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ZolpiMIST
Overview
What is ZolpiMIST?
Zolpimist (zolpidem tartrate) Oral Spray (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 (zolpidem tartrate) Oral Spray is available as an oral solution designed to be sprayed directly into the mouth over the tongue. Each metered actuation of Zolpimist (zolpidem tartrate) Oral Spray delivers 5 mg of zolpidem tartrate in 100 ʋL. Two actuations deliver 10 mg of zolpidem tartrate. Zolpimist (zolpidem tartrate) Oral Spray includes the following inactive ingredients: artificial cherry flavor, benzoic acid, citric acid monohydrate, hydrochloric acid, neotame, propylene glycol, and purified water.
What does ZolpiMIST look like?
What are the available doses of ZolpiMIST?
Each metered actuation (one spray) of Zolpimist (zolpidem tartrate) Oral Spray delivers 5 mg of zolpidem tartrate in 100 uL. After an initial priming of 5 actuations, there are 30 or 60 metered actuations in each child-resistant container. The total number of available doses is dependent on the number of actuations per dose (1 or 2 actuations) and the frequency of priming. ()
What should I talk to my health care provider before I take ZolpiMIST?
How should I use ZolpiMIST?
Zolpimist (zolpidem tartrate) Oral Spray (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 . 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.
Use 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 . The total dose of Zolpimist (zolpidem tartrate) Oral Spray 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.
What interacts with ZolpiMIST?
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What are the warnings of ZolpiMIST?
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What are the precautions of ZolpiMIST?
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What are the side effects of ZolpiMIST?
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What should I look out for while using ZolpiMIST?
Zolpimist (zolpidem tartrate) Oral Spray is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema
What might happen if I take too much ZolpiMIST?
How should I store and handle ZolpiMIST?
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.Zolpimist (zolpidem tartrate) Oral Spray is available in a child-resistant container, which secures a bottle filled with either 4.5 mL (4.8 g) or 7.7 mL (8.2g). Each container includes a child-resistant cap and base with a metered-dose pump assembly in a bottle with a clear cap. One and two actuations of Zolpimist (zolpidem tartrate) Oral Spray deliver 5 and 10 mg of zolpidem tartrate, respectively. There are 30 metered actuations in the 4.5 mL-filled container and 60 metered actuations, after 5 initial priming actuations. Zolpimist (zolpidem tartrate) Oral Spray is supplied as:NDC Number58407-0510-30and,SizeCarton includes a child-resistant container with 4.5 mL (4.8 g) of product formulation; 30 metered actuations per container.NDC Number58407-0510-60SizeCarton includes a child-resistant container with 7.7 mL (8.2 g) of product formulation; 60 metered actuations per container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines which non-selectively bind to and activate all BZ receptor subtypes, zolpidem binds the BZ receptor preferentially with a high affinity ratio of the
This selective binding of zolpidem on the BZ receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.
Non-Clinical Toxicology
Zolpimist (zolpidem tartrate) Oral Spray is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedemaAntacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.
Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.
Zolpimist (zolpidem tartrate) Oral Spray, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Zolpimist (zolpidem tartrate) Oral Spray and of other concomitant CNS depressants may be necessary when Zolpimist (zolpidem tartrate) Oral Spray is administered with such agents because of the potentially additive effects. The use of Zolpimist (zolpidem tartrate) Oral Spray with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended .
The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpimist (zolpidem tartrate) Oral Spray is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if co-administered with other CNS depressants; or if co-administered with other drugs that increase the blood levels of zolpidem. Patients should be cautioned against driving and other activities requiring complete mental alertness if Zolpimist (zolpidem tartrate) Oral Spray is taken in these circumstances .
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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