Sonata Adamed - Instructions For Use, Reviews, The Price Of Capsules, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sonata Adamed

Sonata Adamed: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sonata Adamed

ATX code: N05CF03

Active ingredient: zaleplon (Zaleplon)

Manufacturer: Adamed Pharma, S. A. (Adamed Pharma, SA) (Poland); Pabianice Pharmaceutical Plant Polfa, JSC (Pharmaceutical Works Polfa SA in Pabianice) (Poland)

Description and photo update: 2020-09-01

Prices in pharmacies: from 417 rubles.

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Sonata Adamed is a hypnotic drug.

Release form and composition

The drug is produced in the form of capsules: hard, gelatinous, size No. 3, with a blue cap and a pink body; capsules are filled with almost white to white powder (10 pcs. in blisters made of polyvinyl chloride film and aluminum foil; in a cardboard box 1 or 2 blisters and instructions for the use of Sonata Adamed).

Composition for 1 capsule:

• active substance: zaleplon - 10 mg;
• auxiliary components: MCC (microcrystalline cellulose) - 72 mg; lactose monohydrate (milk sugar) - 71.01 mg; sodium lauryl sulfate - 6.8 mg; colloidal silicon dioxide - 0.85 mg; KMC (sodium carboxymethyl starch) - 8.5 mg; magnesium stearate - 0.85 mg;
• capsule body: black iron oxide dye - 0.03%; dye iron oxide red - 0.16%; titanium dioxide - 2.333 3%; dye azorubin - 0.042 9%; gelatin - up to 100%;
• capsule cap: indigo carmine dye - 0.047 1%; titanium dioxide - 1%; gelatin - up to 100%.

Pharmacological properties

Pharmacodynamics

The active ingredient of Sonata Adamed is zaleplon, which belongs to the pyrazolopyrimidine class. In terms of chemical structure, it differs from other hypnotics, it is a non-benzodiazepine derivative.

Zaleplon binds selectively to type I benzodiazepine receptors, a subtype of omega-1. It significantly reduces the latency of falling asleep, prolongs the period of sleep in the first half of the night, and does not cause changes in the ratio of different sleep phases. Therapy with the drug at a dose of 10 mg / day, provided the duration of the course is from 2 to 4 weeks, does not entail pharmacological tolerance. Additionally, Sonata Adamed has a mild anxiolytic, sedative, anticonvulsive and central muscle relaxant effect.

The mechanism of action is based on the excitation of benzodiazepine receptors of the omega-1 subtype of GABA (gamma-aminobutyric acid) type A receptor complexes, which contributes to the opening of neuronal monomorphic channels for chlorine ions with the development of hyperpolarization and increased inhibition processes in the central nervous system (central nervous system).

Pharmacokinetics

The main pharmacokinetic characteristics of zaleplon:

• absorption: after oral administration, zaleplon is absorbed in the digestive tract quickly and in large volumes (up to 71%). C _max (maximum concentration) of the substance in the blood is reached after an hour. The absolute bioavailability as a result of presystemic metabolism is about 30%. The content of the substance in the plasma changes in direct proportion to the dose taken. Taking the drug immediately after a meal can delay the time to reach C _{max for} up to 2 hours, but this does not affect the degree of its absorption;
• distribution to tissues and organs: zaleplon is a fat-soluble compound. It binds to plasma proteins at a level of ~ 60%, as a result of which the likelihood of the interaction of Sonata Adamed with other drugs is very small. The substance passes into breast milk. V _d (volume of distribution) after intravenous administration varies from 1.1 to 1.7 l / kg;
• metabolic processes: Zaleplon is primarily metabolized with the participation of aldehyde oxidase to form the 5-oxosaleplon metabolite. Under the action of the cytochrome CYP3A4 isoenzyme, another metabolite of zaleplon, desethylzaleplon, is formed, which in turn, with the participation of aldehyde oxidase, is biotransformed into 5-oxo-desethylzaleplon. Thereafter, all oxidation products are conjugated with glucuronic acid. Zaleplon metabolites are pharmacologically inactive. Taking the substance in daily doses of up to 30 mg does not lead to cumulation. T _1/2 (half-life) is ~ 1 hour;
• excretion: zaleplon is excreted in the form of inactive metabolites, mainly by the kidneys - up to 71% and through the intestines - 17%. In urine from the dose taken is determined: in the form of 5-oxosaleplon, as well as its metabolites - up to 57%; in the form of 5-oxo-deethylzaleplon and its metabolites - up to 9%; the remainder of the dose is excreted as less significant metabolites. Among the metabolites found in feces, 5-oxosaleplone also predominates; it is rapidly excreted from the body.

Pharmacokinetics in special groups:

• elderly patients, including over 75 years old: the effect of Sonata Adamed does not differ significantly from that of younger patients;
• renal failure: the effect of the drug does not differ significantly from that in patients with normal renal function, although the concentration of inactive metabolites in renal impairment is higher.

Indications for use

Sonata Adamed is recommended for the short-term treatment of severe sleep disorders and difficulty falling asleep, which result in excessive fatigue, difficulties with daily activities and reduced performance.

Contraindications

Absolute:

• severe renal failure;
• severe hepatic insufficiency, moderate hepatic dysfunction (for this dosage form);
• sleep apnea syndrome;
• severe pulmonary insufficiency;
• myasthenia gravis;
• acute respiratory failure;
• pregnancy and lactation period;
• hypolactasia, lactase deficiency, glucose-galactose malabsorption;
• children and adolescents up to 18 years old;
• advanced age (for this dosage form);
• hypersensitivity to zaleplon or any of the auxiliary components of the hypnotic.

Relative contraindications for which Sonata Adamed capsules should be taken with caution are mild to moderate renal impairment, mild hepatic impairment, depressive disorders, and alcohol / drug dependence (including a history).

Sonata Adamed, instructions for use: method and dosage

Sonata Adamed capsules are intended for oral administration. It is advisable to take them before going to bed, 2 hours after dinner, or immediately after the patient feels that he is not able to fall asleep on his own.

The daily recommended, it is the maximum daily, the dose for adults is 10 mg.

Patients should be warned that it is unacceptable to take the drug again overnight.

The duration of the therapeutic course should not exceed two weeks.

Side effects

Most often, patients taking Sonata Adamed complain of drowsiness, memory loss, sensory disorders, characterized by spontaneously arising sensations of tingling, burning and creeping on the skin, and women may experience dysmenorrhea.

Systematization of unwanted side effects by frequency is given by systemic organ classes in accordance with the international dictionary of classification of adverse reactions MedDRA [the following gradation was used: very often (≥ 0.1); often (from ≥ 0.01 to <0.1); infrequently (from ≥ 0.001 to <0.01); rarely (from ≥ 0.000 1 to <0.001); extremely rare (<0.000 1); frequency is unknown (based on available observations, it is impossible to estimate the frequency of occurrence)]:

• immune system: extremely rare - anaphylactic or anaphylactoid reactions;
• metabolism and nutrition: infrequently - decreased appetite;
• psyche: infrequently - depersonalization, hallucinations, depression, confusion, apathy; frequency unknown - somnambulism;
• CNS: often - amnesia, sensitivity disorders, drowsiness; infrequently - ataxia / impaired coordination, dizziness, impaired ability to concentrate, parosmia, speech impairment (slurred speech, dysarthria), hypesthesia;
• organ of vision: infrequently - blurred vision, diplopia;
• organ of hearing and labyrinthine disorders: infrequently - hyperacusis;
• gastrointestinal tract: infrequently - nausea;
• hepatobiliary system: frequency unknown - hepatotoxicity (increased activity of liver enzymes);
• skin and subcutaneous fat: infrequently - photosensitivity reaction; frequency unknown - angioedema;
• reproductive system and mammary gland: often - dysmenorrhea;
• systemic disorders: infrequently - asthenia, malaise.

In each group, adverse side effects are presented in decreasing order of severity.

Overdose

Intoxication with zaleplon (as well as benzodiazepines and other benzodiazepine-like substances) does not cause conditions that threaten the patient's health and life, provided that sleeping pills are not taken in combination with other drugs that depress the central nervous system, including alcohol. Therefore, if an overdose is suspected, one should not forget about the high likelihood of combined poisoning.

A sign of an overdose of zaleplon is the symptomatology of CNS depression, expressed by suppression of consciousness from a state of drowsiness to coma. In case of mild poisoning, this can be confusion, drowsiness and lethargy, and in more severe cases - muscle hypotension, ataxia, respiratory depression, decreased blood pressure, urine staining blue-green (a sign of chromaturia), less often - coma, in extremely rare fatal cases.

The antagonist of zaleplon is the detoxifying drug flumazenil, is its antidote and is used in case of an overdose of Sonata Adamed.

Recommended measures in the first hour after an overdose of zaleplon: induction of vomiting, gastric lavage, intake of absorbents (for example, activated carbon). It is also necessary to provide monitoring of cardiac and respiratory activity, which should be carried out in the intensive care unit.

special instructions

Before the start of therapy, the patient is warned about the short duration of the course and the possible development of a withdrawal syndrome upon completion of treatment with Sonata Adamed. The duration of taking the drug should be as short as possible, under no circumstances exceeding two weeks. The attending physician, after a thorough examination of the patient, prolongs the course if there is evidence of clinical need. Since sleep disturbance can also be the result of a physical / mental illness, if short-term use of Sonata Adamed does not normalize sleep, or sleep disturbances progress, the diagnosis must be verified.

Patients who wake up shortly after midnight due to a short T _{1/2 of the} zaleplon may need another sleeping pill with a high T _1/2. It is strictly forbidden to use more than one capsule per night.

Short-acting benzodiazepines and benzodiazepine-like drugs used for several weeks in a row can cause a decrease in hypnotic effects. Taking them can lead to the development of physical / mental dependence associated with the use of high doses of the drug, long-term therapy, alcohol and drug dependence syndrome.

Abrupt withdrawal of Sonata Adamed is contraindicated in patients with developed physical dependence, since it leads to the development of withdrawal syndrome. It is characterized by the following symptoms: headache, muscle pain, a pronounced state of anxiety, increased tension and irritability, psychomotor agitation, confusion. In severe cases, hearing loss, autoaggression, depersonalization, paresthesia of the extremities, hypertrophied reaction to sound / light / physical stimuli, hallucinations, and epileptic seizures may develop.

Upon completion of the course of benzodiazepines and benzodiazepine-like drugs, a relapse or withdrawal syndrome is likely to develop, characterized by transient and more pronounced symptoms of insomnia than at the beginning of treatment. This does not exclude the development of other concomitant reactions, for example, anxiety, mood lability, sleep disturbance or anxiety.

Anterograde amnesia and impaired psychomotor functions can be a consequence of taking benzodiazepines and benzodiazepine-like drugs. To avoid the development of this symptomatology, Sonata Adamed should be taken only if the patient is able to sleep continuously after taking the capsule for at least 4 hours in a row.

During therapy with sedatives and hypnotics, patients may experience combinations of actions such as "eating in sleep", "driving in a dream" or "sex in a dream." These actions were observed when patients who were not quite awake after taking sedatives / sleeping pills performed them, but, as a rule, did not remember what was happening to them. With the development of such conditions, it is recommended to discontinue therapy.

Reception of zaleplon is stopped when irritability, excitability, aggressiveness increase, in case of extraversion, hallucinations, nightmares, psychotic disorders (especially behavioral disorders), as well as disturbances in perception and thinking. Elderly patients are more likely to develop such symptoms.

Zaleplon is prescribed with caution if there is a history of allergic responses to sedation / hypnotics. In extremely rare episodes, Sonata Adamed can cause anaphylactic or anaphylactoid reactions that require immediate medical attention. Re-taking the drug is contraindicated in such patients.

Influence on the ability to drive vehicles and complex mechanisms

Such side reactions when taking Sonata Adamed, such as amnesia, sedation, decreased muscle strength, decreased concentration, adversely affect a person's cognitive and physical abilities. Therefore, during therapy, one should refrain from engaging in potentially hazardous activities, including from driving.

Application during pregnancy and lactation

There are no clinical observations of the efficacy and safety of using zaleplon during gestation, and therefore it is contraindicated to take Sonata Adamed capsules to pregnant women.

Prescribing the drug to women of childbearing age, the doctor must exclude their pregnancy and find a reliable means of protection against it. In each individual case, it is required to warn the patients about the obligatory immediate seeking advice upon conception during zaleplon therapy or in case of planning a pregnancy.

When it is necessary to use zaleplon in large doses during delivery, due to the pharmacological effect of the drug in newborns, hypothermia, muscle hypotension, and moderate respiratory failure may develop.

Zaleplon passes into breast milk, therefore, it is contraindicated to take Sonata Adamed during lactation.

Pediatric use

There is no information on the safety of using zaleplon in pediatrics, therefore, Sonata Adamed is contraindicated in children and adolescents under the age of 18 years.

With impaired renal function

No dose adjustment is required in patients with mild / moderate renal insufficiency; they should use Sonata Adamed with caution.

Due to the lack of information on the safety of using zaleplon in severe renal failure, the use of Sonata Adamed in this category of patients is contraindicated.

For violations of liver function

Due to the risk of developing hepatic encephalopathy, it is contraindicated to use zaleplon to treat patients with severe hepatic insufficiency.

In moderate liver failure, Sonata Adamed is contraindicated, since zaleplon at a dose of 10 mg can lead to the development of encephalopathy, and the dosage form of the drug does not allow reducing the dose.

The drug should be used with caution in patients with mild hepatic impairment.

Use in the elderly

Due to the more pronounced susceptibility of elderly patients to hypnotics, the daily dose of zaleplon for them is 5 mg. Since capsules do not allow for the required dosage, Sonata Adamed is contraindicated in elderly people.

Drug interactions

Drinks containing alcohol increase the sedative effect of zaleplon.

Taking Sonata Adamed simultaneously with antipsychotic (neuroleptic), other hypnotics, anxiolytic, sedative, antidepressant, antiepileptic drugs, general anesthesia, blockers of H ₁ -histamine receptors with a sedative effect, narcotic sedative analgesics enhances.

Simultaneous administration with narcotic analgesics can potentiate their euphoric effect, which may result in the development of drug dependence.

Cimetidine, as an inhibitor of the isoenzyme CYP3A4 and aldehyde oxidase, increases the plasma level of zaleplon by 85%.

Ketoconazole, erythromycin, and other powerful inhibitors of the CYP3A4 isoenzyme increase the plasma concentration of zaleplon, enhancing the sedative effect of Sonata Adamed, which may require a dose adjustment of the latter.

Carbamazepine, rifampicin, phenobarbital, and other powerful inducers of microsomal hepatic enzymes can reduce the effectiveness of zaleplon by 25%.

Due to the low therapeutic index of digoxin and warfarin, zaleplon does not affect their pharmacodynamic and pharmacokinetic characteristics; no dose adjustment of these drugs is required.

No interaction of zaleplon with ibuprofen and venlafaxine was found.

Analogs

The analogues of the Sonata Adamed are Andante, Belsomra, Dormikum, Zolpidem, Imovan, Midazolam, Nitrazepam, Oniria, Snovitel, Somnol, Thorson, etc.

Terms and conditions of storage

Store in original packaging at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 4 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about the Sonata Adamed

Currently, it is almost impossible to find reviews of Sonata Adamed from patients taking this drug to improve sleep.

According to scientific studies published in the European Journal of Pharmacology, the active component of the drug - zaleplon, in comparison with other hypnotics, acts more narrowly, is faster excreted from the body and practically does not affect the quality of sleep, it just helps to fall asleep faster. The half-life of zaleplon is the shortest of all substances of the non-benzodiazepine group and is only 1 hour. Therefore, Sonata Adamed usually does not cause daytime sleepiness and does not interfere with driving. It is allowed to be taken even by American aviation pilots just 6 hours before the flight (this is the shortest period of time between the allowed taking of sleeping pills and going on the flight). The sleeping pills are approved by the FDA (United States Food and Drug Administration). Since zaleplon belongs to the sleeping pills of the last generation, it is it that experts recommend taking it for problems with falling asleep.

Price for Sonata Adamed in pharmacies

Estimated price of Sonata Adamed, 10 mg capsules, 10 pcs. in packaging, when ordering from an online pharmacy, it can be 733 rubles. The cost of the drug in pharmacy chains is up to 856 rubles.

Sonata Adamed: prices in online pharmacies

Drug name Price Pharmacy

Sonata Adamed capsules 10mg 10 pcs. RUB 417 Buy

Sonata Adamed 10 mg capsules 10 pcs. RUB 417 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!