# US 12,005,036 B1 · Methods of administering solriamfetol to lactating women > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,036 B1 - Document ID: US12005036B1 - Status: Granted - Kind: B1 - Application number: 18/491,291 - Filed: 2023-10-20 - Published: 2024-07-04 - Granted: 2024-06-11 - Earliest claimed: 2022-12-30 - Assignees: Axsome Malta Ltd. - Applicants: Axsome Malta Ltd. - Inventors: Herriot Tabuteau - Web page: https://patentgrep.com/patent/US12005036B1 ## CPC - A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## 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. ## Claims ### Claim 1 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) The method of claim 1, wherein the infant does not experience agitation due to exposure to the solriamfetol. ### Claim 4 (depends on 1) The method of claim 1, wherein the infant does not experience insomnia due to exposure to the solriamfetol. ### Claim 5 (depends on 1) The method of claim 1, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) The method of claim 1, wherein the elimination half-life of the solriamfetol excreted in the breast milk is approximately 5 hours. ### Claim 8 (depends on 1) The method of claim 1, wherein breast milk produced by the nursing mother during the at least about 3.5 hours of the mother receiving an oral once-daily dose of solriamfetol is expressed and discarded. ### Claim 9 (depends on 1) 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. ### Claim 10 (depends on 9) The method of claim 9, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. ### Claim 11 (depends on 9) The method of claim 9, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. ### Claim 12 (depends on 1) The method of claim 1, wherein the mother is being treated with solriamfetol to improve wakefulness. ### Claim 13 (depends on 1) The method of claim 1, wherein the lactating mother is from about 1 day to about 24 months postpartum. ### Claim 14 (depends on 1) The method of claim 1, wherein the lactating mother is from about 10 days to about 52 weeks postpartum. ### Claim 15 (depends on 1) The method of claim 1, wherein the lactating mother is between the ages of 18 and 45 years. ### Claim 16 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. ### Claim 17 (depends on 16) The method of claim 16, 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. ### Claim 18 (depends on 16) The method of claim 16, wherein the infant does not experience agitation due to exposure to the solriamfetol. ### Claim 19 (depends on 16) The method of claim 16, wherein the infant does not experience insomnia due to exposure to the solriamfetol. ### Claim 20 (depends on 16) The method of claim 16, wherein the infant does not experience anorexia and/or reduced weight gain due to exposure to the solriamfetol. ### Claim 21 (depends on 16) The method of claim 16, wherein the solriamfetol is excreted in the breast milk with a milk to plasma AUC ratio of approximately 2:1. ### Claim 22 (depends on 16) The method of claim 16, wherein the elimination half-life of the solriamfetol excreted in the breast milk is approximately 5 hours. ### Claim 23 (depends on 16) The method of claim 16, wherein breast milk produced by the nursing mother during the at least about 3.5 hours of the mother receiving an oral once-daily dose of solriamfetol is expressed and discarded. ### Claim 24 (depends on 16) The method of claim 16, 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. ### Claim 25 (depends on 24) The method of claim 24, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. ### Claim 26 (depends on 24) The method of claim 24, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. ### Claim 27 (depends on 1) The method of claim 1, wherein the mother is being treated with solriamfetol to improve wakefulness. ### Claim 28 (depends on 1) The method of claim 1, wherein the lactating mother is from about 1 day to about 24 months postpartum. ### Claim 29 (depends on 1) The method of claim 1, wherein the lactating mother is from about 10 days to about 52 weeks postpartum. ### Claim 30 (depends on 1) The method of claim 1, wherein the lactating mother is between the ages of 18 and 45 years.