Solriamfetol safe, effective for excessive sleepiness

In patients with narcolepsy or obstructive sleep apnea, solriamfetol safely and effectively curbed excessive sleepiness over a long-term period, according to a poster presentation at SLEEP 2018, the Annual Meeting of the Associated Professional Sleep Societies.

“If approved by the FDA, solriamfetol would offer patients the first new chemical entity for the treatment of excessive sleepiness in narcolepsy and OSA in the U.S. in nearly 10 years,” Jed Black, MD, senior vice president of Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor at Stanford Center for Sleep Sciences and Medicine, said in a press release.

The researchers enrolled 643 patients with excessive sleepiness due to narcolepsy (n = 226) or OSA (n = 417). Participants received solriamfetol for a 2-week titration phase, as well as a 50-week maintenance phase.

A subgroup of participants (n = 280) were enrolled into a 2-week placebo-controlled randomized withdrawal after about 6 months of treatment. Of these participants, 141 received placebo and 139 received solriamfetol.

During the randomized withdrawal phase, participants receiving solriamfetol showed consistent improvement, while those who switched to placebo had worse outcomes. The least squares mean change in Epworth Sleepiness Scale score was lower in the solriamfetol group than the placebo group (1.6 vs. 5.3; least squares mean difference = –3.7; 95% CI –4.8 to –2.65).

Significantly more participants who switched to placebo reported more severe excess sleepiness than those receiving solriamfetol. In addition, participants receiving solriamfetol showed sustained reductions in mean Epworth Sleepiness Scale scores and improvements on the Patient and Clinician Global Impression of Change scales for up to 1 year.

The most common serious adverse events associated with solriamfetol were headache, nausea, insomnia, nasopharyngitis, dry mouth and anxiety. One or more serious treatment-emergent adverse events were experienced by 4.2% of participants. – by Alaina Tedesco

Reference:

Malhotra A, et al. A long-term safety and maintenance of efficacy study of solriamfetol (JZP-110) in the treatment of excessive sleepiness in subjects with narcolepsy or obstructive sleep apnea. Presented at: SLEEP, the Annual Meeting of the Associated Professional Sleep Societies; June 2-6, 2018; Baltimore.

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.