Buy Zaleplon (Sonata) 10 Mg Tablets - SkyPanaceaCom

Buy Zaleplon (Sonata) 10 Mg Tablets - SkyPanaceaCom





 


 


Indications and usage:


 


Sonata (Zaleplon) sleeping pills are indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies. It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.


 


 


Dosage and administration:


 


The dose of Sonata or Hyplon should be individualized. The recommended dose of Zaleplon pills for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Sonata appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.


 


Zaleplon (Sonata) should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep. Taking Sonata with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Sonata on sleep latency.


 


 


Dosage forms and strengths:


 


Sonata (Zaleplon) capsules 5 mg: opaque green cap and opaque pale green body with "5 mg" on the cap and "SONATA" on the body.


 


Sonata (Zaleplon) capsules 10 mg: opaque green cap and opaque light green body with "10 mg" on the cap and "SONATA" on the body.


 


 


Overdosage:


 


Signs and symptoms


 


Signs and symptoms of overdose by Sonata (Zaleplon) capsules effects of CNS depressants can be expected to present as exaggerations of the pharmacological effects noted in preclinical testing. Overdose is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death.


 


Loss of consciousness, in addition to signs and symptoms consistent with CNS depressants as described above, have been reported following zaleplon overdose. Individuals have fully recovered from zaleplon overdoses of greater than 200 mg (10 times the maximum recommended dose of zaleplon). Rare instances of fatal outcomes following overdose with zaleplon, most often associated with overdose of additional CNS depressants, have been reported.


 


Recommended treatment


 


General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Animal studies suggest that flumazenil is an antagonist to zaleplon. However, there is no pre-marketing clinical experience with the use of flumazenil as an antidote to a Sonata overdose. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.


 


Poison control center


 


As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.


 


 


Contraindications:


 


Hypersensitivity to zaleplon or any excipients in the formulation.


 


 


Warnings:


 


Complex sleep behaviors


CNS-Depressant effects and next-day impairment


Need to evaluate for co-morbid diagnoses


Severe anaphylactic and anaphylactoid reactions


Abnormal thinking and behavioral changes


Withdrawal effects


 


 


Precautions:


 


Timing of drug administration


 


Zaleplon (Hyplon, Sonata) should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep. As with all sedative/hypnotics, taking Sonata while still up and about may result in short-term memory impairment, hallucinations, impaired coordination, dizziness, and lightheadedness.


 


Use in the elderly and/or debilitated patients


 


Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. A dose of 5 mg is recommended for elderly patients to decrease the possibility of side effects. Elderly and/or debilitated patients should be monitored closely.


 


Use in patients with concomitant illness


 


Clinical experience with Sonata (Zaleplon) in patients with concomitant systemic illness is limited. Sonata should be used with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses.


 


Although preliminary studies did not reveal respiratory depressant effects at hypnotic doses of this medication in normal subjects, caution should be observed if Sonata (Zaleplon) is prescribed to patients with compromised respiratory function, because sedative/hypnotics have the capacity to depress respiratory drive. Controlled trials of acute administration of Sonata 10 mg in patients with mild to moderate chronic obstructive pulmonary disease or moderate obstructive sleep apnea showed no evidence of alterations in blood gases or apnea/hypopnea index, respectively. However, patients with compromised respiration due to preexisting illness should be monitored carefully.


 


The dose of zaleplon should be reduced to 5 mg in patients with mild to moderate hepatic impairment. It is not recommended for use in patients with severe hepatic impairment.


 


No dose adjustment is necessary in patients with mild to moderate renal impairment. Sonata has not been adequately studied in patients with severe renal impairment.


 


Use in patients with depression


 


In primarily depressed patients treated with sedative-hypnotics, worsening of depression, including suicidal thoughts and actions (including completed suicides), have been reported. As with other sedative/hypnotic drugs, this drug should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.


 


Allergic-Type Reactions FD&C Yellow No. 5


 


This product contains FD&C Yellow No. 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (Tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.


 


 


Drug interactions:


 


As with all drugs, the potential exists for interaction of zaleplon with other drugs by a variety of mechanisms.


 


CNS-active drugs (ethanol, imipramine, paroxetine, thioridazine, venlafaxine, promethazine)


Drugs that induce CYP3A4 (rifampin)


Drugs that inhibit CYP3A4


Drugs that inhibit aldehyde oxidase (diphenhydramine)


Drugs that inhibit both aldehyde oxidase and CYP3A4 (cimetidine)


Drugs highly bound to plasma protein


Drugs with a narrow therapeutic index (digoxin, warfarin)


Drugs that alter renal excretion (ibuprofen)

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  • 17 February, 2023
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