Is Lasmiditan approved by the FDA?

Yes, lasmiditan, marketed under the brand name Reyvow, is FDA approved. The FDA granted approval for lasmiditan on October 11, 2019. This approval marked the introduction of lasmiditan as a novel treatment option for the acute management of migraine attacks in adults, with or without aura.

What is Lasmiditan?

Lasmiditan belongs to a class of drugs known as ditans and is used as an abortive medication for migraine attacks, meaning it treats migraines that have already started rather than preventing them. Unlike triptans, which are the standard treatment for migraines and work by constricting blood vessels, lasmiditan does not cause vasoconstriction, making it a suitable option for patients who might have cardiovascular risks.

How Does Lasmiditan Work?

Lasmiditan functions as a serotonin (5-HT)1F receptor agonist. Although the exact mechanism of action is not completely understood, it is believed to work by blocking pain pathways in the brain. This action helps alleviate the symptoms of a migraine attack.

Usage and Administration

Indications:

• Lasmiditan is used for the acute treatment of migraine attacks with or without aura in adults.
• It is not intended for the preventive treatment of migraines.

Dosage:

• The recommended dose of lasmiditan is 50 mg, 100 mg, or 200 mg taken orally as needed.
• Patients should not take more than one dose in a 24-hour period.
• Lasmiditan tablets should be swallowed whole and can be taken with or without food.

Important Safety Information

Precautions:

• Do not drive or operate machinery for at least 8 hours after taking lasmiditan, even if you feel well enough.
• Inform your healthcare provider if you have liver problems, high blood pressure, a low heart rate, or if you are allergic to lasmiditan.
• Lasmiditan is a federally controlled substance (CV) due to potential abuse; therefore, it should be kept in a safe place.

Potential Side Effects: Common side effects of lasmiditan include dizziness, sleepiness, numbness, tiredness, and tingling. More serious side effects can include serotonin syndrome, characterized by mental changes, fast heartbeat, changes in blood pressure, high body temperature, tight muscles, and nausea.

Drug Interactions: Lasmiditan can interact with other medications, particularly those that lower heart rate, increase blood pressure, or cause drowsiness. It can also interact with antidepressants like SSRIs, SNRIs, TCAs, and MAOIs. Always inform your healthcare provider about all the medications you are taking to avoid potential interactions.

Conclusion

Lasmiditan (Reyvow) was FDA approved on October 11, 2019, providing a new option for the acute treatment of migraine attacks in adults. It offers an alternative to triptans, especially for patients who cannot take medications that cause vasoconstriction. As with any medication, it is essential to follow your healthcare provider’s instructions and be aware of potential side effects and interactions.

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