Claims for Patent: 12,090,126

Summary for Patent: 12,090,126

Title:	Methods of administering solriamfetol to lactating women
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.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Malta Ltd
Application Number:	US18/491,311
Patent Claims:	1. A method of treating excessive daytime sleepiness in a lactating human mother, with an infant at risk of adverse events from the mother's excessive daytime sleepiness, and who wishes to breastfeed the infant, said method comprising: a) determining the Epworth Sleepiness Scale (ESS) total score of the mother and if the mother experiences sleep attacks while caring for the infant, b) providing the mother having an ESS total score of 15 or greater and who experiences sleep attacks while caring for the infant a starting dose of solriamfetol of 37.5 mg once daily if the excessive daytime sleepiness is associated with obstructive sleep apnea, or 75 mg once daily if the excessive daytime sleepiness is associated with narcolepsy, and doubling the dose at intervals of at least 3 days up to 150 mg once daily; and c) feeding the infant breast milk obtained from the lactating mother at least about 3.5 hours after administration of the solriamfetol to the lactating mother, thereby avoiding exposing the infant to the maximum concentrations of solriamfetol in the breast milk, wherein the median Tmax of solriamfetol excreted in the breast milk is approximately 1.1 hours, and wherein the daily infant dose of solriamfetol is about 0.3 mg or lower after a 150 mg dose, about 0.15 mg or lower after a 75 mg dose, and about 0.08 mg or lower after a 37.5 mg dose. 2. The method of claim 1, wherein the lactating mother experiences a reduction in the ESS total score of 5 or more. 3. The method of claim 1, wherein the lactating mother experiences a reduction in the frequency of sleep attacks while holding the infant. 4. The method of claim 1, wherein the lactating mother experiences a reduction in the frequency of sleep attacks while feeding the infant. 5. The method of claim 1, wherein the lactating mother experiences a reduction in the frequency of sleep attacks while nursing the infant. 6. The method of claim 1, wherein the lactating mother experiences a reduction in the frequency of automatic movements while caring for the infant. 7. The method of claim 1, wherein the infant is not fed breast milk obtained within at least about 5 hours of the mother receiving an oral once-daily dose of solriamfetol. 8. The method of claim 1, wherein the infant does not experience agitation due to exposure to the solriamfetol in the breast milk. 9. The method of claim 1, wherein the infant does not experience insomnia due to exposure to the solriamfetol in the breast milk. 10. The method of claim 1, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol in the breast milk. 11. The method of claim 1, wherein the solriamfetol is excreted in the breast milk with a milk to plasma AUC ratio of approximately 2:1. 12. The method of claim 1, wherein an elimination half-life of the solriamfetol excreted in the breast milk is approximately 5 hours. 13. The method of claim 1, wherein the lactating mother is from about 1 day to about 24 months postpartum. 14. The method of claim 1, wherein the lactating mother is from about 10 days to about 52 weeks postpartum. 15. The method of claim 1, wherein the lactating mother is between the ages of 18 and 45 years.