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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Sanofi Aventis
Pediatric Exclusivity Granted Date:
11/20/2006
NNPS:
FALSE'
Therapeutic Category:
Hypnotic
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