SANVAL

Active material: Zolpidem
When ATH: N05CF02
CCF: Sleeping pills
ICD-10 codes (testimony): F51.2
When CSF: 02.07.01.03
Manufacturer: LEK d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Pills, coated light pink, film; round, lenticular.

Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, Colloidal anhydrous silica, magnesium stearate, gipromelloza, hydroksypropyltsellyuloza, talc, macrogol 400, iron oxide, Titanium dioxide, carnauba wax.

10 PC. – blisters (2) – packs cardboard.

Pills, coated white or nearly white, film; round, lenticular, with Valium on one side.

Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, Colloidal anhydrous silica, magnesium stearate, gipromelloza, hydroksypropyltsellyuloza, talc, macrogol 400, Titanium dioxide, carnauba wax.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.

Pharmacological action

Sleeping pills, belonging to the group imidazopyridines. It has a sedative effect, wherein the anxiolytic, central muscle relaxant and anticonvulsant effect expressed slightly.

Excited benzodiazepine ω-receptor alpha-subunit of GABA-receptor complexes, localized in lamina IV sensory-motor areas of the cortex, reticular parts of the substantia nigra, thalamus ventral thalamic complex, Bridge, globus pallidus, etc.. Interaction with ω-receptors leads to neuronal ionoformnyh opening channels for chlorine ions.

Use of the drug shortens the time to fall asleep, reduces the number of night awakenings, It increases the total duration of sleep and improve its quality. Extends sleep stage II and stage of deep sleep (III and IV).

Hypnotic effect develops rapidly. It does not cause drowsiness during the day.

Pharmacokinetics

Absorption and distribution

After oral zolpidem is rapidly absorbed from the gastrointestinal tract. The time to reach C_max in plasma is 0.5 – 3 no. The bioavailability of zolpidem up 70%.

There is a linear relationship between the magnitude of the dose and plasma concentration.

Plasma protein binding is 92%.

Metabolism and excretion

It is metabolized in the liver with the formation of three inactive metabolites. It does not induce liver enzymes.

The metabolites are excreted in the urine (56%) and faeces (37%). T_1/2 is 0.7 – 3.5 no.

Pharmacokinetics in special clinical situations

In the elderly the clearance in the blood plasma can be reduced without a significant increase in T_1/2 (average 3 no), wherein C_max increases by 50%.

When expressed renal impairment the clearance increases slightly.

If abnormal liver function increases the bioavailability, T_1/2 increases to 10 no.

Testimony

Sleep disorders:

- Difficulty falling asleep;

- Early and nocturnal awakening.

Dosage regimen

The drug is taken orally. Dose and duration of treatment set individually.

A typical daily dose is 10 mg at bedtime; if necessary, the dose can be increased to 15 mg, However, it should not exceed 20 mg.

To patients aged 65 years and hepatic dysfunction starting dose is 5 mg; if necessary, it can be increased to 10 mg.

Sanval^® It should be taken immediately before bedtime. The course of treatment should not exceed 4 of the week.

Side effect

From the digestive system: often (>1%) – stomach ache, nausea, vomiting, diarrhea.

CNS: headache, confusion, memory impairment, drowsiness, impaired coordination of movements, euphoria, nightmares, dizziness and diplopia; rarely (<1%) – excitation, hallucinations, paresthesia, stupor.

Allergic reactions: skin rash, itch.

Other: rarely (<1%) – Sweating, paleness, orthostatic hypotension.

With prolonged use may develop drug dependence.

The frequency of side effects depends on the dose. Side effects were more common in women, than men.

Contraindications

- Hypersensitivity to zolpidem.

FROM caution should appoint Sanval^® chronic obstructive pulmonary disease (in the acute phase), respiratory failure, myasthenia, hepatic / renal failure, alcoholism, drug abuse or drug dependency history, depression.

Pregnancy and lactation

Caution should be used Sanval^® Pregnancy and lactation.

IN experimental studies Study on reproduction in animals showed no risk of adverse effects on the fetus.

There are no adequate and well-controlled studies of the drug Sanval^® during pregnancy was conducted.

The patient should be warned about, if she is planning a pregnancy, or become pregnant during treatment Sanvalom^®, and if she is breastfeeding, Be sure to inform your doctor.

Cautions

In connection with the depressing effect on the central nervous system and the rapid onset of effect Sanval^® It should be taken immediately before bedtime.

Despite, clinical studies have not revealed inhibitory effect of zolpidem on the breath, Caution should be exercised when administering the drug to patients with impaired respiratory function. Sanval^®, as well as formulations of the benzodiazepine, can cause respiratory disorders in patients, sleep apnea.

Zolpidem may further reduce muscle tone in patients with myasthenia gravis, therefore such patients during treatment Sanvalom^® should be under close medical supervision.

It is necessary to establish a medical monitoring of patients, prone to depression, since the risk of suicidal behavior during treatment Sanvala^® increases.

With prolonged use Sanvala^® It increases the risk of addiction. Duration of sleeping pills should be limited, usually, to 2-3 weeks. Patients should be warned, that if during this time will not improve sleep, should see a doctor again.

When used in recommended doses more 4 weeks of treatment withdrawal should be done gradually.

During treatment Sanvalom^® should refrain from drinking alcohol.

Use in Pediatrics

The drug is not prescribed children under the age of 15 years.

Effects on ability to drive vehicles and management mechanisms

During treatment Sanvalom^® It should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Overdose

Symptoms: disturbances of consciousness (from drowsiness to coma), respiratory depression, decrease in blood pressure.

Treatment: gastric lavage, It is recommended as an antidote to the use of flumazenil. Even with an excited expression unacceptable imposition of any sedative drugs. Hemodialysis maloeffyektivyen. If necessary spend symptomatic therapy in hospital.

Drug Interactions

When concomitant administration Sanvala^® and means, CNS depressants, eg, Opioid analgesics, antitussives, neuroleptics, hypnotics (ʙarʙituratov), Some tranquilizers and antidepressants, antihistamines, klonidina, can enhance their inhibitory effect on the central nervous system.

Flumazenil removes sleeping pills Sanvala^®.

Anxiolytics (trankvilizatorы) benzodiazepines, used in patients receiving Sanvala^®, increase the risk of drug dependence.

Sanval^® while the application increases the effect of imipramine and chlorpromazine and extends T_1/2 chlorpromazine (chlorpromazine increases the incidence of drowsiness and anterograde amnesia), lowers C_max imipramine.

Ketoconazole and ritonavir may increase the sedative effect Sanvala^®, tk. they reduce the clearance and metabolism of zolpidem.

Rifampicin, conversely, Zolpidem reduces the concentration in plasma and, Consequently, its action (perhaps, due to increased metabolism).

Alcohol dampening effect Sanvala^® CNS.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.