Index of drugs

Treatment of patients with insomnia who have difficulty falling asleep. The drug is recommended only in the case of severe disorders, preventing a normal lifestyle or causing serious discomfort for the patient.

One capsule contains 10 mg of zaleplon. The capsules contain lactose.

A hypnotic drug from the pyrazolopyrimidine group, structurally different from benzodiazepines and other hypnotics. It binds selectively to the benzodiazepine type I receptor. Zaleplon applied at a dose of 10 mg in the study of patients in the power of age treated with outpatients reduced sleep latency up to 4 weeks. After oral administration, zaleplon is absorbed quickly and almost completely (at least 71%). C_max reaches after about 1 hour. Bioavailability is about 30%. It binds about 65% of plasma proteins. It is metabolized primarily in the liver. Zaleplon is excreted in the form of inactive metabolites, mainly in urine (71%) and faeces (17%)._0,5 is about 1 hour.

Hypersensitivity to zaleplon or other component of the preparation. Severe liver dysfunction. Severe kidney problems. Sleep apnea syndrome. Myasthenia gravis. Severe respiratory failure. Children (under the age of 18).

Benzodiazepines and drugs similar in their effects should not be used in monotherapy of depression or anxiety associated with depression (suicidal ideation may increase in such patients). Due to the increased risk of intentional overdose in people with depression, the amount of prescribed drug should be limited to the necessary minimum. It is recommended to discontinue the use of zaleplon in patients who have experienced half-sleep. Other complex behaviors in the state of incomplete awareness have also been described (eg preparation and consumption of meals, telephone conversations, sexual intercourse). Do not attempt treatment again in patients who have had angioneurotic edema after zaleplon. If the patient wakes up prematurely, alternative treatment should be considered. If repeatedly used for several weeks, the hypnotic effect may be reduced. The use of benzodiazepines and drugs with similar mechanisms of action as benzodiazepines may lead to the formation of physical and mental dependence. The risk of developing addiction increases with the dose and duration of use, and is greater in patients who have a history of alcohol and drug abuse. If physical dependence develops, the withdrawal is accompanied by withdrawal symptoms. These may include headaches, muscle aches, severe anxiety, tension, anxiety, confusion and irritability. In severe cases, the following symptoms may occur: feelings of unreality, depersonalization, hypersensitivity to sounds, numbness and tingling of the extremities, hypersensitivity to light, noise and touch, hallucinations or epileptic seizures. There have been post-marketing reports of dependence caused by zaleplon, mainly given in combination with other psychotropic drugs. After discontinuation of the preparation, a transient symptom syndrome may occur in severe form, which caused the initiation of treatment with benzodiazepine or its derivatives. There may be other reactions including changes in mood, anxiety or sleep disturbances and anxiety. After taking benzodiazepines or drugs with benzodiazepine-like effects, psychic and paradoxical reactions may occur, especially in patients Elderly. If these symptoms occur, treatment should be discontinued. Benzodiazepines and drugs similar to those used should be used with extreme caution in patients with a history of alcohol or drug addiction. Use with caution in patients with mild to moderate hepatic impairment. Special care should be taken in patients with chronic respiratory failure. Benzodiazepines and benzodiazepine-like drugs are not recommended for the treatment of basic psychosis.The preparation contains lactose monohydrate, therefore patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug.

The use of the preparation during pregnancy is not recommended. The use of zaleplon in high doses at the end of pregnancy or during delivery may cause newborn hypothermia, hypotension and moderate respiratory depression. In infants whose mothers in advanced pregnancy have taken long-term benzodiazepines and drugs with similar mechanisms of action, physical dependence may develop and there is a risk of withdrawal symptoms during the postnatal period. Because zaleplon is excreted in breast milk, the preparation should not be used by women who are breastfeeding.

Common: amnesia, paresthesia, drowsiness, dysmenorrhea. Uncommon: disorder or lack of coordination of movements, dizziness, reduced concentration, olfactory hallucinations, speech disorders (dysarthria, speech blurred), hypoaesthesia, visual disturbances, double vision, hyperaesthesia, nausea, photosensitivity, anorexia, asthenia, malaise , depersonalization, hallucinations, depression, confusion, apathy. Very rare: anaphylactic / anaphylactoid reactions. Not known: angioneurotic edema, hepatotoxicity (mainly reported as elevated aminotransferase activity), somnambulism. During the use of the drug in the recommended therapeutic doses, follow-up amnesia may occur and the risk of its occurrence increases after higher doses. When using benzodiazepines or medicines similar to them, the following symptoms may occur: anxiety, agitation, irritability, reduced inhibition, aggressiveness, lack of logical thinking, delusions, anger, nightmares, depersonalization, hallucinations, psychosis, inadequate behavior, extraversion remaining in non-compliance with the nature of the person and other undesirable behavioral reactions. The occurrence of the symptoms described is more likely to occur in the elderly. The use of the preparation may lead to physical dependence (discontinuation of treatment may cause symptoms of abstinence syndrome or rebound effects) and mental dependence. Cases of abuse of benzodiazepines and drugs with similar effects have been reported. When using benzodiazepines or benzodiazepine-like drugs, the depressive disorders existing in the patient may become apparent.

Orally. Adults: the recommended dose is 10 mg. Treatment should last as short as possible, maximum 2 weeks. The drug should be taken immediately before going to bed or after going to bed if the patient has difficulty falling asleep. Do not use a daily dose of more than 10 mg. Do not give your second dose the same night. In patients with mild or moderate hepatic impairment and in the elderly, a 5 mg dose is recommended. Do not use the medicine in time or immediately after a meal.