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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:  10/10/2012
 
Trade Name:  Lunesta
 
Generic Name or Proper Name (*):  eszopiclone
 
Indications Studied:  Attention-Deficit Hyperactivity Disorder associated insomnia
 
Label Changes Summary:  *Safety and effectiveness have not been established in pediatric patients*Lunesta failed to demonstrate efficacy in a 12-week controlled study of 483 pediatric patients 6-17 years with insomnia associated with ADHD *Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse reactions observed with Lunesta versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%) * Information on dose, adverse reactions clinical trial and juvenile animal studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Sunovion Pharmaceuticals
 
Pediatric Exclusivity Granted Date:  06/29/2012
 
NNPS:  False
 
Therapeutic Category:  Hypnotic
 
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