ZOLPIDEM TARTRATE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)

Available from:

McKesson Contract Packaging

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE.
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Indications and Usage (1) 03/2007
Warnings and Precautions
Severe Anaphylactic and anaphylactoid reactions (5.2) 03/2007
Abnormal thinking and behavioral changes 03/2007
Special Populations (5.6) 03/2007
INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment
of insomnia characterized by difficulties with sleep
initiation. Zolpidem tartrate tablets have been shown to decrease
sleep latency for up to 35 days in CONTROLLED
CLINICAL STUDIES. (1) (1)
DOSAGE AND ADMINISTRATION
Adult dose: 10 mg once daily immediately before bedtime (2.1)
Elderly/Debilitated patients/Hepatic Impairment: 5 mg once daily
immediately before bedtime (2.2)
Downward dosage adjustment may be necessary when used with CNS
depressants (2.3)
Should not be taken with or immediately after a meal (2.4)
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg TABLETS (3). Tablet not scored. (3)
CONTRAINDICATIONS
5 mg and 10 mg TABLETS (3). Known hypersensitivity to zolpidem
tartrate or to any of the inactive ingredients in the
formulation (4.1) (4)
WARNINGS AND PRECAUTIONS
Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia
persists after 7 to 10 days of use. (5.1)
Severe anaphylactic and anaphylactoid reactions: Angioedema and
anaphylazis have been reported. Do not rechallenge
if such reactions occur. (5.2)
Abnormal thinking, behavioral changes and 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 reduc