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:

Wockhardt Limited

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablet is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)]. Pregnancy Category C There are no adequate and well-controlled studies zolpidem tartrate tablets in pregnant women. Zolpidem tartrate tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse

Product summary:

Zolpidem tartrate tablets 5 mg are pink, film coated, capsule shaped tablets, debossed with "W714" on one side and plain on the other side: NDC Number                      Size 64679-714-01                      bottle of 100 64679-714-04                      bottle of 500 64679-714-02                      bottle of 1000 Zolpidem tartrate tablets 10 mg are white, film coated, capsule shaped tablets, debossed with "W715" on one side and plain on the other side: NDC Number                      Size 64679-715-01                      bottle of 100 64679-715-04                      bottle of 500 64679-715-02                      bottle of 1000 Store at controlled room temperature 20°-25° C (68°-77°F) [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
WOCKHARDT LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE
TABLETS
ZOLPIDEM TARTRATE TABLETS FOR ORAL ADMINISTRATION - CIV
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 (5.3) 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)
DOSAGE AND ADMINISTRATION
Adult dose: 10 mg immediately before bedtime (2.1)
Elderly/debilitated patients/hepatically impaired: 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. 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 diagnosis: Reevaluate 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 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 rap