Common early onset treatment-emergent adverse events (TEAEs) associated with solriamfetol include headache, anorexia, and nausea in patients with obstructive sleep apnea (OSA) and narcolepsy, according to research presented at World Sleep 2019, held September 20 to 25, 2019, in Vancouver, Canada.
Researchers conducted a post-hoc analysis of 2 pivotal 12-week trials of solriamfetol therapy in patients with OSA (n=474) and narcolepsy (n=236). Participants with OSA were randomly assigned to either placebo (OSA, n=119; narcolepsy, n=59) or solriamfetol at 37.5 mg, whereas patients with narcolepsy were randomly assigned to either placebo of solriamfetol at 75 mg, 150 mg, or 300 mg (doses ≤150 mg: OSA, n=237; narcolepsy, n=118; all doses: OSA, n=355; narcolepsy, n=177). The researchers calculated the incidence of any new occurrence or worsening severity over time for common, early-onset TEAEs that occurred in ≥5% of participants in any solriamfetol dose group.
The most common early onset TEAEs during week 1 (≤150 mg/all doses) in the OSA study included headache ( 5.1%/5.1%), decreased appetite (4.2%/5.6%), jitteriness (3.0%/3.7%), nausea (2.5%/3.7%), anxiety (2.1%/3.9%), and insomnia (1.3%/3.1%). Incidence of these events were highest during the first week of treatment and subsequently decreased over time. A total of 11 of 25 TEAE-related discontinuations on solriamfetol were related to the most frequent early onset TEAEs between weeks 3 and 9. Across ≤150 mg/all doses of solriamfetol, the median durations of common early onset TEAEs were 8/5.5 days for headache, 18/57 days for decreased appetite, 4/4 days for feeling jittery, 8/10 days for nausea, 36/26 days for anxiety, and 21/8.5 days for insomnia.
During week 1 of the narcolepsy study, the most common early onset TEAEs in ≤150 mg/all doses of solriamfetol included headache (8.5%/11.9%), decreased appetite (5.9%/7.9%), nausea (4.2%/5.7%), and dry mouth (4.2%/5.1%). Across ≤150 mg and all doses of solriamfetol, the median durations of common early onset TEAEs included 2/2 days for headache, 80/79 days for decreased appetite, 5/5 days for nausea, and 82/80 days for dry mouth. Overall, common early-onset TEAEs were responsible for the discontinuation of treatment in 11% of participants.
In a final remark, researchers noted that these findings “may inform clinician and patient expectations regarding the type and duration of common early-onset TEAEs associated with solriamfetol.”
Disclosure: This study was funded and sponsored by Jazz Pharmaceuticals.
Rosenberg R, Thorpy MJ, Dauvilliers Y, et al. Incidence and duration of common adverse events in 2 solriamfetol phase 3 studies for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. Poster presented at: World Sleep 2019; September 20-25, 2019; Vancouver, Canada;