Drug Interaction:
Redeuced hypnotic effect with phenytoin,carbamazepine Increased drowsiness and incordination with TCAs Increased CNS depresantwith alcohol and other CNS depressants Decreased ziplocone conc. with CYP3A4 inhibitors eg erythromycin, clarithromycin, ketoconazole, itraconazole, ritronavir
Indication:
Short term management of insomnia
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Zopiclone Short-term treatment 16-08-1996
of insomnia
Adverse Reaction:
Metallic taste or bitter after-taste, Irritability, confusion and depressed mood, aggresiveness. Incordination, anterograde, amnesia, Mild increase in LFTs , Drowsiness,lethargy and ataxia,nausea and vomitting. Rarely urticaria and various rashes.
Contra-Indications:
Myastenia gravis, Respiratory failure Severe sleep apnoea syndrome, severe hepatic imparment Pregnancy, lactation, Neonates and children.
Special precautions: Hepatic and renal insufficiency. elderly Psychiatric disorders, history of drug abuse, May impair ability to drive or operate machinery Limit treatment to < 4 weeks to minimise risk of dependence Avoid abrupt discontinuation of therapy
Dosages/ Overdosage Etc:
Date of Approval 1996
Indication
Short term management of insomnia
Dosage-
Adult- 7.5mg at bed time
Elderly - initially 3.75mg at bed time
Interaction with Food:
Absorption may be reduced.
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation Use with caution if required to administered
Manufacturer Details