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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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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, USP contain zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. Zolpidem tartrate extended-release tablets are available in 6.25 mg and 12.5 mg strength tablets for oral administration.
Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:
Zolpidem tartrate, USP 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 consist of a two-portion tablet: one portion that releases its drug content immediately and another portion that allows a delayed release of additional drug content.
Zolpidem tartrate extended-release tablets contain the following inactive ingredients: anhydrous lactose, colloidal anhydrous silica, colloidal silicon dioxide, hypromellose, light anhydrous silicic acid, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, povidone, silica, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, tartaric acid, triethyl citrate, and titanium dioxide. Additionally, the 6.25 mg strength contains polyvinyl alcohol. The 12.5 mg strength also contains polydextrose, triacetin, and yellow iron oxide.
Dissolution test is pending.
Sources
Refresh Plus Manufacturers
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Allergan, Inc.
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Refresh Plus | American Health Packaging
2.1 Dosage in AdultsUse the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of zolpidem tartrate extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
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 normal subjects. 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 (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS DepressantsDosage adjustment 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 (5.1)].
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.
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