Short-term treatment of insomnia in adults - temporary, short-term or chronic (including difficulty in falling asleep, short sleep, early morning waking up).
Composition:
1 tabl powl. contains 7.5 mg of zopiclone.
Action:
A hypnotic drug from the group of cyclopyrrolone derivatives. It works soporific, calming, anxiolytic, anticonvulsant and reduces muscle tone. The action of zopiclone is associated with its specific agonist effect on the gabergic receptor complex, leading to the opening of the chloride channel. Zopiklon facilitates falling asleep and reduces the number of awakenings at night, extends sleep time and improves the quality of sleep and well-being after waking up. After oral administration, zopiclone is rapidly absorbed from the gastrointestinal tract, reaching a maximum blood concentration after 1.5-2 hours. Plasma proteins are bound in 45%. It is metabolized in the liver, partly to active metabolites. It is mainly excreted in urine (80%) and faeces (approximately 16%). T0,5 is about 5 hours.
Contraindications:
Hypersensitivity to zopiclone or other ingredients of the preparation. Myasthenia gravis. Respiratory failure. Severe form of sleep apnea syndrome. Severe hepatic failure. The efficacy and safety of patients under 18 years have not been established.
Precautions:
Do not use zopiclone to treat depression. Use with caution in patients who abuse alcohol and drugs (increased risk of addiction). In the event of psychological and paradoxical reactions (anxiety, agitation, irritability, aggressiveness, delusions, anger, nightmares, hallucinations, inadequate behavior) and somnambulism during the use of the drug, it is recommended to discontinue the preparation. To reduce the risk of subsequent follow-up, the patient should be provided with uninterrupted sleep all night long. The preparation contains lactose and should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Zopiclone is not recommended during pregnancy. The use of the drug in the third trimester of pregnancy or during delivery may cause hypothermia, hypotonia and respiratory depression in the newborn. Zopiclone is excreted in breast milk - do not use the drug during breastfeeding.
Side effects:
Common: bitter taste in the mouth, drowsiness, dry mouth. Uncommon: nightmares, agitation, pain and dizziness, nausea, tiredness. Rare: irritability, libido disorders, confusion, hallucinations, aggression, amnesia, pruritus, rash, collapse (mostly in elderly patients). Very rare: angioneurotic edema, anaphylactic reactions, slight to moderate increases in serum transaminases and / or alkaline phosphatase. In addition: anxiety, delusions, anger, inadequate behavior, somnambulism, ataxia, double vision, indigestion, muscle weakness. Long-term use of the drug (more than a few weeks) may lead to the development of tolerance to the drug and the occurrence of addiction. Abrupt discontinuation in such cases may lead to withdrawal symptoms (insomnia, head and muscle pain, anxiety, tension, tremor, agitation, confusion, irritability, sweating, palpitations, tachycardia, severe cases: derealization, depersonalization, and numbness). tingling of the limbs, hypersensitivity to acoustic stimuli, touch and light, hallucinations and fits). After discontinuation of zopiclone, temporary insomnia "from rebound" may occur.
Dosage:
Orally. Adults: 7.5 mg, immediately before bedtime. In elderly patients with renal or hepatic impairment and in patients with chronic respiratory failure, treatment should start at a dose of 3.75 mg daily. Treatment should last as short as possible, no longer than 4 weeks, including the period of gradual dose reduction. In exceptional situations, a longer period of administration may be recommended after careful assessment of the patient's condition. Duration of treatment: transient insomnia - 2-5 days; insomnia short-term - 2-3 weeks
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