Zodorm

Zodorm

zolpidem

Manufacturer:

Unipharm

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Zolpidem
Indications/Uses
Short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.
Dosage/Direction for Use
Initially 5 mg for women & 5 or 10 mg for men, once per night immediately before bedtime w/ at least 7-8 hr remaining before the planned time of awakening. Do not re-administer during the same night. Can be increased to max 10 mg once daily.
Contraindications
Hypersensitivity. Obstructive sleep apnoea. Myasthenia gravis. Severe hepatic insufficiency. Acute &/or severe resp depression. Should not be prescribed for childn or patients w/ psychotic illness.
Special Precautions
CNS depressant effects. Potential to cause severe allergic reactions & complex sleep-related behaviours. Long-term use is not recommended. Risk of next-day psychomotor impairment. Patients w/ compromised resp function; hepatic impairment; elderly; patients w/ history of drug or alcohol abuse; patients exhibiting symptoms of depression. Not recommended for the primary treatment of psychotic illness. Tolerance, abuse &/or physical & psychological dependence may develop. Risk of w/drawal phenomena or rebound upon abrupt discontinuation. May induce anterograde amnesia. Risk of other psychiatric & paradoxical reactions eg, restlessness, exacerbated insomnia, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, abnormal behaviour & other adverse behavioural effects, especially in the elderly. Reports of somnambulism & associated behaviours. Concomitant use w/ opioids. Do not take together w/ alcohol or other medicines that have an effect on mental function &/or CNS. Major influence on the ability to drive & use machines. Do not drive or perform activities that require mental alertness until 8 hr after taking zolpidem. Not recommended in pregnancy & lactation.
Adverse Reactions
Hallucination, agitation, nightmare, depression; somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders eg, anterograde amnesia; diarrhoea, nausea, vomiting, abdominal pain; back pain; URTI, lower resp tract infection; fatigue.
Drug Interactions
Enhanced sedative effect w/ alcohol. Enhanced central depressive effect w/ antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesth, sedative antihistamines. Enhanced euphoria w/ narcotic analgesics, leading to an increase in psychological dependence. Additive CNS depressant effect w/ opioids. Increased blood levels w/ fluvoxamine; ciprofloxacin. Decreased blood levels w/ CYP3A4 inducers eg, rifampicin, St. John's Wort. Enhanced sedative effects w/ ketoconazole (potent CYP3A4 inhibitor). CYP450 inhibitors may enhance the activity of benzodiazepines & benzodiazepine-like agents.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Presentation/Packing
Form
Zodorm FC tab 10 mg
Packing/Price
100's
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