Product Name: Zaleplon
Common Brand Names: Sonata
Pharmaceutical Category: Anti-Depresant / Anti-Anxiety
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There is an additional general information about this medication active ingredient zaleplon:
Zaleplon is a hypnotic pyrazolopyrimidine type drug, its chemical structure is different from other benzodiazepines and sleeping pills. This medication exhibits high selectivity and low affinity for the benzodiazepine type 1 receptors. Also zaleplon has sedative, anxiolytic, muscle relaxant, anticonvulsant action.
After oral administration the absorption of Zaleplon is about 71%. The concentration in plasma is directly proportional to dose. Cmax in plasma levels achieved after 1 h. As a result of first-pass metabolism the absolute bioavailability of approximately 30%. The plasma proteins binding is about 60%. This drug is excreted in breast milk.
Zaleplon is metabolized to form several inactive metabolites.
At a daily dose of 30 mg a cumulation is not observed.
T1/2 is about 1 hour.
The medicine is excreted as metabolites in the urine and 71%, in feces - 17%.
Why is Zaleplon prescribed?
Heavy sleep disturbances with difficulty falling asleep.
Dosage and administration
Zaleplon is taken orally just before bedtime, if the patient feels that he can not sleep. It is not recommended readmission for one night.
The single dose is 10 mg. The maximum dose is 10 mg / day.
Due to a more pronounced sensitivity to hypnotic drugs the dose for elderly patients is 5 mg / day.
The duration of treatment is less than 2 weeks.
Zaleplon side effects, adverse reactions
Central nervous system: common - headache, weakness, drowsiness, dizziness, it is possible anterograde amnesia (especially when taken in high doses), accompanied by a breach of conduct, symptoms of a hidden depression, physical and psychological dependence, drug abuse; mostly in elderly patients - paradoxical reactions (anxiety, restlessness, irritability, aggression, hallucinations, impaired perception, anger, nightmares, behavioral disorders).
Severe hepatic failure, sleep apnea syndrome, severe respiratory failure, severe myasthenia, lactation, childhood and adolescence to 18 years, hypersensitivity to zaleplon.
Using during pregnancy and breastfeeding
There were no safe and well-controlled safety studies of using Zaleplon in pregnancy, therefore this medication is not recommended.
Women of childbearing age taking zaleplon should inform your doctor about planned or unwanted pregnancy.
If necessary to use zaleplon in the III trimester of pregnancy or the use of high doses during labor should bear in mind the possibility of neonatal hypothermia, hypotonia, mild respiratory distress.
Zaleplon is excreted in breast milk, so use its during lactation is contraindicated.
Category of the fetus by FDA - C.
With extreme caution use Zaleplon in patients with chronic respiratory failure, in the presence of alcohol and drug dependence.
It is not recommended taking zaleplon as the primary drug for psychosis.
This drug is not intended to treat depression and related conditions increased anxiety, as can provoke suicide attempts.
If necessary, use in patients with depression zaleplon it should be used in the lowest effective dose to avoid deliberate overdose.
If, after a brief use of the medication a sleep is not normal or sleep disorder progresses, the diagnosis should be reconsidered.
The need for taking Zaleplon more than 2 weeks are determined individually after clinical examination of the patient.
In renal insufficiency mild to moderate severity dosage adjustment is required.
There is no data on the safety of zaleplon in severe renal failure.
After several weeks of treatment it may been developed an addiction and reducing the effectiveness of this medicine.
Perhaps the development of physical and psychological dependence, the probability of which is associated with taking zaleplon in high doses, long-term use and availability of alcohol and drug dependence.
Zaleplon can be used in elderly patients, including over 75 years.
Zaleplon drug interactions
When this drug applied simultaneously with:
- antipsychotics, hypnotics, anxiolytics, antidepressants, antiepileptic drugs, anesthetics, blockers of histamine H1-receptors in the sedative effect of opioid analgesics, ethanol are increasing sedation effect of zaleplon.
- opioid analgesics may cause euphoria, which leads to dependence.
- cimetidine, which a nonspecific inhibitor of liver enzymes (aldehyde oxidase and CYP3A4), increases the concentration of zaleplon in plasma by 85% (use this combination with caution).
- selective blockers of CYP3A4 (including ketoconazole, erythromycin) increase the concentration of zaleplon in plasma levels, thus possibly increasing sedation effect of the drug (dose adjustment is required.)
- strong inducers of CYP3A4, such as rifampin, carbamazepine, phenobarbital, derivatives, can be a 25% reduction in the concentration of zaleplon in plasma and its effect.
Zaleplon in case of emergency / overdose
Symptoms: CNS depression of varying severity (from lethargy up to coma). In the case of lung toxicity - drowsiness, confusion, lethargy; in more severe cases - ataxia, hypotension, decreased blood pressure, respiratory depression; less - coma, in very rare cases - death.
Treatment: during the first hour after an overdose in a patient who is conscious should induce vomiting; patients who are unconscious, washed stomach, activated charcoal administered. It is recommended the monitoring of vital functions (breathing, pulse, blood pressure, etc.), if necessary - symptomatic and supportive therapy.