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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  10/26/2018
 
Trade Name:  Xyrem
 
Generic Name or Proper Name (*):  sodium oxybate
 
Indications Studied:  Treatment of cataplexy or excessive daytime sleepiness to pediatric patients 7 years of age and older with narcolepsy
 
Label Changes Summary:  *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.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Jazz Pharmaceuticals
 
Pediatric Exclusivity Granted Date:  10/24/2018
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Depressant
 
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