NIKP-Zolpidem

NIKP-Zolpidem

zolpidem

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Concise Prescribing Info
Contents
Zolpidem
Indications/Uses
Short-term treatment of insomnia (excluding insomnia associated w/ schizophrenia & manic depression).
Dosage/Direction for Use
Women Initially 5 mg. Men Initially 5 or 10 mg. Taken once per night, immediately before bedtime w/ at least 7-8 hr remaining before planned time of awakening. Max: 10 mg once daily. Elderly 5 mg once daily immediately before bedtime. Hepatic insufficiency 5 mg once daily immediately before bedtime.
Administration
Should be taken on an empty stomach.
Contraindications
Hypersensitivity. Patients w/ severe liver disorder; myasthenia gravis; acute narrow-angle glaucoma. Caution in use if indispensable in patients w/ acute pulmonary heart disease, pulmonary emphysema, bronchial asthma & cerebrovascular disease whose resp function is highly compromised.
Special Precautions
Debilitated patients; cardiac, liver, kidney or organic brain disorder. Avoid continuous administration. May result in sleepiness & decreased alertness, concentration & reflexive motor skills in the following morning. May cause worsening of depression & suicidal thoughts & actions in depressed patients. Do not drive or perform activities that require mental alertness until 8 hr after intake. Pregnancy & lactation. Childn, elderly.
Adverse Reactions
Dependence & withdrawal symptoms eg, rebound insomnia or irritability. Psychiatric symptoms & disturbances of consciousness (eg, delirium, confusion, somnambulism, hallucinations, excitation, disinhibition, depressed level of consciousness) may occur. Transient anterograde amnesia & twilight states. Resp depression; carbon dioxide narcosis. Hepatic function disorder & jaundice accompanied by increased AST, ALT, γ-GTP & Al-P may occur.
Drug Interactions
Additive resp depression w/ narcotics. Additive CNS depression w/ CNS depressants eg, phenothiazine derivatives, barbiturate derivatives; alcohol. Decreased blood conc w/ rifampicin. Sedative & anticonvulsant effects may change or persist for a longer period of time w/ flumazenil.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Presentation/Packing
Form
NIKP-Zolpidem tab 10 mg
Packing/Price
10 × 10's
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