Sumatriptan and Naproxen for Treatment of Migraine in Adolescents

Marcia L. Buck, PharmD, FCCP, FPPAG


Pediatr Pharm. 2015;21(6) 

In This Article


It is estimated that 8 to 23% of adults and adolescents 11 years of age and older suffer from migraines.[1,2] Over the past decade, the serotonin 5-HT1B,1D receptor agonists (triptans) have become a mainstay in the acute management of migraines in adults. While often used off-label in adolescents and older children, several randomized placebo-controlled clinical trials have failed to demonstrate significant benefit in relieving migraine symptoms.[3–6] Analysis of these trials identified a high placebo-response rate in this population, with 30–50% of placebo-treated adolescents citing pain relief within 2 hours. Nonrandomization techniques have been used in more recent studies to identify early placebo responders, help to reduce the placebo response rate to expected values (5–10%) and providing for a more accurate interpretation of the effect of treatment.[4]

Until this year, only two drugs in this class had been approved by the Food and Drug Administration (FDA) for pediatric patients. The first, almotriptan received an indication in 2009 for acute management of migraine in children 12 to 17 years of age and older. The second, rizatriptan, was given an expanded indication in 2011 to include treatment of migraine in children 6 to 17 years of age. On May 15, 2015, the FDA announced an extension of the original 2008 approval of the combination of sumatriptan and naproxen sodium (Treximet®) to include acute management of migraines in children 12 years of age and older, giving prescribers a third option.[7,8]