Sunosi Approved to Treat Excessive Daytime Sleepiness
March 21, 2019 – The U.S. FDA has approved Sunosi™ (solriamfetol), manufactured by Jazz Pharmaceuticals, to improve wakefulness in adult patients who experience excessive daytime sleepiness (ESD) associated with narcolepsy or obstructive sleep apnea (OSA).
Approximately 18% of the United States population is estimated to experience ESD, which is a non-specific symptom that can have a variety of causes. It is a prominent characteristic of narcolepsy, a chronic neurological disorder that disrupts the body’s sleep/wake cycle. However, ESD is most often identified in patients who have obstructive sleep apnea, which can cause sleep disruptions when the throat muscles relax and block the airway intermittently during sleep.
In clinical studies, patients treated with Sunosi experienced demonstrated improvements in symptoms compared to placebo from one hour post-administration until the ninth hour post-administration.
Recommended dosing is 75mg for patients with narcolepsy and 37.5mg for patients with OSA. Sunosi should be taken upon waking and at least nine hours before the patient’s planned bedtime due to its potential to interfere with sleep. The dosage can be increased once every three days if needed, but should not exceed 150mg per day.
Jazz Pharmaceuticals plans to launch Sunosi in late June, following controlled substance scheduling of the product by the U.S. Drug Enforcement Administration (DEA). Typically, this process requires 90 days to complete after FDA approval. Pricing plans are not yet available.