Andante - instructions for use, reviews, analogs and forms of release (capsules or tablets 5 mg and 10 mg) drugs for the treatment of insomnia and disturbed sleep in adults, children and pregnancy. Composition and interaction with alcohol

In this article, you can read the instructions for using the drug Andante. Presented are reviews of visitors to the site - consumers of this medication, as well as the opinions of doctors of specialists on the use of the Andante in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of the Andante in the presence of existing structural analogues. Use to treat insomnia and sleep disorders in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Andante - a hypnotic pyrazolo-pyrimidine type, differs in chemical structure from benzodiazepines and other hypnotics. Selectively binds to type 1 benzodiazepine receptors (omega-1).

Significantly reduces the latent time of falling asleep, prolongs the time of sleep (in the first half of the night), does not cause changes in the ratio of different phases of sleep. When used in a dose of 5 mg and 10 mg for 2-4 weeks does not cause pharmacological tolerance. In addition, it has a sedative, slightly expressed anxiolytic, anticonvulsant and central muscle relaxant effect.

Excites benzodiazepine receptors (omega) receptor complexes GABA type A. Interaction with omega receptors leads to the discovery of neuronal ionoform channels for chlorine ions, the development of hyperpolarization and the enhancement of inhibition processes in the central nervous system.

Composition

Zaleplon + auxiliary substances.

Pharmacokinetics

After oral administration quickly and almost completely (about 71%) is absorbed from the digestive tract. As a result of presystemic metabolism, absolute bioavailability is 30%. The plasma concentration is directly proportional to the dose.Taking the drug immediately after ingestion can delay the Cmax time for 2 hours without affecting the absorption of the drug. It is a liposoluble compound. Excreted in breast milk. It is excreted as inactive metabolites, mainly with urine (71%) and feces (17%). Up to 57% of the dose is detected in the urine in the form of 5-oxozaleleton or its metabolites, 9% of the dose in the form of 5-oxo-desethyl-zaleplon or its metabolites, the rest of the dose in the form of less significant metabolites. Among the metabolites that are excreted through the intestine, 5-oxo-oleafol prevails. Quickly excreted from the body.

Pharmacokinetics in elderly patients (including over 75 years) does not differ significantly from that of younger patients.

Indications

• severe forms of sleep disturbance (difficulty in falling asleep), leading to excessive fatigue, hampering daily activity and impairing performance.

Forms of release

Capsules 5 mg and 10 mg (sometimes mistakenly called pills).

Instructions for use and dosing regimen

The duration of therapy should not exceed 2 weeks.

The drug should be taken orally immediately before going to bed, 2 hours after eating or after the patient feels that he can not fall asleep.

The recommended adult dose is 10 mg.The maximum daily dose of 10 mg (the patient must be warned about the dangers of taking a second dose for one night). For elderly patients, the drug is prescribed in a dose of 5 mg (because of greater sensitivity to sleeping pills).

With hepatic insufficiency of mild and moderate severity, the daily dose is 5 mg (because of delayed excretion from the body).

With renal failure of mild to moderate severity, dose adjustment is not required. Data on the safety of the drug in patients with severe renal failure are not available.

The safety of the drug in children under the age of 18 years is not established, so patients of this age group are not given a zaleplon.

Side effect

• abdominal pain;
• nausea, vomiting;
• diarrhea;
• headache;
• weakness;
• increased drowsiness;
• dizziness;
• anterograde amnesia (accompanied by a violation of behavior);
• depression;
• anxiety;
• increased excitability;
• aggressiveness;
• fits of rage;
• nightmarish dreams;
• hallucinations;
• psychosis;
• behavioral disorders;
• development of physical dependence with withdrawal symptoms even when used in therapeutic doses (appearanceinitial symptoms of sleep disorders in a more severe form, as well as mood changes, anxiety, anxiety);
• withdrawal syndrome (headache, myalgia, increased irritability, confusion);
• development of mental dependence leading to drug abuse;
• ataxia;
• tremor;
• increased irritability;
• impaired perception;
• autoaggression;
• hearing loss;
• increased reaction to light, sound and physical stimuli;
• epileptic seizures;
• skin rash;
• itching.

Contraindications

• severe hepatic impairment;
• sleep apnea syndrome;
• severe pulmonary insufficiency;
• severe myasthenia gravis;
• pregnancy;
• lactation period;
• children and adolescents under 18;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

The drug Andante is contraindicated in pregnancy and lactation (breastfeeding).

When prescribing a drug for women of childbearing age, patients should be warned about the need to seek immediate medical attention in the case of conception or when planning a pregnancy.

If Andante is used in the 3rd trimester of pregnancy, or when the drug is used in high doses of the drug during childbirth, the development of hypothermia, muscle hypotension, and moderate respiratory insufficiency as a result of the pharmacological action of the drug may develop in the newborn. In newborns, whose mothers regularly took benzodiazepine or benzodiazepine-like medication in the last weeks of pregnancy, physical dependence and the risk of withdrawal symptoms may develop.

Use in children

Contraindicated in children and adolescents under the age of 18 years.

special instructions

The patient should be warned that the drug is not intended for long-term therapy and the possibility of developing a withdrawal syndrome after the end use of the Andante drug. The course of taking the drug should be short and in no case should not exceed 2 weeks. Extend treatment only after a thorough clinical examination of the patient.

The drug can be prescribed to elderly patients (including over 75 years old).

Disturbance of sleep can be the result of diseases (including mental diseases).If, after a short-term use of the Andante drug, sleep does not return to normal or if a sleep disturbance progresses, the clinical situation should be reassessed.

If the patient wakes up soon after midnight (due to the short half-life of Zaleplon), another drug with a longer half-life may be required. It should be warned patients about the need to use no more than 1 capsule per night.

The use of benzodiazepines and benzodiazepine-like short-acting drugs for several weeks can be accompanied by a decrease in the hypnotic effect.

The use of benzodiazepines and benzodiazepine-like drugs may lead to the development of physical and mental dependence, the likelihood of which increases when used in high doses, with prolonged therapy, chronic alcoholism and drug dependence in a patient's history.

With the resulting physical dependence, abrupt withdrawal of the drug leads to the development of withdrawal symptoms: headache, myalgia, severe anxiety, increased tension and irritability, psychomotor agitation, confusion.In severe cases, autoaggression, depersonalization, hearing loss, paresthesia in the extremities, an increased response to light, sound and physical stimuli, hallucinations and epileptic seizures are possible.

After discontinuation of the use of benzodiazepines and benzodiazepine-like drugs, the appearance of transient and more pronounced symptoms of insomnia (withdrawal syndrome) than at the beginning of treatment is possible. It is possible to develop other related phenomena (mood changes, anxiety, sleep disturbances or anxiety).

Benzodiazepines and benzodiazepine-like drugs can cause the development of anterograde amnesia and impaired psychomotor functions. To avoid the development of these symptoms, the drug should be taken only if the patient has the possibility of continuous sleep, at least for 4 hours after taking the drug.

Treatment Andante should be discontinued in case of increased excitability, irritability, aggressiveness, impaired perception, nightmarish dreams, hallucinations, psychotic disorders and especially behavioral disorders. Children and elderly patients are most likely to develop such symptoms.

The drug is not intended to treat depression and / or anxiety, can be used to implement suicidal intentions, often accompanying depressive disorders. Patients with depression, the drug can be administered in a minimal dose to avoid a conscious overdose.

It is not recommended to prescribe the drug to patients with severe hepatic insufficiency because of the danger of encephalopathy.

When lactose intolerance, it should be noted that the capsule containing 5 mg Zaleplon contains 67 mg lactose.

Impact on the ability to drive vehicles and manage mechanisms

During the period of drug use, it is necessary to refrain from driving motor vehicles and taking classes that require an increased concentration of attention and speed of psychomotor reactions. sedative effect, amnesia, decreased concentration of attention and muscle strength adversely affect the ability for such activities.

Drug Interactions

Simultaneous reception of ethanol (alcohol) or ethanol-containing medicines increases the sedative effect of Andante.

Simultaneous use of antipsychotics (neuroleptics), other hypnotics, anxiolytic, sedative, antidepressant, antiepileptic, antihistamines, anesthetics, opioid analgesics leads to an increase in the sedative effect of zaleplon.

With simultaneous use with opioid analgesics, a manifestation of the euphoric effect of the latter, leading to the development of drug dependence, is possible.

With the simultaneous use of cimetidine (inhibitor aldehyde oxidase and CYP3A4) increases the concentration of zaleplon in plasma by 85%.

At the same time, selective inhibitors of CYP3A4 (ketoconazole, erythromycin) increase the concentration of zaleplon in the plasma and increase its sedative effect (sometimes using Andante dose correction).

With the simultaneous use of inducers CYP3A4 (rifampicin, carbamazepine, Phenobarbital derivatives) can reduce the efficacy of zaleplon by 25%.

With the simultaneous use of zaleplon does not affect the pharmacodynamics and pharmacokinetics of Digoxin and Warfarin (dose adjustment of these drugs is not required).

Interactions Ibuprofen with zaleplon is not revealed.

Analogues of the Andante drug

Structural analogs for the active substance:

• Zaleplon.

Analogues on the pharmacological group (hypnotics):

• Apo Flurazepam;
• Berlidorm 5;
• Bromizoval;
• Valocordin Doxylamine;
• Heminearrin;
• Hypnogen;
• Diphenhydramine hydrochloride;
• Donormil;
• Dormikum;
• Zaleplon;
• Zolpidem;
• Zolsana;
• Zopiclone;
• Iwadal;
• Imovan;
• Melaxen;
• Melatonin;
• Nitrazadone;
• Nitrazepam;
• Nitram;
• Nitrust;
• Nitrosan;
• Onyria;
• Piklodorm;
• Radedorm 5;
• Reladorm;
• Relaxon;
• The Raslip;
• Rohypnol;
• Sanvall;
• Signopam;
• Snovitel;
• Somnol;
• Thorson;
• Phenobarbital;
• Flormidal;
• Circadian;
• Estazolam;
• Eunotin.

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