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# Lilly’s Reyvow Approved for Migraines
- URL: https://www.fdaweb.com/lillys-reyvow-approved-for-migraines/
- Published: 2019-10-11T12:00:00.000Z
- Updated: 2026-09-15T01:55:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145231

FDA has approved Eli Lilly’s Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults. Approval was based on data from two placebo-controlled clinical trials involving almost 3,200 adults with a history of migraines. “In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo,” an [agency release](http://s2027422842.t.en25.com/e/es?s=2027422842&e=264643&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=d6383faff98e4d4e90e4987ecba43e36&elqaid=9862&elqat=1&ref=fdaweb.com) says. FDA notes that 22% of patients in the studies were taking a preventive medication for migraines.

FDA says the approval includes a warning about driving while taking Reyvow. Patients are advised not to drive or operate machinery for at least eight hours after taking the drug. “The drug causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants,” it says.