station day 7 through lactation day 20 post-partum, at 35, 110, and 350 mg/kg/day, which areapproximately 2, 7, and 22 times the MRHD based on mg/m2 body surface area. At ≥ 7 times theMRHD, solriamfetol caused maternal toxicity that included decreased body weight gain,decreased food consumption, and hyperpnea. At these maternally toxic doses, fetal toxicityincluded increased incidence of stillbirth, postnatal pup mortality, and decreased pup weight.
Developmental toxicity in offspring after lactation day 20 included decreased body weight,decreased weight gain, and delayed sexual maturation. Mating and fertility of offspring weredecreased at maternal doses 22 times the MRHD without affecting learning and memory. Theno-adverse-effect level for maternal and developmental toxicity is approximately 2 times the
MRHD based on mg/m2 body surface area.
8.2 Lactation
Risk Summary
There are no data available on the presence of solriamfetol or its metabolites in human milk, theeffects on the breastfed infant, or the effect of this drug on milk production.
Solriamfetol is present in rat milk. When a drug is present in animal milk, it is likely that thedrug will be present in human milk. The developmental and health benefits of breastfeedingshould be considered along with the mother’s clinical need for SUNOSI and any potentialadverse effects on the breastfed child from SUNOSI or from the underlying maternal condition.
Clinical Considerations
Monitor breastfed infants for adverse reactions, such as agitation, insomnia, anorexia andreduced weight gain.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Clinical studies ofSUNOSI in pediatric patients have not been conducted.
8.5 Geriatric Use
Of the total number of patients in the narcolepsy and OSA clinical studies treated with SUNOSI,13% (123/930) were 65 years of age or over.
No clinically meaningful differences in safety or effectiveness were observed between elderlyand younger patients.
Solriamfetol is predominantly eliminated by the kidney. Because elderly patients are more likelyto have decreased renal function, dosing may need to be adjusted based on eGFR in thesepatients. Consideration should be given to the use of lower doses and close monitoring in thispopulation [see Dosage and Administration (2.5)].
8.6 Renal Impairment
Dosage adjustment is not required for patients with mild renal impairment (eGFR60-89 mL/min/1.73 m2). Dosage adjustment is recommended for patients with moderate to
severe renal impairment (eGFR 15-59 mL/min/1.73 m2). SUNOSI is not recommended forpatients with end stage renal disease (eGFR <15 mL/min/1.73 m2) [see Dosage and
Administration (2.5), Warnings and Precautions (5.1, 5.2), Clinical Pharmacology (12.3)].
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
SUNOSI contains solriamfetol. (Controlled substance schedule to be determined after review bythe Drug Enforcement Administration).
9.2 Abuse
SUNOSI has potential for abuse. Abuse is the intentional non-therapeutic use of a drug, evenonce, to achieve a desired psychological or physiological effect. The abuse potential of SUNOSI300 mg, 600 mg, and 1200 mg (two, three, and four times the maximum recommended dose,respectively) was assessed relative to phentermine, 45 mg and 90 mg, (a Schedule IV controlledsubstance) in a human abuse potential study in individuals experienced with the recreati |
