Claims for Patent: 12,036,194

Summary for Patent: 12,036,194

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:	US18/491,301
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,036,194
Patent Claims:	1. A method of reducing the exposure to solriamfetol from breast milk, in an infant receiving breast milk from a nursing human mother being treated with a once-daily dose of solriamfetol of about 150 mg for a disorder amenable to treatment with solriamfetol, the method comprising feeding the infant breast milk obtained from the mother at least about 5 hours after administering the solriamfetol to the mother, wherein the exposure to solriamfetol in the infant is reduced by at least about 50% compared to the exposure that would result with feeding the infant breast milk obtained from the mother less than 5 hours after administration of the solriamfetol, and wherein a daily infant dose of solriamfetol is reduced to about 0.3 mg or lower. 2. The method of claim 1, wherein the resulting relative infant dose is about 2% or lower of the once-daily dose of about 150 mg solriamfetol. 3. The method of claim 1, wherein the breast milk is obtained from the mother at least about 7 hours after administering the solriamfetol to the mother. 4. The method of claim 1, wherein the breast milk is obtained from the mother at least about 10 hours after administering the solriamfetol to the mother. 5. The method of claim 1, wherein the infant does not experience agitation due to exposure to the solriamfetol. 6. The method of claim 1, wherein the infant does not experience insomnia due to exposure to the solriamfetol. 7. The method of claim 1, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol. 8. The method of claim 1, wherein the mother is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 9. The method of claim 8, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 10. The method of claim 8, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 11. The method of claim 1, wherein the mother is being treated with solriamfetol to improve wakefulness. 12. The method of claim 1, wherein the mother is from about 1 day to about 24 months postpartum. 13. The method of claim 1, wherein the mother is from about 10 days to about 52 weeks postpartum. 14. The method of claim 1, wherein the mother is between the ages of 18 and 45 years. 15. A method of reducing the exposure to solriamfetol from breast milk, in an infant receiving breast milk from a nursing human mother being treated with a once-daily dose of solriamfetol of about 75 mg for a disorder amenable to treatment with solriamfetol, the method comprising feeding the infant breast milk obtained from the mother at least about 5 hours after administering the solriamfetol to the mother, wherein the exposure to solriamfetol in the infant is reduced by at least about 50% compared to the exposure that would result with feeding the infant breast milk obtained from the mother less than 5 hours after administration of the solriamfetol, and wherein a daily infant dose of solriamfetol is reduced to about 0.15 mg or lower. 16. The method of claim 15, wherein the resulting relative infant dose is about 2% or lower of the once-daily dose of about 75 mg solriamfetol. 17. The method of claim 15, wherein the breast milk is obtained from the mother at least about 7 hours after administering the solriamfetol to the mother. 18. The method of claim 15, wherein the breast milk is obtained from the mother at least about 10 hours after administering the solriamfetol to the mother. 19. The method of claim 15, wherein the infant does not experience agitation due to exposure to the solriamfetol. 20. The method of claim 15, wherein the infant does not experience insomnia due to exposure to the solriamfetol. 21. The method of claim 15, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol. 22. The method of claim 15, wherein the mother is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 23. The method of claim 22, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 24. The method of claim 22, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 25. The method of claim 15, wherein the mother is being treated with solriamfetol to improve wakefulness. 26. The method of claim 15, wherein mother is from about 1 day to about 24 months postpartum. 27. The method of claim 15, wherein mother is from about 10 days to about 52 weeks postpartum. 28. The method of claim 15, wherein the mother is between the ages of 18 and 45 years.