Section 02 · Monograph
Sumatriptan-naproxen
Reviewed Nov 2026FDA label
TreximetTriptan + NSAID
- Forms
- Tab: 85/500mg
- Dose
- 1 tab PRN, may repeat after 2h (max 2 tabs/day)
- MOA
- 5-HT1B/1D agonism + COX inhibition
Black Box Warning
- NSAID component: risk of serious cardiovascular thrombotic events (MI, stroke); contraindicated in the setting of CABG surgery
- NSAID component: risk of serious GI bleeding, ulceration and perforation, which can be fatal
Indications
- Acute treatment of migraine with or without aura in adults and pediatric patients 12 years and olderFDA-labeled
Mechanism of Action
- Sumatriptan: 5-HT1B/1D agonism causing cranial vasoconstriction and reduced neuropeptide release
- Naproxen: COX inhibition reducing prostaglandin-mediated inflammation and pain
Full Dosing
Adult / usual
- One tablet (sumatriptan 85mg/naproxen sodium 500mg) at migraine onset; may repeat after at least 2 hours; maximum 2 tablets in 24 hours
- Safety of treating more than 5 migraines in 30 days has not been established
Contraindications
- Ischemic or vasospastic coronary artery disease, uncontrolled hypertension, hemiplegic or basilar migraine
- Another 5-HT1 agonist or ergot within 24 hours; MAOI within 2 weeks
- History of asthma, urticaria or allergic reaction to aspirin or NSAIDs
- Perioperative CABG pain; severe hepatic impairment; hypersensitivity
Drug Interactions
- SSRIs/SNRIs: serotonin syndrome risk
- Anticoagulants and aspirin: bleeding risk
- ACE inhibitors and diuretics: reduced efficacy and renal risk with NSAIDs
- Raises lithium levels
Adverse Effects
- Dizziness, somnolence, paresthesia, chest or throat tightness
- GI upset and bleeding
- Serotonin syndrome
- Medication overuse headache
Monitoring Parameters
- Cardiovascular risk assessment and blood pressure
- Renal and hepatic function and CBC with chronic use
- Headache frequency
Pregnancy & Lactation
- Avoid at 20 weeks gestation and later (NSAID fetal renal dysfunction/oligohydramnios) and in the third trimester
- Present in milk; monitor infants