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Author: Admin | 2025-04-28
Driving or operating machinery until they are reasonably certain that buspirone treatment does not affect them adversely. While formal studies of the interaction of the drug with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid ethanol ingestion while taking buspirone.[28501]The safety and efficacy profiles of buspirone in geriatric adults are similar to those in younger adults; however, greater sensitivity of some older patients cannot be ruled out; a lower initial dosage is recommended in geriatric patients.[28501] The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs). When buspirone is being used to manage behavior, stabilize mood, or treat a psychiatric disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines. Dosages and durations of treatment used in the geriatric adult should be in accordance with prescribing labels, published literature recommendations, and expert guidelines.[60742]Clinical studies related to the use of buspirone in pregnancy and subsequent outcomes are limited. In a prospective analysis of data from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications, 68 women who gave birth to 72 infants reported use of buspirone during the first trimester of pregnancy. No major malformations were reported in any infants who were exposed to buspirone during the first trimester. Additional well-controlled studies with larger populations of pregnant patients are needed to further assess for potential risks related to buspirone exposure in pregnancy. No teratogenic effects have been observed in animal studies when using approximately 30 times the maximum recommended human dose (MRHD); however, animal reproduction studies are not always predictive of human response. The effects of buspirone during labor and delivery are unknown.[69030] [28501] [62732]Buspirone and its metabolites are excreted in the milk of lactating rats. Limited information indicates that maternal doses of buspirone up to 45 mg/day produce low levels in human milk and adverse events have not been reported; however, there are no data on the long-term use of buspirone during lactation and the prescribing label recommends avoidance if clinically possible. Consider if an alternative would be appropriate. A pooled analysis found that maternal use of paroxetine usually produced undetectable or low drug concentrations in infant serum; this agent may be an option when initiating chronic therapy for generalized anxiety disorder (GAD) in a breast-feeding individual. For acute anxiety requiring a benzodiazepine, short-acting agents such as oxazepam or lorazepam may be considered; however, the breastfed infant should be monitored for sedation, feeding difficulties, or other signs of toxicity which would indicate the need to discontinue the benzodiazepine.[28501] [45642] [46229] [61269] [62732] [69031]Buspirone is not approved by the FDA for any indication in infants, children, or adolescents. Guidelines do not recommend buspirone as a first-line treatment for anxiety disorders in pediatric patients. However, buspirone has been used clinically in children and adolescents 6 years of age and older. Efficacy for anxiety disorders is uncertain due to inconsistent data; however, the
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