Zopiclone Full Prescribing Information

Brand Name: Imovane
Generic Name: Zopiclone

Zopiclone (Imovane) is a hypnotic agent used to treat insomnia. Uses, dosage, side effects of Imovane.

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Description

This medicine is a hypnotic agent used to treat sleep disorders.

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Pharmacology

The pharmacological profile of zopiclone is similar to that of the benzodiazepines.

In sleep laboratory studies of 1 to 21-day duration in man, zopiclone reduced sleep latency, increased the duration of sleep and decreased the number of nocturnal awakenings. Zopiclone delayed the onset of REM sleep but did not reduce consistently the total duration of REM periods. The duration of stage 1 sleep was shortened, and the time spent in stage 2 sleep increased. In most studies, stage 3 and 4 sleep tended to be increased, but no change and actual decreases have also been observed. The effect of zopiclone on stage 3 and 4 sleep differs from that of the benzodiazepines which suppress slow wave sleep. The clinical significance of this finding is not known.

Some manifestations of rebound insomnia have been reported both in sleep laboratory and clinical studies following the withdrawal of zopiclone.

At the clinically recommended dose of 7.5 mg, peak plasma concentration of 60 ng/mL is achieved within 90 minutes.

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Indications and Usage

The short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakening.

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Contraindications

Patients with known hypersensitivity to Zopiclone.

Patients with myasthenia gravis; severe impairment of respiratory function; stroke.

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Warnings

DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than 4 weeks without checking with your doctor.

Dependency and Withdrawl: Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming.

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.

Suicide: Caution should be exercised if zopiclone is prescribed to depressed patients, including those with latent depression, particularly when suicidal tendencies may be present and protective measures may be required.

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.

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Precautions

Elderly or 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

Usage in Children:: The safety and effectiveness of zopiclone in children below the age of 18 have not been established.

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

Interference with Cognitive or Motor Performance: Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

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Drug Interactions

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

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

Side Effects, that may go away during treatment, include bitter taste in mouth, drowsiness, or decreased coordination.

Other sides effects include: amnesia or memory impairment, euphoria, nightmares, agitation, hostility, decreased libido, coordination abnormality, tremor, muscle spasms, speech disorder, heart palpitations, dry mouth, nausea, vomiting, diarrhea, constipation, anorexia or increased appetite.

Elderly: Geriatric patients tended to have a higher incidence of palpitations, vomiting, anorexia, sialorrhea, confusion, agitation, anxiety, tremor and sweating than younger patients.

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Overdose

Signs and Symptoms

Symptoms of overdose may include excessive drowsiness; slow, shallow breathing; sudden onset of sweating; pale skin; blurred vision; and loss of consciousness.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

Treatment should be supportive and in response to clinical signs and symptoms. Respiration, pulse and blood pressure should be monitored and supported by general measures when necessary. Immediate gastric lavage should be performed. I.V. fluid should be administered and an adequate airway maintained. It should be kept in mind that multiple agents may have been ingested.

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Dosage

Do not exceed the recommended dose or take this medicine for longer than 4 weeks without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming.

• Follow the directions for using this medicine provided by your doctor.
• Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
• If you miss a dose of this medicine, and you are taking 1 dose daily at bedtime, skip the missed dose. Do NOT take the missed dose in the morning or take 2 doses at once.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

Adults: The usual dose is 7.5 mg at bedtime. This dose should not be exceeded. Depending on clinical response and tolerance, the dose may be lowered to 3.75 mg.

Elderly or debilitated patients: An initial dose of 3.75 mg at bedtime is recommended. The dose may be increased to 7.5 mg if the starting dose does not offer adequate therapeutic effect.

Patients with hepatic insufficiency: The recommended dose is 3.75 mg depending on acceptability and efficacy. Up to 7.5 mg may be used with caution in appropriate cases.

Usage in Children:: Zopiclone is not indicated for patients under 18 years of age.

Discontinuation: You may experience trouble sleeping for 1 to 2 nights after you stop taking this medicine. If it continues, contact your doctor.

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How Supplied

Each oval, scored blue tablet, contains: Zopiclone 7.5 mg. Also contains sodium.

Detailed Info on Signs, Symptoms, Causes, Treatments of Anxiety Disorders

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.

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