Clinical pharmacology and dosing regimen optimization of neonatal opioid withdrawal syndrome treatments

Fei Tang, Chee M. Ng, Henrietta S. Bada, Markos Leggas

Research output: Contribution to journalReview articlepeer-review

3 Scopus citations


In this paper, we review the management of neonatal opioid withdrawal syndrome (NOWS) and clinical pharmacology of primary treatment agents in NOWS, including morphine, methadone, buprenorphine, clonidine, and phenobarbital. Pharmacologic treatment strategies in NOWS have been mostly empirical, and heterogeneity in dosing regimens adds to the difficulty of extrapolating study results to broader patient populations. As population pharmacokinetics (PKs) of pharmacologic agents in NOWS become more well-defined and knowledge of patient-specific factors affecting treatment outcomes continue to accumulate, PK/pharmacodynamic modeling and simulation will be powerful tools to aid the design of optimal dosing regimens at the patient level. Although there is an increasing number of clinical trials on the comparative efficacy of treatment agents in NOWS, here, we also draw attention to the importance of optimizing the dosing regimen, which can be arguably equally important at identifying the optimal treatment agent.

Original languageEnglish
Pages (from-to)1231-1249
Number of pages19
JournalClinical and Translational Science
Issue number4
StatePublished - Jul 2021

Bibliographical note

Funding Information:
This work was supported by National Institutes of Health (NIH) grants R01DA043519 and R01DA043519‐02S1.

Publisher Copyright:
© 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.

ASJC Scopus subject areas

  • Neuroscience (all)
  • Biochemistry, Genetics and Molecular Biology (all)
  • Pharmacology, Toxicology and Pharmaceutics (all)


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