Classes
DEA Class; Rx
Common Brand Names; Zomig, Zomig Rapimelt, Zomig-ZMT
- Serotonin 5-HT-Receptor Agonists;
- Antimigraine Agents
Description
Serotonin agonist for migraine treatment
Available in oral and nasal spray formulas
Similar to sumatriptan, but unlike sumatriptan, zolmitriptan can penetrate the CNS to act centrally within the trigeminovascular system
Indications
Indicated for acute treatment of migraine with or without aura
Contraindications
Hypersensitivity
History of myocardial infarction
Ischemic or vasospastic artery disease, including Prinzmetal variant angina or other significant underlying cardiovascular disease
Uncontrolled HTN
Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
Peripheral vascular disease
Ischemic bowel disease
Not indicated for basilar or hemiplegic migraine
Do not use concurrently with or within 2 wk of using MAO Inhibitors
Recent use (ie, within 24 hr) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide)
History of stroke
Transient ischemic attack, or history of hemiplegic or basilar migraine
Adverse Effects
- Dizziness (6-10%)
- Neck/throat/jaw pain (4-10%)
- Parasthesia (5-9%)
- Nausea (4-9%)
- Weakness (3-9%)
- Somnolence (5-8%)
- Warm/cold sensation (5-7%)
- Xerostomia (3-5%)
- Chest pain (2-4%)
- Diaphoresis (3%)
- Pain (2-3%)
- Dyspepsia (1-3%)
- Dysphagia (2%)
- Myasthenia (2%)
- Palpation (2%)
- Vertigo (2%)
- Hypoesthesia (1-2%)
- Myalgia (1-2%)
Warnings
Little added benefit with 5 mg PO dose compared with 2.5 mg
Coronary artery vasospasm, myocardial infarction, transient ischemia, ventricular tachycardia/fibrillation, cardiac arrest, and death reported with use
In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional doses
Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)
As with other 5-HT1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur that are not cardiac in origin
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred with 5-HT1 agonists, including some fatalities
Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, exclude other potentially serious neurological conditions; drug is contraindicated in patients with a history of stroke or transient ischemic attack
May cause noncoronary vasospastic reactions (eg, peripheral vascular ischemia, GI vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome
Significant elevation in blood pressure, including hypertensive crisis reported in patients with and without history of hypertension; monitor blood pressure in patients receiving therapy
Potentially life-threatening serotonin syndrome may occur, particularly during combined use with SSRIs (eg, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRIs (eg, venlafaxine, duloxetine); discontinue therapy if serotonin syndrome suspected
Partial vision loss and blindness (transient and permanent) reported with 5-HT1 agonists
Use caution in elderly patients, who are more likely to have underlying cardiovascular disease and hepatic or renal impairment; cardiovascular evaluation recommended in patients with other cardiovascular risk factors prior to initiation of therapy
Therapy is indicated for acute treatment of migraine headache; not for migraine prophylaxis
Pregnancy and Lactation
There are no adequate data on the developmental risk associated with the use in pregnant women
There are no data on presence of drug or metabolites in human milk, effects on the breastfed infant, or on milk production
Maximum Dosage
5 mg per single dose or 10 mg per 24 hours PO or intranasally. The safety of treating an average of more than 3 headaches with the tablets or 4 headaches with the nasal spray in a 30-day period has not been established.
5 mg per single dose or 10 mg per 24 hours PO or intranasally. The safety of treating an average of more than 3 headaches with the tablets or 4 headaches with the nasal spray in a 30-day period has not been established.
5 mg per single dose or 10 mg per 24 hours intranasally. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Safety and efficacy of oral dosage forms have not been established.
>= 12 years: 5 mg per single dose or 10 mg per 24 hours intranasally. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Safety and efficacy of oral dosage forms have not been established.
< 12 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Zolmitriptan
tablet
- 2.5mg (scored)
- 5mg
oral disintegrating tablet
- 2.5mg
- 5mg
intranasal spray
- 2.5mg/single-use device
- 5mg/single-use device