Clinical and pharmacological group: & nbsp

Sleeping Pills

Included in the formulation
  • Andante®
    capsules inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Sonata® Adamed
    capsules inwards 
    ADAMED, LLC     Poland
  • АТХ:

    N.05.C.F.03   Zaleplon

    Pharmacodynamics:

    Selectively binds to ω1-receptors of the α-subunit of the GABA-receptor complex, enhancing sensitivity to the mediator, thereby increasing the frequency of opening ion-channel channels for the entry of chloride ions, which leads to hyperpolarization of the synaptic membrane, therefore, enhances the processes of inhibition in the central nervous system.

    Shortens the time of falling asleep, prolongs the duration of sleep in the first half of the night. Has sedative, anxiolytic, anticonvulsant and myorelaxing action.

    Pharmacokinetics:

    After ingestion, up to 71% is absorbed in the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 1 hour. The connection with plasma proteins is 60%.

    Penetrates into breast milk. Metabolism in the liver to inactive metabolites.

    The elimination half-life is 1 hour. Elimination by the kidneys and with feces.

    Indications:

    It is used to treat insomnia.

    VI.G40-G47.G47.0   Disturbances of falling asleep and maintaining sleep [insomnia]

    Contraindications:

    Severe respiratory and hepatic insufficiency, a symptom of sleep apnea, depression, myasthenia gravis, age to 18 years, pregnancy and lactation, individual intolerance.

    Carefully:

    The presence of alcohol and drug dependence, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - Category C. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Inside, at bedtime, 10 mg. The course of treatment should not exceed 2 weeks.

    The highest daily dose: 10 mg.

    The highest single dose: 10 mg.

    Side effects:

    Central and peripheral nervous system: headache, weakness, drowsiness, euphoria, anterograde amnesia, signs of latent depression, paradoxical reactions: excitement, aggressiveness, hallucinations, nightmares.

    Respiratory system: bronchitis, pneumonia, hiccough, dyspnea, hyperventilation.

    Hemopoietic system: anemia, eosinophilia, lymphocytosis, leukocytosis, purpura.

    The cardiovascular system: angina pectoris, arterial hypertension or hypotension, syncope, tachycardia, ventricular extrasystole, sinus bradycardia, rarely pulmonary embolism.

    Digestive system: dyspepsia, flatulence, increased appetite and body weight, rectal bleeding, melena, bruxism,increased salivation, peptic ulcer, discoloration and swelling of the tongue, ulcerative stomatitis.

    Musculoskeletal system: arthralgia, myalgia, bursitis, myositis, osteoporosis.

    Dermatological reactions: rash, photosensitivity, alopecia, melanosis.

    Sense organs: diplopia, ptosis, accommodation disorders, cataract, glaucoma, visual field defect, nystagmus, labyrinthitis.

    urinary system: cystalgia, mastalgia, dysuria, hematuria, albuminuria, urolithiasis.

    Reproductive system: decreased libido, impotence, dysmenorrhea, metrorrhagia, vaginitis.

    Allergic reactions.

    Overdose:

    Drowsiness, confusion, lethargy, ataxia, breathing disorders, coma.

    Treatment is symptomatic.

    Interaction:

    Strengthens the sedative effect of ethanol, antipsychotic drugs, hypnotics, antihistamines and narcotic analgesics.

    Cimetidine increases the concentration of zaleplon in the blood by 85%.

    Ketoconazole and erythromycin strengthen the sedative effect of zaleplon.

    Rifampicin, carbamazepine, phenobarbital derivatives reduce the effectiveness of zaleplon by 25%.

    Simultaneous use with opioid analgesics causes euphoria and forms psychic dependence.

    Special instructions:

    Do not take a second dose for 1 day. Patients with hepatic and renal insufficiency of mild and moderate severity are recommended to take half the dose - 5 mg each.

    The drug causes physical dependence, accompanied by withdrawal syndrome.

    When taking the drug is not recommended driving and working with moving machinery.

    Instructions
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