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Author: Admin | 2025-04-28
Indications/DosageLabeledanxietygeneralized anxiety disorderOff-Label† Off-label indicationFor the treatment of generalized anxiety disorder (GAD) or for the short-term relief of the symptoms of anxietyOral dosageAdults7.5 mg PO twice daily, initially. May increase the dose by 5 mg/day every 2 to 3 days as needed. Usual dose: 20 to 30 mg/day. Max: 60 mg/day. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.[28501]Adolescents†2.5 to 5 mg PO twice daily, initially. May increase the dose by 5 mg/day every 3 to 7 days as needed. Max: 60 mg/day. Guidelines do not consider buspirone a first-line option for the treatment of anxiety in adolescents due to inconsistent clinical trial results; however, small open-label studies have shown benefit. Two placebo-controlled 6-week trials for generalized anxiety disorder (GAD) in pediatric patients 6 to 17 years of age reported no significant differences in efficacy between buspirone and placebo. In a small study of pediatric patients with anxiety disorder, doses of 5 to 30 mg PO twice daily were well-tolerated in adolescents and improved symptoms over 4 to 6 weeks of treatment.[62490] [67322] [70655] Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.[28501]Children† 6 to 12 years2.5 to 5 mg PO twice daily, initially. May increase the dose by 5 mg/day every 3 to 7 days as needed. Usual dose: 10 to 15 mg/day. Max: 60 mg/day. Guidelines do not consider buspirone a first-line option for the treatment of anxiety in children due to inconsistent clinical trial results; however, small open-label studies have shown benefit. Two placebo-controlled 6-week trials for generalized anxiety disorder (GAD) in pediatric patients 6 to 17 years of age reported no significant differences in efficacy between buspirone and placebo. In a small study of pediatric patients with anxiety disorder, doses of 5 to 7.5 mg PO twice daily were well-tolerated in children 6 to 12 years of age and improved symptoms over 4 to 6 weeks of treatment. However, the study indicated that higher dosages may be poorly tolerated in children less than 12 years of age.[62490] [67322] [70655] Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.[28501]Therapeutic Drug MonitoringMaximum Dosage LimitsAdults60 mg/day PO.Geriatric60 mg/day PO.AdolescentsSafety and efficacy have not been established.ChildrenSafety and efficacy have not been established.InfantsNot indicated.Patients with Hepatic Impairment DosingBuspirone is not recommended for use in patients with severe hepatic impairment.[28501]Patients with Renal Impairment DosingCrCl less than 30 mL/minute: Buspirone is not recommended for use in patients with severe renal impairment or renal failure.[28501]Intermittent hemodialysisBuspirone is not recommended in patients with renal failure.[28501]† Off-label indicationRevision Date: 02/15/2025, 01:43:00 AMReferences28501 - Buspirone tablets package insert. Parsippany, NJ: Teva Pharmaceuticals; 2023 Mar.62490 - Salazar DE, Frackiewicz EJ, Dockens R, et al. Pharmacokinetics and tolerability of buspirone during oral administration to children and adolescents with anxiety disorder and normal healthy adults. J Clin Pharmacol 2001;41:1351-8.67322 - Walter HJ, Bukstein OG, Abright AR, et al. Clinical practice guideline for
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