Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials

Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives

“…48 A dose-related effect was shown in this metaanalysis: mean difference in MWT at 75 mg was 5.79 (95% CI: −0.39 to 11.96), p=0.066; at 150 mg was 9.48 (95% CI: 6.48 to12.49), p<0.001; and at 300 mg was 11.80 (95% CI: 9.33 to14.28), p<0.001. 48 These results indicate that the mean difference in MWT was significant at the 150 and 300 mg doses, but not at the 75 mg dose. The mean difference in ESS at 75 mg was −1.89 (95% CI: −3.08 to −0.7), p=0.002; at 150 mg it was −4.23 (95% CI: −5.27 to −3.19), p<0.001; and at 300 mg it was −4.66 (95% CI: −5.71 to −3.60), p <0.001).…”

“…The mean difference in ESS at 75 mg was −1.89 (95% CI: −3.08 to −0.7), p=0.002; at 150 mg it was −4.23 (95% CI: −5.27 to −3.19), p<0.001; and at 300 mg it was −4.66 (95% CI: −5.71 to −3.60), p <0.001). 48 These results show that at these various doses of solriamfetol (75 mg, 150 mg, 300 mg), ESS scores were significantly reduced. The difference in mean ESS scores was much greater between the 75 and 150 mg doses than between the 150 and 300 mg doses; the lesser difference between the 150 and 300 mg doses might represent a ceiling effect of these therapeutic doses.…”

“…In this meta-analysis, a subgroup analysis compared the narcolepsy patients to the OSA patients, and there was no statistical difference in the mean MWT latencies between the 2 groups. 48 An overall significant improvement of PGI-C and CGI-C by 40.2% and 36.5% was also reported. 48 This meta-analysis excluded data from the long-term trial 42 to avoid duplication of results.…”

“…[37][38][39][40][41]48 Results of the meta-analysis indicated the overall mean difference for MWT was 9.93 min (95% CI: 8.25 to 11.61) and the mean difference of ESS score was −4.44 (95% CI: −5.50 to −3.38), both favoring solriamfetol over placebo. 48 A dose-related effect was shown in this metaanalysis: mean difference in MWT at 75 mg was 5.79 (95% CI: −0.39 to 11.96), p=0.066; at 150 mg was 9.48 (95% CI: 6.48 to12.49), p<0.001; and at 300 mg was 11.80 (95% CI: 9.33 to14.28), p<0.001. 48 These results indicate that the mean difference in MWT was significant at the 150 and 300 mg doses, but not at the 75 mg dose.…”

“…48 This meta-analysis excluded data from the long-term trial 42 to avoid duplication of results. 48 In doing so, it did not capture the long-term benefits in reducing ES to a normal level (ESS <10) in the post-hoc analysis, as previously discussed, nor did it reflect the differences in the long-term responses between the narcolepsy and OSA patients. 42,48…”