Sonata Capsules (Hard Gelatin)
Zaleplone
5mg
WYETH MEDICA IRELAND
| Pack size | 14's (7's Blister x 2) |
|---|---|
| Dispensing mode | CD |
| Source | IRELAND |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 21.00 AED |
Available as:
Indications
Sonata Capsules (Hard Gelatin) is used for:
Insomnia
Adult Dose
Oral
Insomnia
Adult: 5-10 mg before bedtime. Max: 20 mg daily.
Elderly: >65 yr: 5 mg before bedtime. Max: 10 mg daily.
Hepatic impairment: Mild to moderate: 5 mg at bedtime. Severe: Contra-indicated.
Child Dose
Not recommended
Renal Dose
Renal Impairment
Mild to moderate impairmet: No dose adjustment necessary
Severe impairment: Not studied
Administration
May be taken with or without food. Do not take w/ or immediately after a heavy or high fat meal.
Contra Indications
Hypersensitivity. Severe hepatic impairment. Lactation.
Precautions
May precipitate new psychiatric abnormalities. Depression; hepatic impairment. History of drug or alcohol dependence or abuse, elderly and debilitated patients. Childn <18 yr. Pregnancy. May impair ability to drive or operate machinery. Do not take zaleplon if there is <4 hr of sleep. Dose reduction or withdrawal of drug should be done gradually.
Pregnancy-Lactation
Pregnancy Category: C
Lactation: small amount secreted in breast milk, not recommended
Interactions
Additive CNS effects may occur with CNS depressants e.g. TCA, alcohol, antihistamines, narcotic analgesics, thioridazine and diphenhydramine. Cytochrome P450 CYP3A4 inducers e.g. rifampicin, phenytoin, carbamazepine and phenobarbital decrease zaleplon concentrations. Increased zaleplon concentration with cimetidine and CYP 3A4 inhibitors e.g. erythromycin, ketoconazole.
Adverse Effects
Side effects of Zaleplone :
>10%
Headache (38%)
1-10%
Dizziness (7-9%), Nausea (6-8%), Abdominal pain (6%), Weakness (5-7%), Dysmenorrhea (3-4%), Eye pain (3-4%), Amnesia (2-4%), Parasthesia (3%), Tremor (2%)
<1%
Fever, Photosensitivity, Anorexia, Colitis, Periphipheral edema, Amnesia, Anxiety, Depersonalization, Hallucination, Hypesthesia, Vertigo, Epistaxis, Abnl vision, Ear pain, Hyperacusis, Parosmia
Mechanism of Action
Zaleplon, a pyrazolopyrimidine, is a sedative and hypnotic agent structurally unrelated to the benzodiazepines and other sedative-hypnotic agents. It is shown to interact with GABA subtype A complex by binding selectively to benzodiazepine type 1 receptor. It reduces sleep latency without affecting sleep duration.
Note
Sonata 5mg Capsules (Hard Gelatin) manufactured by WYETH MEDICA IRELAND. Its generic name is Zaleplone. Sonata is availble in United Arab Emirates.
Farmaco UAE drug index information on Sonata Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.