Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea

Frederick Vinckenbosch; Jerryll Asin; Nicolaas de Vries; Patty E. Vonk; Claire E. H. M. Donjacour; Gert Jan Lammers; Sebastiaan Overeem; Hennie Janssen; Grace Wang; Dan Chen; Lawrence P. Carter; Kefei Zhou; Annemiek Vermeeren; Johannes G. Ramaekers

doi:10.1002/hup.2845

Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea

Frederick Vinckenbosch^*, Jerryll Asin, Nicolaas de Vries, Patty E. Vonk, Claire E. H. M. Donjacour, Gert Jan Lammers, Sebastiaan Overeem, Hennie Janssen, Grace Wang, Dan Chen, Lawrence P. Carter, Kefei Zhou, Annemiek Vermeeren, Johannes G. Ramaekers

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA).

METHODS: Eligible participants were aged 21-75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency <30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days]) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on-road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint.

RESULTS: Solriamfetol significantly reduced SDLP at 2 (n = 34; least squares mean difference, -1.1 cm; 95% CI, -1.85, -0.32; p = 0.006) and 6 hours postdose (n = 32; least squares mean difference, -0.8 cm; 95% CI, -1.58, -0.03; p = 0.043). Two hours postdose, 4 placebo-treated and 1 solriamfetol-treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment-emergent adverse events included headache, nausea, and insomnia.

CONCLUSIONS: Solriamfetol 300 mg/day significantly improved on-the-road driving performance in participants with EDS associated with OSA.

Original language	English
Article number	e2845
Number of pages	11
Journal	Human psychopharmacology
Volume	37
Issue number	6
Early online date	28 May 2022
DOIs	https://doi.org/10.1002/hup.2845
Publication status	Published - Nov 2022

Keywords

ADULTS
ORAL JZP-110 ADX-N05
PREVALENCE
QUALITY-OF-LIFE
RISK
STANDARD-DEVIATION
Sunosi
WAKEFULNESS
excessive daytime sleepiness
obstructive sleep apnoea
on-the-road driving
solriamfetol

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Cite this

Vinckenbosch, F., Asin, J., de Vries, N., Vonk, P. E., Donjacour, C. E. H. M., Lammers, G. J., Overeem, S., Janssen, H., Wang, G., Chen, D., Carter, L. P., Zhou, K., Vermeeren, A., & Ramaekers, J. G. (2022). Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea. Human psychopharmacology, 37(6), Article e2845. https://doi.org/10.1002/hup.2845

@article{70c3c6efa7754ceb8e0de98b8510b2f0,

title = "Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea",

abstract = "OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA).METHODS: Eligible participants were aged 21-75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency <30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days]) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on-road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint.RESULTS: Solriamfetol significantly reduced SDLP at 2 (n = 34; least squares mean difference, -1.1 cm; 95% CI, -1.85, -0.32; p = 0.006) and 6 hours postdose (n = 32; least squares mean difference, -0.8 cm; 95% CI, -1.58, -0.03; p = 0.043). Two hours postdose, 4 placebo-treated and 1 solriamfetol-treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment-emergent adverse events included headache, nausea, and insomnia.CONCLUSIONS: Solriamfetol 300 mg/day significantly improved on-the-road driving performance in participants with EDS associated with OSA.",

keywords = "ADULTS, ORAL JZP-110 ADX-N05, PREVALENCE, QUALITY-OF-LIFE, RISK, STANDARD-DEVIATION, Sunosi, WAKEFULNESS, excessive daytime sleepiness, obstructive sleep apnoea, on-the-road driving, solriamfetol",

author = "Frederick Vinckenbosch and Jerryll Asin and {de Vries}, Nicolaas and Vonk, {Patty E.} and Donjacour, {Claire E. H. M.} and Lammers, {Gert Jan} and Sebastiaan Overeem and Hennie Janssen and Grace Wang and Dan Chen and Carter, {Lawrence P.} and Kefei Zhou and Annemiek Vermeeren and Ramaekers, {Johannes G.}",

note = "{\textcopyright} 2022 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons Ltd.",

year = "2022",

month = nov,

doi = "10.1002/hup.2845",

language = "English",

volume = "37",

journal = "Human psychopharmacology",

issn = "1099-1077",

number = "6",

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Vinckenbosch, F, Asin, J, de Vries, N, Vonk, PE, Donjacour, CEHM, Lammers, GJ, Overeem, S, Janssen, H, Wang, G, Chen, D, Carter, LP, Zhou, K, Vermeeren, A & Ramaekers, JG 2022, 'Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea', Human psychopharmacology, vol. 37, no. 6, e2845. https://doi.org/10.1002/hup.2845

TY - JOUR

T1 - Effects of solriamfetol on on-the-road driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnoea

AU - Vinckenbosch, Frederick

AU - Asin, Jerryll

AU - de Vries, Nicolaas

AU - Vonk, Patty E.

AU - Donjacour, Claire E. H. M.

AU - Lammers, Gert Jan

AU - Overeem, Sebastiaan

AU - Janssen, Hennie

AU - Wang, Grace

AU - Chen, Dan

AU - Carter, Lawrence P.

AU - Zhou, Kefei

AU - Vermeeren, Annemiek

AU - Ramaekers, Johannes G.

PY - 2022/11

Y1 - 2022/11

N2 - OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA).METHODS: Eligible participants were aged 21-75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency <30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days]) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on-road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint.RESULTS: Solriamfetol significantly reduced SDLP at 2 (n = 34; least squares mean difference, -1.1 cm; 95% CI, -1.85, -0.32; p = 0.006) and 6 hours postdose (n = 32; least squares mean difference, -0.8 cm; 95% CI, -1.58, -0.03; p = 0.043). Two hours postdose, 4 placebo-treated and 1 solriamfetol-treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment-emergent adverse events included headache, nausea, and insomnia.CONCLUSIONS: Solriamfetol 300 mg/day significantly improved on-the-road driving performance in participants with EDS associated with OSA.

AB - OBJECTIVE: To evaluate the impact of solriamfetol, a dopamine and norepinephrine reuptake inhibitor, on on-the-road driving in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA).METHODS: Eligible participants were aged 21-75 years with OSA and EDS (Maintenance of Wakefulness Test mean sleep latency <30 minutes and Epworth Sleepiness Scale score ≥10). Participants were randomised 1:1 to solriamfetol (150 mg/day [3 days], then 300 mg/day [4 days]) or placebo for 7 days, before crossover to the other treatment paradigm. On Day 7 of each period, standardised on-road driving tests occurred (2 and 6 hours postdose). Standard deviation of lateral position (SDLP) was the primary endpoint.RESULTS: Solriamfetol significantly reduced SDLP at 2 (n = 34; least squares mean difference, -1.1 cm; 95% CI, -1.85, -0.32; p = 0.006) and 6 hours postdose (n = 32; least squares mean difference, -0.8 cm; 95% CI, -1.58, -0.03; p = 0.043). Two hours postdose, 4 placebo-treated and 1 solriamfetol-treated participants had incomplete driving tests; 6 hours postdose, 7 and 3 participants, respectively, had incomplete tests. Common treatment-emergent adverse events included headache, nausea, and insomnia.CONCLUSIONS: Solriamfetol 300 mg/day significantly improved on-the-road driving performance in participants with EDS associated with OSA.

KW - ADULTS

KW - ORAL JZP-110 ADX-N05

KW - PREVALENCE

KW - QUALITY-OF-LIFE

KW - RISK

KW - STANDARD-DEVIATION

KW - Sunosi

KW - WAKEFULNESS

KW - excessive daytime sleepiness

KW - obstructive sleep apnoea

KW - on-the-road driving

KW - solriamfetol

U2 - 10.1002/hup.2845

DO - 10.1002/hup.2845

M3 - Article

C2 - 35633275

SN - 1099-1077

VL - 37

JO - Human psychopharmacology

JF - Human psychopharmacology

IS - 6

M1 - e2845

ER -