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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:  03/28/2007
 
Trade Name:  Ambien
 
Generic Name or Proper Name (*):  zolpidem
 
Indications Studied:  Insomnia associated with ADHD
 
Label Changes Summary:  * Safety and effectiveness have not been established in pediatric patients with insomnia associated with ADHD * In an 8-week controlled study in 201 pediatric patients 6-17 years, psychiatric and nervous system disorders comprised > 5% of treatment emergent adverse events, including dizziness (23.5%) headache (12.5%) and hallucinations (7.4%); treatment was discontinued due to an adverse event in 7.4%
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Sanofi Aventis
 
Pediatric Exclusivity Granted Date:  11/20/2006
 
NNPS:  FALSE
 
Therapeutic Category:  Hypnotic
 
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