Clinical Drug Investigation

, Volume 39, Issue 4, pp 411–418 | Cite as

Sufentanil 30 µg Sublingual Tablet: A Review in Acute Pain

  • Emma D. DeeksEmail author
Adis Drug Evaluation


The sufentanil 30 μg sublingual tablet (hereafter referred to as the sufentanil ST) is approved in the EU for acute moderate to severe pain in adults (Dzuveo™) and in the USA for acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (Dsuvia™). It is a single-strength tablet housed in a single-dose applicator (which may minimize the likelihood of dosing errors) and is strictly for use in medically supervised/monitored settings. It is administered by a healthcare professional and has a minimum re-dose interval of 1 h and no drug delivery setup requirements. In placebo-controlled or noncomparative phase 2 or 3 trials, the sufentanil ST provided effective analgesia for adults with moderate to severe acute pain due to surgery or trauma/injury, reducing the intensity of pain within 15–30 min after the first dose and maintaining analgesic benefit over the 2–24 h study periods. Such short-term use of the sufentanil ST was also generally well tolerated. Studies directly comparing the sufentanil ST with other opioids in terms of efficacy, tolerability, usability and cost effectiveness would be beneficial, as would analyses of its abuse potential, given sufentanil is considerably more potent than fentanyl or morphine. In the meantime, current data indicate that the sufentanil ST is a noninvasive, fast-acting, opioid formulation for managing moderate to severe acute pain in medically supervised/monitored settings that may be of particular use when oral or intravenous opioid analgesia is not possible/feasible.



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

Compliance with Ethical Standards


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

Conflict of interest

Emma Deeks is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.


  1. 1.
    Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17(2):131–57.CrossRefGoogle Scholar
  2. 2.
    Samcam I, Papa L. Acute pain management in the emergency department. In: Prostran M, editor. Pain management: IntechOpen; 2016.Google Scholar
  3. 3.
    Keating L, Smith S. Acute pain in the emergency department: the challenges. Rev Pain. 2011;5(3):13–7.CrossRefGoogle Scholar
  4. 4.
    Pain Free Hospital. Guidelines for pain management in emergency & trauma department. Accessed 10 Jan 2019.
  5. 5.
    Best Practice Advocacy Centre New Zealand. The principles of managing acute pain in primary care. 2018. Accessed 10 Jan 2019.
  6. 6.
    World Health Organization. WHO’s cancer pain ladder for adults. 2015. Accessed 10 Jan 2019.
  7. 7.
    Minkowitz HS, Candiotti K. The role of sublingual sufentanil nanotabs for pain relief. Expert Opin Drug Deliv. 2015;12(5):845–51.CrossRefGoogle Scholar
  8. 8.
    Minkowitz HS. A review of sufentanil and the sufentanil sublingual tablet system for acute moderate to severe pain. Pain Manag. 2015;5(4):237–50.CrossRefGoogle Scholar
  9. 9.
    Porela-Tiihonen S, Kokki M, Kokki H. Sufentanil sublingual formulation for the treatment of acute, moderate to severe postoperative pain in adult patients. Expert Rev Neurother. 2017;17(2):101–11.CrossRefGoogle Scholar
  10. 10.
    Frampton JE. Sublingual sufentanil: a review in acute postoperative pain. Drugs. 2016;76(6):719–29.CrossRefGoogle Scholar
  11. 11.
    European Medicines Agency. Dzuveo: EU summary of product characteristics. 2018. Accessed 25 Feb 2019.
  12. 12.
    US Food and Drug Administration. Dsuvia (sufentanil sublingual tablet 30 mcg): US prescribing information. 2018. Accessed 25 Feb 2019.
  13. 13.
    Mather LE. Opioids - a pharmacologist’s delight! Clin Exp Pharmacol Physiol. 1995;22(11):833–6.CrossRefGoogle Scholar
  14. 14.
    Lotsch JR. Pharmacokinetic-pharmacodynamic modeling of opioids. J Pain Symptom Manag. 2005;29(5):S90–103.CrossRefGoogle Scholar
  15. 15.
    Willsie SK, Evashenk MA, Hamel LG, et al. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015;37(1):145–55.CrossRefGoogle Scholar
  16. 16.
    Didonato K, Palmer P. Pharmacokinetics of a single dose of sufentanil sublingual tablet 30 mcg vs intravenous sufenta® 30 mcg (50 mcg/ml) infused over 1 minute in healthy volunteers [abstract no. 142]. Pain Med. 2017;18(3):585.Google Scholar
  17. 17.
    Fisher DM, Chang P, Wada DR, et al. Pharmacokinetic properties of a sufentanil sublingual tablet intended to treat acute pain. Anesthesiology. 2018;128(5):943–52.CrossRefGoogle Scholar
  18. 18.
    Minkowitz HS, Leiman D, Melson T, et al. Sufentanil sublingual tablet 30 mcg for the management of pain following abdominal surgery: a randomized, placebo-controlled, phase-3 study. Pain Pract. 2017;17(7):848–58.CrossRefGoogle Scholar
  19. 19.
    Singla NK, Muse DD, Evashenk MA, et al. A dose-finding study of sufentanil sublingual microtablets for the management of postoperative bunionectomy pain. J Trauma Acute Care Surg. 2014;77(3):S198–203.CrossRefGoogle Scholar
  20. 20.
    Miner JR, Rafique Z, Minkowitz HS, et al. Sufentanil sublingual tablet 30 mcg for moderate-to-severe acute pain in the ED. Am J Emerg Med. 2018;36(6):954–61.CrossRefGoogle Scholar
  21. 21.
    Hutchins JL, Leiman D, Minkowitz HS, et al. An open-label study of sufentanil sublingual tablet 30 mcg in patients with postoperative pain. Pain Med. 2018;19(10):2058–68.CrossRefGoogle Scholar
  22. 22.
    Minkowitz H, Melson T, Leiman D, et al. Comprehensive efficacy and integrated safety results from the late-phase clinical program of the Sufentanil sublingual tablet 30 mcg [poster]. In: 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting. 2017Google Scholar
  23. 23.
    Miner JR, Melson TI, Leiman D, et al. Pooled phase III safety analysis of sufentanil sublingual tablets for short-term treatment of moderate-to-severe acute pain. Pain Manag. 2019.
  24. 24.
    Faculty of Pain Medicine. Opioids and acute pain management. 2019. Accessed 10 Jan 2019.
  25. 25.
    The College of Emergency Medicine. Best practice guideline. Management of pain in adults. 2014. Accessed 10 Jan 2019.
  26. 26.
  27. 27.
    Volkow ND, McLellan AT. Opioid abuse in chronic pain—misconceptions and mitigation strategies. N Engl J Med. 2016;374(13):1253–63.CrossRefGoogle Scholar
  28. 28.
    Krans B. Should FDA have approved ‘super opioid’ that’s stronger than fentanyl? 2018. Accessed 10 Jan 2019.
  29. 29.
    Hlavinka E. AcelRx pushes safety analysis on powerful new opioid—but bulk of data uses unapproved sufentanil dosing [media release]. 8 Jan 2019.

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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