Label Changes for:
Rozerem (ramelteon) Tablets
November 2010
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010
PRECAUTION
Drug Interactions
- Donepezil increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with donepezil.
- Doxepin increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with doxepin.
