Zolonia Tablets / Film-coated
Zolpidem Tartrate
10 mg
SPIMACO (Al Qassim Pharmaceutical Plant)
| Pack size | 28 tablets |
|---|---|
| Dispensing mode | CD |
| Source | SAUDI ARABIA |
| Agent | CITY MEDICAL STORE |
| Retail Price | 35.00 AED |
Indications
Zolonia Tablets / Film-coated is used for:
Insomnia
Adult Dose
Oral
Short-term management of insomnia
Adult: As immediate release tab: 5-10 mg immediately before bedtime. Max: 10 mg/day.
Max duration of treatment: 4 wk including tapering.
Elderly: As immediate release tab: 5 mg immediately before bedtime. Max duration of treatment: 4 wk including tapering.
Hepatic impairment: As immediate release tab: 5 mg immediately before bedtime. Max duration of treatment: 4 wk including tapering. Severe: Contraindicated.
Child Dose
Not recommended
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Should be taken on an empty stomach. Do not take w/ or immediately after a meal.
Contra Indications
Severe hepatic impairment.
Precautions
Obstructive sleep apnoea, myasthenia gravis, compromised respiratory function. Patients exhibiting symptoms of depression. History of drug or alcohol abuse. Avoid abrupt withdrawal and rapid dose reduction after prolonged therapy. Re-evaluate if insomnia fail to remit after 7-10 days as this may indicate the presence of underlying psychiatric and/or medical condition. Pregnancy, lactation, childn <18 yr. Patient Counseling Patients should be warned about performing activities involving mental alertness or physical coordination after drug intake.
Lactation: Very low amounts secreted in breast milk; effect on infant unknown; use caution; advise mother to observe breastfeeding infant for lethargy, increased sedation, and changes in feeding habits
Pregnancy-Lactation
Pregnancy Category: C
Lactation: small amount secreted in breast milk, not recommended
Interactions
Flumazenil reverses the sedative/hypnotic effect of zolpidem. Increased depressant effects w/ CNS depressants (e.g. sedatives, antihistamines, alcohol). Additive effect on decreased alertness and psychomotor performance w/ imipramine and chlorpromazine. Increased plasma concentration w/ itraconazole, ketoconazole and other CYP3A4 inhibitors. May decrease plasma concentration w/ CYP3A4 inducers (e.g. carbamazepine). Reduced hypnotic effect w/ rifampicin.
Potentially Fatal: Increased risk of prolonged sedation and respiratory depression w/ ritonavir.
Adverse Effects
Side effects of Zolpidem Tartrate :
>10%
Dizziness (5-12%), Headache (7-19%), Drowsiness (6-15%)
1-10%
Allergy (4%), Hallucinations (4%), Myalgia (4%), Sinusitis (4%), Memory disorder (3%), Visual disturbance (3%), Pharyngitis (3%), Lightheadedness (2%), Palpitation (2%), Rash (2%), Constipation (2%), Depression (2%), Drowsiness (2%), Asthenia (1%), Diarrhea (1%), Dry mouth (1%), Flu-like symptoms (1%)
Potentially Fatal: Hepatitis, anaphylactic reactions, angioedema, sleep-driving (driving while not fully awake after drug intake, w/ no recollection of the event).
Mechanism of Action
Zolpidem is an imidazopyridine derivative that acts by binding to the benzodiazepine (BZD) receptors of the GABA receptor complex resulting in neuronal hyperpolarisation, action potential inhibition, increased in chloride conductance and decreased in neuronal excitability. It has strong sedative action but only minimal anxiolytic, myorelaxant and anticonvulsant properties due to its selectivity for the BZ1-receptor over the BZ2-receptor. Zolpidem has a rapid onset but short duration of hypnotic action.
Note
Zolonia 10 mg Tablets / Film-coated manufactured by SPIMACO (Al Qassim Pharmaceutical Plant). Its generic name is Zolpidem Tartrate. Zolonia is availble in United Arab Emirates.
Farmaco UAE drug index information on Zolonia Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.