Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial

Abstract

Rationale: Excessive daytime sleepiness in patients with obstructive sleep apnea is associated with substantial burden of illness. Objectives: To assess treatment effects of solriamfetol, a dopamine/norepinephrine reuptake inhibitor, on daily functioning, health-related quality of life, and work productivity in participants with obstructive sleep apnea and excessive daytime sleepiness as additional outcomes in a 12-week phase 3 trial ( www.clinicaltrials.gov identifier NCT02348606). Methods: Participants ( N = 476) were randomized to solriamfetol 37.5, 75, 150, or 300 mg or to placebo. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, and 36-item Short Form Health Survey version 2. A mixed-effects model with repeated measures was used for comparisons with placebo. Results: Demographics, baseline disease characteristics, daily functioning, health-related quality of life, and work productivity were similar across groups. At Week 12, increased functioning and decreased impairment were observed with solriamfetol 150 and 300 mg (mean difference from placebo [95% confidence interval]) on the basis of Functional Outcomes of Sleep Questionnaire total score (1.22 [0.57 to 1.88] and 1.47 [0.80 to 2.13], respectively), overall work impairment (−11.67 [−19.66 to −3.69] and −11.75 [−19.93 to −3.57], respectively), activity impairment (−10.42 [−16.37 to −4.47] and −10.51 [−16.59 to −4.43], respectively), physical component summary (2.07 [0.42 to 3.72] and 1.91 [0.22 to 3.59], respectively), and mental component summary (150 mg only, 2.05 [0.14 to 3.96]). Common adverse events were headache, nausea, decreased appetite, and anxiety. Conclusions: Solriamfetol improved measures of functioning, quality of life, and work productivity in participants with obstructive sleep apnea and excessive daytime sleepiness. Safety was consistent with previous studies. Clinical trial registered with www.clinicaltrials.gov (NCT02348606).

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

“…At baseline, about 49% of participants were employed, and presenteeism (working despite illness, etc., often resulting in reduced productivity) ranged from 43.5% to 47% across treatment groups. 46 , 47 Absenteeism was relatively low at baseline, with patients missing 2.6% to 5% of work per week. Activity impairment outside of work ranged from 37.8% to 44.3%.…”

“…At baseline, about 49% of participants were employed, and presenteeism (working despite illness, etc., often resulting in reduced productivity) ranged from 43.5% to 47% across treatment groups. 46,47 37.8% to 44.3%. 46 At week 12, improved functioning and reduced impairment were observed with solriamfetol 150 mg and 300 mg doses on the basis of improvements in Functional Outcomes of Sleep Questionnaire (FOSQ) total score, overall work impairment, activity impairment, and physical component summary.…”

“…46 At week 12, improved functioning and reduced impairment were observed with solriamfetol 150 mg and 300 mg doses on the basis of improvements in Functional Outcomes of Sleep Questionnaire (FOSQ) total score, overall work impairment, activity impairment, and physical component summary. 46,47 The mental component summary improved only with the 150 mg dose. Presenteeism improved with both 150 mg and 300 mg of solriamfetol.…”

“…Solriamfetol improved measures of functional QOL and work productivity in OSA participants with ES compared to placebo. 46 , 47 Patients were randomized to receive solriamfetol 37.5 mg, 75 mg, 150 mg and 300 mg, or placebo. At baseline, about 49% of participants were employed, and presenteeism (working despite illness, etc., often resulting in reduced productivity) ranged from 43.5% to 47% across treatment groups.…”

A Randomized, Double‐Blind, Placebo‐ and Positive‐Controlled, 4‐Period Crossover Study of the Effects of Solriamfetol on QTcF Intervals in Healthy Participants

“…Solriamfetol is a dopamine and norepinephrine reuptake inhibitor 1 approved in the United States and European Union to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) associated with narcolepsy (75-150 mg/day) or obstructive sleep apnea (OSA; 37.5-150 mg/day). [2][3][4] In vitro studies have shown that the action of solriamfetol differs from that of traditional stimulants (eg, amphetamines) and other reuptake inhibitors (eg, modafinil). 1 Solriamfetol exhibits dual activity at dopamine and norepinephrine transporters and lacks monoamine-releasing effects associated with amphetamines.…”