Skip to main content
SpringerLink
Log in

Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea

  • Adis Drug Evaluation
  • Published:
CNS Drugs Aims and scope Submit manuscript

Abstract

Solriamfetol (SUNOSI®) is an oral selective dopamine and norepinephrine reuptake inhibitor approved in the EU and the USA for improving wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnoea (OSA). In phase III studies, 12 weeks’ therapy with solriamfetol within the recommended dosage range for narcolepsy (75 mg or 150 mg once daily) or OSA (37.5 mg, 75 mg or 150 mg once daily) provided early and sustained reductions in excessive sleepiness and improvements in wakefulness relative to placebo. These effects were generally sustained through 52 weeks. The drug’s effectiveness in adults with EDS associated with narcolepsy is supported by results from real-world studies. Solriamfetol demonstrated a consistent safety and tolerability profile across clinical studies, with commonly reported adverse reactions generally occurring within 2 weeks of treatment initiation and mostly resolving within 2 weeks. Thus, solriamfetol represents a useful treatment option for adults with EDS associated with narcolepsy or OSA.

Plain Language Summary

Excessive daytime sleepiness (EDS) is a common condition in which an individual is unable to stay awake during periods when they typically would be awake. Dopamine and norepinephrine are among the chemical messengers involved in sleep–wake regulation. Solriamfetol (SUNOSI®), a selective dopamine and norepinephrine reuptake inhibitor, is a once-daily oral treatment approved in the EU and the USA for improving wakefulness in adults with EDS associated with narcolepsy or obstructive sleep apnoea (OSA). In such patients, solriamfetol reduced excessive sleepiness and improved wakefulness compared with placebo over 12 weeks. Onset was rapid and generally sustained through 52 weeks. The safety and tolerability profile of solriamfetol was consistent over the short and longer term; the most common adverse reactions were headache, decreased appetite, nausea, anxiety and insomnia in adults with narcolepsy and nausea and decreased appetite in those with OSA. Thus, solriamfetol represents a useful treatment option for adults with EDS associated with narcolepsy or OSA.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Pérez-Carbonell L, Mignot E, Leschziner G, et al. Understanding and approaching excessive daytime sleepiness. Lancet. 2022;400(10357):1033–46.

    Article  PubMed  Google Scholar 

  2. Lal C, Weaver TE, Bae CJ, et al. Excessive daytime sleepiness in obstructive sleep apnea: mechanisms and clinical management. Ann Am Thorac Soc. 2021;18(5):757–68.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Ono T, Takenoshita S, Nishino S. Pharmacologic management of excessive daytime sleepiness. Sleep Med Clin. 2022;17(3):485–503.

    Article  PubMed  Google Scholar 

  4. Baladi MG, Forster MJ, Gatch MB, et al. Characterization of the neurochemical and behavioral effects of solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor. J Pharmacol Exp Ther. 2018;366(2):367–76.

    Article  CAS  PubMed  Google Scholar 

  5. TMC Pharma (EU) Ltd. Sunosi (solriamfetol) film-coated tablets: EU summary of product characteristics. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/sunosi. Accessed 6 Sep 2023.

  6. Axsome Therapeutics Inc. SUNOSI (solriamfetol) tablets, for oral use: US prescribing information. 2023. https://www.fda.gov/. Accessed 6 Sep 2023.

  7. Markham A. Solriamfetol: first global approval. Drugs. 2019;79(7):785–90.

    Article  CAS  PubMed  Google Scholar 

  8. Deeks ED, Heo YA. Solriamfetol in excessive daytime sleepiness: a profile of its use. Drugs Ther Perspect. 2020;36(5):173–80.

    Article  Google Scholar 

  9. Zomorodi K, Chen D, Lee L, et al. A randomized, double-blind, placebo- and positive-controlled, 4-period crossover study of the effects of solriamfetol on QTcF intervals in healthy participants. Clin Pharmacol Drug Dev. 2021;10(4):404–13.

    Article  CAS  PubMed  Google Scholar 

  10. Carter LP, Henningfield JE, Wang YG, et al. A randomized, double-blind, placebo-controlled, crossover study to evaluate the human abuse liability of solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor. J Psychopharmacol. 2018;32(12):1351–61.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Zomorodi K, Chen D, Lee L, et al. Single-dose pharmacokinetics and safety of solriamfetol in participants with normal or impaired renal function and with end-stage renal disease requiring hemodialysis. J Clin Pharmacol. 2019;59(8):1120–9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Bogan RK, Feldman N, Emsellem HA, et al. Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy. Sleep Med. 2015;16(9):1102–8.

    Article  PubMed  Google Scholar 

  13. Ruoff C, Swick TJ, Doekel R, et al. Effect of oral JZP-110 (ADX-N05) on wakefulness and sleepiness in adults with narcolepsy: a phase 2b study. Sleep. 2016;39(7):1379–87.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Strollo PJ Jr, Hedner J, Collop N, et al. Solriamfetol for the treatment of excessive sleepiness in OSA: a placebo-controlled randomized withdrawal study. Chest. 2019;155(2):364–74.

    Article  PubMed  Google Scholar 

  15. Thorpy MJ, Shapiro C, Mayer G, et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol. 2019;85(3):359–70.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Schweitzer PK, Rosenberg R, Zammit GK, et al. Solriamfetol for excessive sleepiness in obstructive sleep apnea (TONES 3): a randomized controlled trial. Am J Respir Crit Care Med. 2019;199(11):1421–31.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  17. Malhotra A, Shapiro C, Pepin JL, et al. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020;43(2):1–11.

    Article  Google Scholar 

  18. European Medicines Agency. Sunosi (international non-proprietary name solriamfetol): EU assessment report. 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/sunosi. Accessed 6 Sep 2023.

  19. Krystal AD, Benca RM, Rosenberg R, et al. Solriamfetol treatment of excessive daytime sleepiness in participants with narcolepsy or obstructive sleep apnea with a history of depression. J Psychiatr Res. 2022;155:202–10.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Dauvilliers Y, Shapiro C, Mayer G, et al. Solriamfetol for the treatment of excessive daytime sleepiness in participants with narcolepsy with and without cataplexy: subgroup analysis of efficacy and safety data by cataplexy status in a randomized controlled trial. CNS Drugs. 2020;34(7):773–84.

    Article  CAS  PubMed  Google Scholar 

  21. Emsellem HA, Thorpy MJ, Lammers GJ, et al. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020;67:128–36.

    Article  PubMed  Google Scholar 

  22. Schweitzer PK, Mayer G, Rosenberg R, et al. Randomized controlled trial of solriamfetol for excessive daytime sleepiness in OSA: an analysis of subgroups adherent or nonadherent to OSA treatment. Chest. 2021;160(1):307–18.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Weaver TE, Drake CL, Benes H, et al. Effects of solriamfetol on quality-of-life measures from a 12-week phase 3 randomized controlled trial. Ann Am Thorac Soc. 2020;17(8):998–1007.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Schweitzer PK, Strohl KP, Mayer G, et al. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021;17(4):659–68.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Weaver TE, Pepin JL, Schwab R, et al. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021;17(10):1995–2007.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Winter Y, Mayer G, Kotterba S, et al. Solriamfetol real world experience study (SURWEY): initiation, titration, safety, effectiveness, and experience during follow-up for patients with narcolepsy from Germany. Sleep Med. 2023;103:138–43.

    Article  PubMed  Google Scholar 

  27. Malhotra A, Strollo PJ, Pepin J-L, et al. Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. Sleep Med. 2022;100:165–73.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Bassetti CLA, Kallweit U, Vignatelli L, et al. European guideline and expert statements on the management of narcolepsy in adults and children. Eur J Neurol. 2021;28(9):2815–30.

    Article  PubMed  Google Scholar 

  29. Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(9):1881–93.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Gandhi KD, Mansukhani MP, Silber MH, et al. Excessive daytime sleepiness: a clinical review. Mayo Clin Proc. 2021;96(5):1288–301.

    Article  CAS  PubMed  Google Scholar 

  31. Bioprojet Pharma. Wakix (pitolisant) film-coated tablets: EU summary of product characteristics. 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/wakix. Accessed 6 Sep 2023.

  32. UCB Pharma SA. Xyrem (sodium oxybate) 500 mg/mL oral solution: EU summary of product characteristics. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/xyrem. Accessed 6 Sep 2023.

  33. European Medicines Agency. Modafinil-containing medicinal products: annex I, II, III, IV. 2011. https://www.ema.europa.eu/en/medicines/human/referrals/modafinil. Accessed 6 Sep 2023.

  34. Teva Pharmaceuticals USA Inc. PROVIGIL® (modafinil) tablets, for oral use, C-IV: US prescribing information. 2015. https://www.fda.gov/. Accessed 6 Sep 2023.

  35. Jazz Pharmaceuticals Inc. XYREM® (sodium oxybate) oral solution, CIII: US prescribing information. 2023. https://www.fda.gov/. Accessed 6 Sep 2023.

  36. Harmony Biosciences LLC. WAKIX® (pitolisant) tablets, for oral use: US prescribing information. 2022. https://www.fda.gov/. Accessed 6 Sep 2023.

  37. Teva Pharmaceuticals USA Inc. NUVIGIL® (armodafinil) tablets, for oral use, C-IV: US prescribing information. 2017. https://www.fda.gov/. Accessed 6 Sep 2023.

  38. Rosenberg R, Schweitzer PK, Steier J, et al. Residual excessive daytime sleepiness in patients treated for obstructive sleep apnea: guidance for assessment, diagnosis, and management. Postgrad Med. 2021;133(7):772–83.

    Article  PubMed  Google Scholar 

  39. Randerath W, Verbraecken J, de Raaff CAL, et al. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea. Eur Respir Rev. 2021;30(162): 210200.

    Article  PubMed  PubMed Central  Google Scholar 

  40. Epstein LJ, Kristo D, Strollo PJ Jr, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263–76.

    Article  PubMed  Google Scholar 

  41. Bioprojet Pharma. Ozawade (pitolisant) film-coated tablets: EU summary of product characteristics. 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/ozawade. Accessed 6 Sep 2023.

  42. Pitre T, Mah J, Roberts S, et al. Comparative efficacy and safety of wakefulness-promoting agents for excessive daytime sleepiness in patients with obstructive sleep apnea: a systematic review and network meta-analysis. Ann Intern Med. 2023;176(5):676–84.

    Article  PubMed  Google Scholar 

  43. Zhan S, Ye H, Li N, et al. Comparative efficacy and safety of multiple wake-promoting agents for the treatment of excessive daytime sleepiness in narcolepsy: a network meta-analysis. Nat Sci Sleep. 2023;15:217–30.

    Article  PubMed  PubMed Central  Google Scholar 

  44. Chien PY, Kuo CY, Lin MH, et al. Pharmacological interventions for excessive daytime sleepiness in adults with narcolepsy: a systematic review and network meta analysis. J Clin Med. 2022;11(21):6302.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  45. Ronnebaum S, Bron M, Patel D, et al. Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea. J Clin Sleep Med. 2021;17(12):2543–55.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgments

During the peer review process, the manufacturer of solriamfetol were also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Sheridan M. Hoy

Authors
  1. Sheridan M. Hoy
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sheridan M. Hoy.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest

Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethical approval, Consent to participate, Consent to publish, Availability of data and material, Code availability

Not applicable.

Additional information

The manuscript was reviewed by: R. K. Bogan, University of South Carolina School of Medicine, Columbia, SC, USA; R. H. Howland, Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; G. Mayer, Department of Neurology, Philipps-University Marburg, Marburg, Germany; D. N. Neubauer, Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Y. Winter, Department of Neurology, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Johannes Gutenberg-University, Mainz and Department of Neurology, Philipps-University Marburg, Marburg, Germany.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 96 KB)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hoy, S.M. Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea. CNS Drugs 37, 1009–1020 (2023). https://doi.org/10.1007/s40263-023-01040-5

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40263-023-01040-5

Search

Navigation