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# Jazz Pharma NDA for Sleep Disorders Under Review
- URL: https://www.fdaweb.com/jazz-pharma-nda-for-sleep-disorders-under-review/
- Published: 2018-03-02T12:00:00.000Z
- Updated: 2026-09-14T23:26:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140891

FDA has accepted for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigationaldrug for treating excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The agency has set a user fee review action target date of 12/20.

The submission includes data from a Phase 3 clinical program that includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with sleep apnea (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5) in treating excessive sleepiness in patients with narcolepsy or sleep apnea.

Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize it from Aerial Biopharma.