AMBIEN CR zolpidem tartrate tablet coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

zolpidem tartrate (UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

zolpidem tartrate

Composition:

zolpidem tartrate 12.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

AMBIEN CR - ZOLPIDEM TARTRATE TABLET, COATED
ST MARYS MEDICAL PARK PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMBIEN CR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMBIEN CR.
AMBIEN CR (ZOLPIDEM TARTRATE EXTENDED-RELEASE) TABLETS - CIV
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Ambien CR is indicated for the treatment of insomnia characterized by
difficulties with sleep onset and/or sleep
maintenance. (1)
DOSAGE AND ADMINISTRATION
Adult dose: 12.5 mg once daily immediately before bedtime (2.1)
Elderly/debilitated/hepatically impaired patients: 6.25 mg once daily
immediately before bedtime (2.2)
Tablets to be swallowed whole, not to be crushed, divided or chewed.
Should not be taken with or immediately after a
meal (2.4)
DOSAGE FORMS AND STRENGTHS
6.25 mg and 12.5 mg extended-release tablets. Tablets not scored (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem tartrate or to any of the inactive
ingredients in the formulation (4)
WARNINGS AND PRECAUTIONS
Need to evaluate for co-morbid diagnoses: Revaluate if insomnia
persists after 7 to 10 days of use (5.1)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not rechallenge if
such reactions occur (5.2)
Abnormal thinking, behavioral changes, complex behaviors: May include
"sleep-driving" and hallucinations.
Immediately evaluate any new onset behavioral changes (5.3)
Depression: Worsening of depression or, suicidal thinking may occur.
Prescribe the least amount feasible to avoid
intentional overdose (5.3, 5.6)
Withdrawal effects: Symptoms may occur with rapid dose reduction or
discontinuation (5.4, 9.2)
CNS depressant effects: Use can impair alertness and motor
coordination. If used in combination with other CNS
depressants, dose reductions may be needed due to additive effects. Do
not use with alcohol (2.3, 5.5)
Elderly/debilitated patients: Use lower dose due to impaired motor,
cognitive performance and increase