Stilnox CR

Stilnox CR

zolpidem

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Zolpidem tartrate
Indications/Uses
Short-term treatment of insomnia in adults.
Dosage/Direction for Use
Should be taken immediately before bedtime. Max treatment duration: 4 wk. Adult 12.5 mg daily. Elderly, debilitated & hepatically impaired patients 6.25 mg daily.
Administration
Should be taken on an empty stomach: Swallow whole, do not divide/chew/crush.
Contraindications
Hypersensitivity. Sleep apnoea; myasthenia gravis; acute &/or severe pulmonary insufficiency. Prior or concomitant intake w/ alcohol. Severe hepatic insufficiency. Patients who have previously experienced complex sleep behaviours after taking Stilnox CR. Childn <18 yr.
Special Precautions
Risk of tolerance, abuse &/or physical & psychological dependence upon prolonged use; rebound insomnia upon w/drawal; drowsiness & decreased level of consciousness; suicide & suicide attempts; psychiatric & paradoxical reactions; somnambulism & associated behaviours; psychomotor impairment. Patients w/ known congenital long QT syndrome; resp insufficiency; psychotic illness including depression, psychosis, schizophrenia; addiction; epilepsy; renal or hepatic impairment; elderly or debilitated patients. May induce anterograde amnesia. Do not rechallenge in patients who develop angioedema after treatment. Concomitant use w/ opioids may result in sedation, resp depression, coma & death. Avoid driving or operating machinery for 8 hr after taking Stilnox CR. Not recommended during pregnancy & lactation.
Adverse Reactions
Drowsiness, dizziness, diarrhoea, drugged feeling, headache, somnolence.
Drug Interactions
Additive central depressant effect w/ CNS depressants eg, alcohol, benzodiazepines, barbiturates, sedative/hypnotics, anxiolytics, antidepressant agents (including TCAs, MAOIs), antipsychotics (neuroleptics), phenothiazines, skeletal muscle relaxants, antihistamines, neuroleptics, antiepileptic drugs, narcotic analgesics or anaesth; opioids. Euphoric enhancement w/ narcotic analgesics. Increased risk of somnambulism & associated behaviours w/ alcohol & other CNS depressants. Additive sedative effects w/ imipramine. Decreased alertness & psychomotor performance w/ chlorpromazine. Decreased pharmacodynamic effect w/ CYP3A4 inducers (eg, rifampicin & St. John's Wort). Enhanced sedative effects w/ ketoconazole (CYP3A4 inhibitor). Increased blood levels w/ fluvoxamine (strong CYP1A2 inhibitor & moderate to weak CYP2C9 & CYP3A4 inhibitor); ciprofloxacin (moderate CYP1A2 & CYP3A4 inhibitor).
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Presentation/Packing
Form
Stilnox CR modified-release tab 12.5 mg
Packing/Price
14's
Form
Stilnox CR modified-release tab 6.25 mg
Packing/Price
14's
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