Methods of administering solriamfetol to lactating women
AssigneeAxsome Malta Ltd.
InventorHerriot Tabuteau
Life of this patent
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Abstract
Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.
Claims30
A method of avoiding exposing an infant of a nursing human mother being treated with solriamfetol to peak concentrations of solriamfetol excreted in breast milk, the method comprising not feeding the infant breast milk obtained within at least about 3.5 hours of the mother receiving an oral once-daily dose of about 150 mg solriamfetol, wherein the median Tmax of solriamfetol excreted in the breast milk is approximately 1.1 hour, wherein a daily infant dose of solriamfetol is reduced to about 0.3 mg or lower.
A method of avoiding exposing an infant of a nursing human mother being treated with solriamfetol to peak concentrations of solriamfetol excreted in breast milk, the method comprising not feeding the infant breast milk obtained within at least about 3.5 hours of the mother receiving an oral once-daily dose of about 75 mg solriamfetol, wherein the median Tmax of solriamfetol excreted in the breast milk is approximately 1.1 hour, wherein a daily infant dose of solriamfetol is reduced to about 0.15 mg or lower.
Dependencies are inferred from the claim text.