Estimation of an Appropriate Dose of Trazodone for Pediatric Insomnia and the Potential for a Trazodone-Atomoxetine Interaction.
Adolescent
Antidepressive Agents, Second-Generation
/ administration & dosage
Atomoxetine Hydrochloride
/ pharmacology
Child
Child, Preschool
Dose-Response Relationship, Drug
Drug Interactions
Humans
Models, Biological
Sleep Initiation and Maintenance Disorders
/ drug therapy
Trazodone
/ administration & dosage
Journal
CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011
Informations de publication
Date de publication:
02 2020
02 2020
Historique:
received:
17
09
2019
accepted:
12
10
2019
pubmed:
7
12
2019
medline:
22
6
2021
entrez:
7
12
2019
Statut:
ppublish
Résumé
There is a paucity of clinical trials for the treatment of pediatric insomnia. This study was designed to predict the doses of trazodone to guide dosing in a clinical trial for pediatric insomnia using physiologically-based pharmacokinetic (PBPK) modeling. Data on the pharmacokinetics of trazodone in children are currently lacking. The interaction potential between trazodone and atomoxetine was also predicted. Doses predicted in the following age groups, with exposures corresponding to adult dosages of 30, 75, and 150 mg once a day (q.d.), respectively, were: (i) 2- to 6-year-old group, doses of 0.35, 0.8, and 1.6 mg/kg q.d.; (ii) >6- to 12-year-old group, doses of 0.4, 1.0, and 1.9 mg/kg q.d.; (iii) >12- to 17-year-old group, doses of 0.4, 1.1, and 2.1 mg/kg q.d. An interaction between trazodone and atomoxetine was predicted to be unlikely. Clinical trials based on the aforementioned predicted dosing are currently in progress, and pharmacokinetic data obtained will enable further refinement of the PBPK models.
Identifiants
pubmed: 31808613
doi: 10.1002/psp4.12480
pmc: PMC7020267
doi:
Substances chimiques
Antidepressive Agents, Second-Generation
0
Atomoxetine Hydrochloride
57WVB6I2W0
Trazodone
YBK48BXK30
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
77-86Informations de copyright
© 2019 ANGELINI S.p.A. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.
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