*Safety and effectiveness in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years and older with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study. *Safety and effectiveness in pediatric patients below the age of 7 years have not been established. *The adverse reaction profile in the pediatric clinical trial was similar to that seen in the adult clinical trial program. *In the pediatric clinical trial with Xyrem administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation; suicidal ideation in one patient; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported. *Information on dosing, adverse reactions, clinical trial and PK parameters. *Postmarketing study.
|