Zolpidem Sandoz

Zolpidem Sandoz





Agencia Lei Va Hong
Concise Prescribing Info
Zolpidem tartrate
Short-term treatment of insomnia in adults in situations where insomnia is debilitating or causing severe distress.
Dosage/Direction for Use
10 mg daily taken once immediately before bedtime w/ at least 7-8 hr before planned time of awakening. Max: 10 mg once daily.
Hypersensitivity. Obstructive sleep apnoea, myasthenia gravis, severe hepatic insufficiency, acute &/or severe resp depression. Psychotic illness. Childn.
Special Precautions
Next-day psychomotor impairment if taken <8 hr before performing activities that require mental alertness; higher than recommended dose is taken; co-administration w/ other CNS depressants, drugs increasing zolpidem blood levels, alcohol or illicit drugs. Patients w/ compromised resp function; history of drug or alcohol use; depression. Not recommended for primary treatment of psychotic illness. Withdrawal phenomena or rebound insomnia after abrupt discontinuation. May induce anterograde amnesia. Discontinue if psychiatric & paradoxical reactions, somnambulism & associated behaviors occur. Tolerance & dependence may develop. Major influence on the ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Hallucination, agitation, nightmare; somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders eg, anterograde amnesia; diarrhoea, nausea, vomiting, abdominal pain; back pain; upper & lower resp tract infection; fatigue.
Drug Interactions
Enhanced sedative effect w/ alcohol. Enhancement of central depressive effect w/ antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anaesth & sedative antihistamines. Increased blood levels w/ fluvoxamine, ciprofloxacin. Enhanced euphoria w/ narcotic analgesics. Enhanced activity w/ CYP450 inhibitors. Decreased pharmacodynamic effect w/ CYP3A4 inducer eg, rifampicin & St. John's Wort. Prolonged elimination t½, increased total AUC, & decreased apparent oral clearance w/ ketoconazole (potent CYP3A4 inhibitor).
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Zolpidem Sandoz FC tab 10 mg
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