Zopim Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Zolpidem hemitartrate

Indications/Uses

Insomnia.

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Dosage/Direction for Use

Adult 10 mg daily taken before bedtime. Elderly or w/ hepatic insufficiency 5 mg daily. Max: 10 mg daily. Duration: Occasional insomnia eg, during trip 2-5 days. Transient insomnia eg, during troubled period 2-3 wk.

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Overdosage

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Administration

May be taken with or without food: Do not take w/ or immediately after meals if fast sleep onset is required.

Contraindications

Hypersensitivity. Obstructive sleep apnoea, myasthenia gravis, acute &/or severe resp depression. Severe hepatic insufficiency. Childn or patients w/ psychotic illness.

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Special Precautions

Anaphylaxis & angioedema. Discontinue use if psychiatric & paradoxical reactions occur. Complex sleep-related reactions; depression; history of drug or alcohol abuse & psychiatric disorders; rebound insomnia. May develop tolerance & dependence; induce anterograde amnesia. Avoid abrupt w/drawal. Co-administration w/ alcohol & other CNS depressants. May affect ability to drive & use machines. Hepatic insufficiency. Pregnancy. Not recommended during lactation. Childn <18 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Daytime drowsiness, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, gait disturbances or diplopia, GI disturbances, changes in libido, skin reactions, amnesia, psychiatric & paradoxical reactions, depression.

Drug Interactions

Additive effect of decreased alertness w/ imipramine, chlorpromazine. Additive effect on psychomotor performance w/ chlorpromazine, alcohol. Increased t_1/2 w/ fluoxetine. Increased C_max & decreased T_max w/ sertraline. Enhanced CNS-depressant effects w/ CNS-active drugs. Increased AUC_0->∞ w/ itraconazole. Reduced AUC, C_max, t_1/2 & pharmacodynamic effects w/ rifampin.

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Storage

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Description

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Action

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MIMS Class

Hypnotics & Sedatives

ATC Classification

N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.

Regulatory Classification

Presentation/Packing

Form

Zopim FC tab 10 mg

Packing/Price

10 × 10's

Zopim

zolpidem

Manufacturer:

Taiwan Biotech

Distributor:

SS Health