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BACKGROUND: Migraine is a common disabling condition and a burden for the individual, health services, and society. Effective abortive treatments include the triptan and non-steroidal anti-inflammatory classes of drugs. These drugs have different mechanisms of action and combining them may provide better relief. Sumatriptan plus naproxen is now available in combination form for the acute treatment of migraine. OBJECTIVES: To determine the efficacy and tolerability of sumatriptan plus naproxen (administered together as separate tablets or taken as a fixed-dose combination tablet) compared with placebo and other active interventions for the acute treatment of migraine headaches in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE, and EMBASE, together with two online databases ( and for studies to 2 August 2013. We also searched the reference list of included studies and relevant reviews. SELECTION CRITERIA: We included randomised, double-blind, placebo- or active-controlled studies, with at least 10 participants per treatment arm, using sumatriptan plus naproxen to treat a migraine headache episode. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate risk ratio and numbers needed to treat to benefit (NNT) or harm (NNH) compared with placebo or a different active treatment. MAIN RESULTS: We included 12 studies using sumatriptan 85 mg or 50 mg plus naproxen 500 mg to treat attacks of mild, moderate, or severe pain intensity: 3663 participants received combination treatment, 3682 placebo, 964 sumatriptan, and 982 naproxen. No studies were considered to be at high risk of bias for any of the criteria evaluated.Overall, the combination was better than placebo for pain-free and headache relief responses. At two hours, the NNT for pain-free response was 3.1 when the baseline pain was mild (50% response with sumatriptan plus naproxen compared with 18% with placebo), and 4.9 when baseline pain was moderate or severe (28% with sumatriptan plus naproxen compared with 8% with placebo) (RR 3.65 (95% CI 3.0 to 4.5); high quality evidence). Using 50 mg of sumatriptan, rather than 85 mg, in the combination did not significantly change the result. Treating early, when pain was still mild, was significantly better than treating once pain was moderate or severe for pain-free responses at two hours and during the 24 hours post dose. Adverse events were mostly mild or moderate in severity and rarely led to withdrawal; they were more common with the combination than with placebo.Where the data allowed direct comparison, combination treatment was superior to either monotherapy, but adverse events were less frequent with naproxen than sumatriptan. AUTHORS' CONCLUSIONS: Combination treatment was effective in the acute treatment of migraine headaches. The effect was greater than for the same dose of either sumatriptan or naproxen alone, but additional benefits over sumatriptan alone are not large. More participants achieved good relief when medication was taken early in the attack, when pain was still mild. Adverse events were more common with the combination and sumatriptan alone than with placebo or naproxen alone.

Original publication




Journal article


Cochrane Database Syst Rev

Publication Date



Acute Disease, Adult, Anti-Inflammatory Agents, Non-Steroidal, Drug Combinations, Drug Therapy, Combination, Humans, Migraine Disorders, Naproxen, Randomized Controlled Trials as Topic, Serotonin 5-HT1 Receptor Agonists, Sumatriptan