Description
Zopiclone (Imovane) is a sedative drug used in the treatment of sleep disorders.
Pharmacology
In research laboratories studying human sleep patterns for 21 days, zopiclone increases the duration of sleep latency and reduce the number of night waking. Stage 1 sleep duration shortened, and time spent in stage 2 sleep increased. In most studies, stage 3 and 4 sleep tended to increase, but there is no change and actual decreases have also been observed. Zopiclone effects on stage 3 and 4 sleep differs from that of the benzodiazepines which suppress slow wave sleep. Clinical significance of this finding is unknown.
Some manifestations of rebound insomnia have been reported in both the sleep laboratory and clinical studies after withdrawal of zopiclone.
At the recommended clinical dose 7.5 mg, peak plasma concentration of 60 ng / mL is achieved within 90 minutes.
Indications and Usage
Short-term management of insomnia characterized by difficulty falling asleep, waking up frequently at night and / or early morning awakening.
Contraindication
Patients with known hypersensitivity to Zopiclone.
Patients with myasthenia gravis; severe respiratory dysfunction; stroke.
Warning
DO NOT EXCEED RECOMMENDED DOSE or take this medicine for more than 4 weeks without checking with your doctor.
Dependence and Withdrawal: Exceeding the recommended dose or taking this medicine for more than the specified can form habits.
Addiction-prone individuals, such as drug addicts and alcoholics, should be under careful surveillance when receiving zopiclone because of the tendency of patients habituation and dependence.
Suicide: Attention must be done if zopiclone is prescribed to depressed patients, including those who latent depression, particularly when suicidal tendencies may be present and protective measures may be needed.
Amnesia: Anterograde amnesia of varying severity can occur in rare cases following a therapeutic dose of zopiclone. Also prior to falling asleep or awake during the interim period, the memory can be disrupted.
Prevention
Elderly or weak patients: In elderly and / or weak patients, zopiclone should be initiated at low doses to reduce the possibility of oversedation, dizziness or disturbance of coordination. The dose should be increased only if necessary.
Use in Children: Safety and effectiveness of zopiclone in children under the age of 18 years is not established.
Pregnancy and Withdrawal: Security zopiclone in pregnant women has not been determined. Therefore, this drug is not recommended during pregnancy. Zopiclone is secreted in human milk, and concentrations can reach 50% of plasma levels. Therefore, the administration of zopiclone to nursing mothers is not recommended.
Cognitive or motor disturbances Performance: Using this medicine alone, with other medicines, or with alcohol may reduce your ability to drive or to perform other tasks that may be dangerous.
Drug Interactions
Patients should be careful of swallowing simultaneous 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 medications you are taking. Inform your doctor other medical conditions, allergies, pregnancy, or breast-feeding.
Adverse reactions
Side Effects, that may go away for treatment, including a bitter taste in the mouth, dizziness, or decreased coordination.
Other side effects include: amnesia or memory disturbances, euphoria, nightmares, anxiety, hostility, decreased libido, abnormal coordination, tremors, muscle spasms, problems speaking, palpitations, dry mouth, nausea, vomiting, diarrhea, constipation, anorexia or increased appetite.
Elderly: Geriatric patients tend to have a higher incidence of palpitations, vomiting, anorexia, sialorrhea, confusion, agitation, anxiety, trembling and sweating than younger patients.
Overdose
Signs and Symptoms
Symptoms of overdose may include excessive sleepiness; slow, shallow breathing; a 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 the signs and clinical symptoms. Respiration, pulse and blood pressure should be monitored and supported by general measures when necessary. Gastric lavage should be done immediately. I.V. liquid that must be provided and maintained adequate air. Keep in mind that some agents may have been ingested.
Dosage
Do not exceed the recommended dose or taking this medicine for more than 4 weeks without checking with your doctor. Exceeding the recommended dose or taking this medicine for more than the specified can form habits.
Follow the directions for using this medicine provided by your doctor.
This drug store at room temperature, in a tightly closed container, away from heat and light.
If you miss a dose of this drug, and you take 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 with other people for whom this drug was not prescribed. Do not use the drug for other health conditions. Keep this medicine out of 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 can be reduced to 3.75 mg.
Elderly or weak patients: An initial dose of 3.75 mg at bedtime is recommended. The dose may be increased to 7.5 mg if initial dose does not offer an adequate therapeutic effect.
Patients with hepatic insufficiency: The recommended dose is 3.75 mg depending on the acceptance and efficacy. Up to 7.5 mg can be used with caution in those cases accordingly.
Use in Children:: Zopiclone is not indicated for patients under the age of 18 years.
Termination: You may have trouble sleeping for 1 to 2 nights after you stop taking this medicine. If continues, contact your doctor.
How Supplied
Each oval, scored blue tablet, contains: Zopiclone 7.5 mg. Also contain sodium.
The information in this monograph is not intended to cover all possible uses, directions, prevention, drug interactions or side effects. This information is general and not intended as specific medical advice. If you have questions about the drugs you are taking or would like more information, check with your doctor, pharmacist, or nurse.
source :http://www.realmentalhealth.com/medications/zopiclone.asp
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