Zopiclone

Use

Cyclopryrrolone hypnotic. Short-term (i.e. 7-10 consecutive days) insomnia therapy. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient. Adults, 7.5 mg just before retiring for the night. Geriatrics, patients with impaired liver function or chronic respiratory insufficiency: 3.75-7.5 mg at bedtime, depending on acceptability and efficacy.

Contraindications

Myasthenia gravis, sleep apnea syndrome, severe hepatic insufficiency, previous paradoxical reactions to alcohol and/or sedative medications.

Precautions

Not recommended in pregnant or nursing women. Safety-efficacy in patients

Side effects

Bitter taste. Somnolence, confusion, anterograde amnesia or memory impairment, asthenia, euphoria, depression, bad breath, coated tongue.

Interactions

Hepatic enzyme-inhibiting agents (e.g. Cimetidine, crythromycin) and other CNS-depressant drugs may enhance zopiclone's activity.

Patient tips

Warn against concomitant use of alcohol or other CNS-depressant drugs. Caution re drowsiness (NB driving).

Drug Interactions

Patients should be cautioned against the simultaneous ingestion of zopiclone and alcohol or other CNS depressant drugs because of possible additive effects.

Abuse and Dependence

In monkeys, zopiclone was self-administered and caused mild to moderate withdrawal signs. In human subjects only limited data are available to-date regarding the dependence liability of zopiclone. In chronic alcoholics, zopiclone elicited similar effects to those of triazolam. In normal subjects, changes in sleep pattern and rebound anxiety appeared upon discontinuation of the drug.

Addiction-prone individuals, such as drug addicts and alcoholics, should be under careful surveillance when receiving zopiclone because of the predisposition of such patients to habituation and dependence.

Patients with a history of seizures should not be abruptly withdrawn from any CNS depressant drug, including zopiclone.

Amnesia

Anterograde amnesia of varying severity may occur in rare instances following therapeutic doses of zopiclone. Also prior to falling asleep or during interim periods of wakefulness, memory may be impaired.

Geriatrics/Debilitated Patients

In elderly and/or debilitated patients, zopiclone should be initiated at a low dose to reduce the possibility of oversedation, dizziness or impaired coordination. The dose should be increased only if necessary (see Dosage).

Children

Safety and effectiveness in patients under 18 years of age have not been established.

Pregnancy

The safety of zopiclone in pregnant women has not been established. Therefore, the drug is not recommended during pregnancy.

Lactation

Zopiclone is secreted in human milk, and its concentration may reach 50% of the plasma levels. Therefore, the administration of zopiclone to nursing mothers is not recommended.