FDA Approves Drug for Daytime Sleepiness in Those with Sleep Apnea, Narcolepsy

By Amy Orciari Herman

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved solriamfetol (marketed as Sunosi) to treat excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea. The drug is a dual-acting dopamine and norepinephrine reuptake inhibitor, although the manufacturer says its precise mechanism for treating sleepiness is unknown.

Approval was based on data from four randomized trials in over 900 adults, which showed that solriamfetol was superior to placebo in terms of promoting wakefulness. Its effects persisted after 6 months of use, according to the manufacturer.

The most common adverse reactions associated with solriamfetol include headache, nausea, decreased appetite, anxiety, and trouble sleeping.

Solriamfetol can cause elevations in blood pressure and heart rate, so clinicians should check a patient's blood pressure before initiating and during treatment. Additionally, solriamfetol should not be used by those taking a monoamine oxidase inhibitor for depression.