ADMINISTRATION ROUTES:
PO, NG
ALTERNATIVE NAMES:
Imovane, Arrow-Zopiclone, Zopiclone Actavis
ICU INDICATIONS:
- Insomnia
PRESENTATION AND ADMINISTRATION:
PO, NG
Arrow-Zopiclone 3.75 mg and 7.5 mg tablet, Zopiclone Actavis 3.75 mg and 7.5 mg tablet, Imovane 7.5 mg tablet.
Tablets can be crushed for NG administration.
DOSAGE:
PO / NG:
3.75 - 7.5 mg nocte
DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:
Dose as in normal renal function
DOSAGE IN PAEDIATRICS:
PO / NG:
Not recommended for use in children
CLINICAL PHARMACOLOGY:
Zopiclone is a short-acting hypnotic with a pharmacological role similar to that of the benzodiazepenes. It has hypnotic, sedative, anxiolytic, anti-convulsant & musclerelaxant properties. It has negligible residual effects the following morning without rebound insomnia on cessation of treatment.
It is rapidly & well absorbed after oral administration with an elimination half-life of 5 hours, prolonged to 7 hours in the elderly.
It is not removed effectively by haemodialysis due to a large volume of distribution.
CONTRAINDICATIONS:
- Hypersensitivity to Zopiclone
- Myasthenia gravis
- Severe sleep apnoea syndrome
- Severe hepatic insufficiency (can precipitate encephalopathy)
- Respiratory failure
WARNINGS:
Risk of dependence if treatment duration is longer than 4 weeks; this is increased in patients with a history of drug abuse, alcoholism or personality disorders.
Risk of rebound & withdrawal after abrupt discontinuation after prolonged treatment. Gradual dose decrement is recommended, especially so in patients with a history of seizures.
Anterograde amnesia may occur especially in the elderly or with disruption of sleep. This effect is dose-related. The risk of confusion is also higher in the elderly & in patients with cerebral impairment.
Angioedema and signs of anaphylaxis have been reported (rarely) with administration, including after the initial dose. Patients developing angioedema should discontinue therapy and should not be rechallenged.
PRECAUTIONS:
General:
Additive effect with concomitant use of other central depressant drugs.
Laboratory Tests:
No tests are required in addition to routine ICU blood tests
Drug/Laboratory Test Interactions:
None known
IMPORTANT DRUG INTERACTIONS FOR THE ICU:
Activity may be enhanced when co-administered with drugs that inhibit hepatic enzymes (particularly cytochrome P450) such as cimetidine or erythromycin.
ADVERSE REACTIONS:
Nervous system:
Drowsiness, uncoordination, headaches, fatigue, delirium
Cardiovascular:
Arrhythmias (especially in elderly patients)
Digestive:
Dry mouth, heartburn, constipation, diarrhoea, nausea, vomiting
Skin:
Urticaria, tingling, rash