Claims for Patent: 11,771,667

Summary for Patent: 11,771,667

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:	US18/176,816
Patent Claims:	1. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising: orally administering solriamfetol to the mother at a once-daily dose of about 150 mg; and feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother; wherein the daily infant dose of solriamfetol is reduced to about 0.3 mg or lower; and wherein the potential for adverse events in the infant due to the solriamfetol is decreased. 2. The method of claim 1, wherein the adverse event is agitation, insomnia, anorexia, or reduced weight gain. 3. The method of claim 1, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 4. The method of claim 1, where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work disorder, major depression, or Parkinson's disease. 5. The method of claim 1, wherein the lactating mother is from 1 day to 24 months postpartum. 6. The method of claim 1, wherein the lactating mother is from 10 days to 12 months postpartum. 7. The method of claim 1, wherein the lactating mother is between the ages of 18 and 45 years. 8. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising: orally administering solriamfetol to the mother at a once-daily dose of about 75 mg; and feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother; wherein the daily infant dose of solriamfetol is reduced to about 0.15 mg or lower; and wherein the potential for adverse events in the infant due to the solriamfetol is decreased. 9. The method of claim 8, wherein the adverse event is agitation, insomnia, anorexia, or reduced weight gain. 10. The method of claim 8, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 11. The method of claim 8, where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work disorder, major depression, or Parkinson's disease. 12. The method of claim 8, wherein the lactating mother is from 1 day to 24 months postpartum. 13. The method of claim 8, wherein the lactating mother is from 10 days to 12 months postpartum. 14. The method of claim 8, wherein the lactating mother is between the ages of 18 and 45 years. 15. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising: orally administering solriamfetol to the mother at a once-daily dose of about 150 mg; and feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother; wherein the daily infant dose of solriamfetol is reduced to about 0.3 mg or lower; and wherein the exposure of the infant to the solriamfetol from the breast milk is decreased. 16. The method of claim 15, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 17. The method of claim 15, where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work disorder, major depression, or Parkinson's disease. 18. The method of claim 15, wherein the lactating mother is from 1 day to 24 months postpartum. 19. The method of claim 15, wherein the lactating mother is from 10 days to 12 months postpartum. 20. The method of claim 15, wherein the lactating mother is between the ages of 18 and 45 years. 21. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising: orally administering solriamfetol to the mother at a once-daily dose of about 75 mg; and feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother; wherein the daily infant dose of solriamfetol is reduced to about 0.15 mg or lower; and wherein the exposure of the infant to the solriamfetol from the breast milk is decreased. 22. The method of claim 21, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 23. The method of claim 21, where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work disorder, major depression, or Parkinson's disease. 24. The method of claim 21, wherein the lactating mother is from 1 day to 24 months postpartum. 25. The method of claim 21, wherein the lactating mother is from 10 days to 12 months postpartum. 26. The method of claim 21, wherein the lactating mother is between the ages of 18 and 45 years.