Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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 patientsLunesta 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
BPCA(B) and PREA(P):
B,P
Sponsor:
Sunovion Pharmaceuticals
Pediatric Exclusivity Granted Date:
06/29/2012
NNPS:
FALSE'
Therapeutic Category:
Hypnotic
-
-