ZOLPIDEM TARTRATE EXTENDED RELEASE- zolpidem tartrate tablet, film coated, extended release

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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem tartrate extended-release tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14) ] . Zolpidem tartrate extended-release tablets are 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 of zolpidem tartrate extended-release tablets in pregnant women. Zolpidem tartrate extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk

Product summary:

Zolpidem tartrate extended-release tablets, 12.5 mg are available as white to off-white round film coated tablets engraved with “A116” on one side and plain on the other side. They are supplied as follows: NDC 60760-116-30 BOTTLES OF 30 *Store at 20°C to 25°C (68°F to 77°F) [see USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

St Marys Medical Park Pharmacy
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Revised: 10/2018
Document Id: 77e68d0b-c9f6-b796-e053-2991aa0a3918
34391-3
Set id: de7a700d-2757-40c2-8e50-9a6b106ab011
Version: 4
Effective Time: 20181010
St Marys Medical Park Pharmacy

Summary of Product characteristics

ZOLPIDEM TARTRATE EXTENDED RELEASE- ZOLPIDEM TARTRATE TABLET, FILM
COATED,
EXTENDED RELEASE
ST MARYS MEDICAL PARK PHARMACY
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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.
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED
RELEASE FOR ORAL USE.
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Indications and Usage ( 1)
12/2007
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)
04/2007
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are 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 occ