Universal reference book for medicines

Product name:
ZOLSANA (ZOLSANA)

Active substance: zolpidem

Type: Soporific drug

Manufacturer: KRKA (Slovenia) manufactured by SYNTHON (Spain)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
A hypnotic drug from the group of imidazopyridines, a specific agonist?
1- receptors of the central nervous system. Shortens the time of falling asleep, reduces the number of nocturnal awakenings, increases the duration of sleep and improves its quality. Lengthens the phase II sleep, the phase of deep sleep (III and IV), does not affect the duration of the fast sleep phase.
Central miorelaxing and anticonvulsant effects are also characteristic.

PHARMACOKINETICS
After ingestion C max in the blood plasma is observed after 0.5-3 hours. Bioavailability is about 70%.

Binding to plasma proteins - 92%.
There is a linear relationship between the dose value and the concentration of the active substance in the plasma. V d is 0.54 ± 0.02 l / kg.
Zolpidem is metabolized in the liver and in the form of inactive metabolites is excreted in the urine (56%) and feces (37%).
Does not induce microsomal liver enzymes.
T 1/2 - from 0.7 h to 3.5 h (average 2.4 h).

In elderly people, a decrease in the plasma clearance of zolpidem is possible, with T 1/2 slightly increasing (on average up to 3 hours), C max increases by 50%, V ddecreases to 0.34 ± 0.05 l / kg.

In patients with severe renal dysfunction, the clearance of zolpidem decreases slightly, other pharmacokinetic parameters do not change.

In patients with severe liver function disorders, the bioavailability of zolpidem increases, the clearance decreases slightly, T 1/2 increases to 10 hours.

INDICATIONS
Episodic, transient and chronic insomnia.

DOSING MODE
When administered orally for adults under the age of 65, a single dose is 10 mg, if necessary, it can be increased to 15-20 mg.
For patients over 65 years of age or with concomitant hepatic failure, the initial single dose is 5 mg. Take immediately before bedtime. The course of treatment - from a few days to 4 weeks.
The maximum dose: 10 mg / day.

SIDE EFFECT
From the digestive system: in some cases - abdominal pain, nausea, vomiting, diarrhea.

From the central nervous system and peripheral nervous system: depending on the dose and individual sensitivity (especially in elderly patients) - dizziness, imbalance, ataxia, headache, daytime drowsiness, attention deficit, muscle weakness, diplopia, anterograde amnesia, paradoxical or psychopathological reactions ;ricochet insomnia is possible when used in high doses or long-term treatment.

Allergic reactions: skin rash, itching.

Other: rarely - violations of sexual desire;
the development of habituation, the formation of mental and physical dependence (when applied for several weeks.
CONTRAINDICATIONS
Severe respiratory failure, nocturnal sleep apnea, severe hepatic insufficiency, children and adolescents under 15, I trimester of pregnancy, lactation (breastfeeding), hypersensitivity to zolpidem.

PREGNANCY AND LACTATION
Zolpidem is contraindicated in pregnancy and lactation (breastfeeding).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
If liver function is insufficient, it may be necessary to reduce the dose of the drug.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 15 years.

SPECIAL INSTRUCTIONS
Not recommended for myasthenia gravis.

Use with caution in patients with respiratory failure.
If the liver function is insufficient, it may be necessary to reduce the dose.
If you cancel therapy, the dose should be reduced gradually.
The likelihood of developing addiction increases with prolonged use of zolpidem.
During the treatment period against the background of therapy, do not allow alcohol.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, one should refrain from potentially dangerous activities requiring concentration of attention and high speed of psychomotor reactions.

DRUG INTERACTION
With the simultaneous use with opioid analgesics, antitussives, barbiturates, antidepressants, sedatives, antihistamines, benzodiazepine, clonidine, neuroleptics, ethanol, the development of symptoms of CNS and respiratory center depression is possible.

With simultaneous use with rifampicin, the concentration of zolpidem in the blood plasma decreases, which is accompanied by a decrease in its hypnotic effect.
The interaction is due to the induction of the CYP3A4 isoenzyme.
With the simultaneous use of CYP3A4 isoenzymes with inductors (including carbamazepine, phenytoin), it is suggested that the concentration of zolpidem in the blood plasma can be reduced.

With simultaneous application with clozapine, the risk of collapse, circulatory arrest and breathing increases.

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