Zolpimist
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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Zolpimist (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has 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.
History
There is currently no drug history available for this drug.
Other Information
Zolpimist (zolpidem tartrate) is a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. 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 is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.89.
Zolpimist is available as an oral solution designed to be sprayed directly into the mouth over the tongue. Each metered actuation of Zolpimist delivers 5 mg of zolpidem tartrate in 100 μL. Two actuations deliver 10 mg of zolpidem tartrate. Zolpimist includes the following inactive ingredients: artificial cherry flavor, benzoic acid, citric acid monohydrate, hydrochloric acid, neotame, propylene glycol, and purified water.
Sources
Zolpimist Manufacturers
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Ecr Pharmaceuticals
![Zolpimist (Zolpidem Tartrate) Spray, Metered [Ecr Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zolpimist | Ecr Pharmaceuticals
2.1 Dosage in AdultsUse the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 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 Zolpimist should not exceed 10 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 Zolpimist in both of these patient populations is 5 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 Zolpimist is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 AdministrationZolpimist is packaged in a child-resistant container. For detailed instructions on how to use Zolpimist, refer to the Patient Instructions for Use (following the Medication Guide). Zolpimist must be primed before it is used for the first time. To prime, patients should be told to point the black spray opening away from their face and other people and spray 5 times. For administration, the child-resistant container should be held upright with the black spray opening pointed directly into the mouth. The patient should fully press down on the pump to make sure a full dose (5 mg) of Zolpimist is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed, a second spray should be administered.
If the patient does not use Zolpimist for at least 14 days, it must be primed again with 1 spray. The patient should be referred to the Patient Instructions for Use included at the end of the Medication Guide.
The effect of Zolpimist may be slowed by ingestion with or immediately after a meal.
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