Zolpidem Tartrate Extended Release
Loading...Zolpidem Tartrate Extended Release Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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)].
History
There is currently no drug history available for this drug.
Other Information
Zolpidem tartrate extended-release tablets contain zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem tartrate extended-release tablets is available in 6.25 mg and 12.5 mg strength tablets for oral administration.
Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Zolpidem tartrate extended-release tablets containing a hydrogel-matrix core that provides extended-release of the drug content.
The 6.25 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6/sunset yellow FCF aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sugar, titanium dioxide and talc. The 12.5 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sugar, titanium dioxide and triacetin.
USP Dissolution Test Pending.
Sources
Zolpidem Tartrate Extended Release Manufacturers
-
St Marys Medical Park Pharmacy
![Zolpidem Tartrate Extended Release (Zolpidem Tartrate) Tablet, Film Coated, Extended Release [St Marys Medical Park Pharmacy]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zolpidem Tartrate Extended Release | St Marys Medical Park Pharmacy
The dose of zolpidem tartrate extended-release tablets should be individualized.
2.1 Dosage in adultsThe recommended dose of zolpidem tartrate extended-release tablets for adults is 12.5 mg once daily immediately before bedtime. The total zolpidem tartrate extended-release tablets dose should not exceed 12.5 mg per day.
2.2 Special populationsElderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.3 Use with CNS depressantsDosage adjustments may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationZolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.
Login To Your Free Account