightness, pain, pressure in the chest, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with 5-HT1 agonists like ZOMIG Nasal Spray and are usually non-cardiac in origin. Perform a cardiac evaluation if these patients are at cardiac risk
- Cerebrovascular events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, some resulting in fatalities. Discontinue ZOMIG Nasal Spray if any of these events occur
- ZOMIG Nasal Spray may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. Discontinue ZOMIG Nasal Spray if any of these events occur
- Transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists
- Overuse of acute migraine drugs may lead to exacerbation of headache. Detoxification may be necessary
- Serotonin syndrome may occur with triptans, including ZOMIG Nasal Spray, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and MAO inhibitors. Discontinue ZOMIG Nasal Spray if serotonin syndrome is suspected
- Increase in blood pressure
Adverse Reactions
- Adults: unusual taste, paresthesia, dizziness, and hyperesthesia
- Pediatrics: unusual taste
Drug Interactions
- Cimetidine: If co-administered, limit the maximum single dose of ZOMIG Nasal Spray to 2.5 mg, not to exceed 5 mg in any 24-hour period
Use in Specific Populations
- Pregnancy: Based on animal data, ZOMIG Nasal Spray may cause fetal harm
- Lactation: There are no data on the presence of zolmitriptan or its metabolites in human milk, effects on milk production, or on the breastfed infant
- Pediatrics: Safety and effectiveness of ZOMIG Nasal Spray in patients <12 years of age have not been established
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.