Ambien Cr
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Questions & Answers
Question
When I took Ambien as prescribed by my doctor for insomnia (I have problems falling asleep and staying asleep), I didn’t fall asleep- I stayed awake baffled by the visual disturbances it caused. I didn’t see things that weren’t actually there, but the walls appeared to be waving in a fluid-type motion.
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
Ambien CR (zolpidem tartrate extended-release tablets) is 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
Ambien CR contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Ambien CR (zolpidem tartrate extended-release tablets) is 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 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.
Ambien CR consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg Ambien CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg Ambien CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
Sources
Ambien Cr Manufacturers
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Rebel Distributors Corp.
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Rebel Distributors Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ambien Cr | Rebel Distributors Corp.
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Bryant Ranch Prepack
Ambien Cr | Bryant Ranch Prepack
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Bryant Ranch Prepack
Ambien Cr | Bryant Ranch Prepack
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Ambien Cr | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Pd-rx Pharmaceuticals, Inc.
Ambien Cr | Pd-rx Pharmaceuticals, Inc.
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Stat Rx Usa Llc
Ambien Cr | Stat Rx Usa Llc
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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St Marys Medical Park Pharmacy
Ambien Cr | St Marys Medical Park Pharmacy
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Physicians Total Care, Inc.
Ambien Cr | Physicians Total Care, Inc.
The dose of Ambien CR should be individualized.
2.1 Dosage in adultsThe recommended dose of Ambien CR for adults is 12.5 mg once daily immediately before bedtime. The total Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
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Sanofi-aventis U.s. Llc
Ambien Cr | Sanofi-aventis U.s. Llc
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 7–8 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 AMBIEN CR 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 AMBIEN CR 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 AMBIEN CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 AdministrationAMBIEN CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of AMBIEN CR may be slowed by ingestion with or immediately after a meal.
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A-s Medication Solutions Llc
Ambien Cr | A-s Medication Solutions Llc
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 7–8 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 Ambien CR 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 Ambien CR 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 Ambien CR is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 AdministrationAmbien CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Ambien CR may be slowed by ingestion with or immediately after a meal.
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0abb0285-f09c-2110-e570-542dae5fab1a&name=label1datamaxfda608.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=56060e77-c025-a079-9539-02b649fbf740&name=label1datamaxfda661.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b3e19295-1574-4832-936b-bbf41dfce009&name=ambiencr12.5mgsanofi.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fa181279-dce7-4a3f-aba8-b9c2806fdd34&name=55289205.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=40f9a7b1-b57b-4e70-b709-e81705e784a7&name=AMBIENCR12-5MGLABEL.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [St Marys Medical Park Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5a3ad211-f0a5-4238-8a03-1154fac34c86&name=AmbienCRLabel.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0d83cde7-4604-4bdd-a7cd-c31a5830514d&name=5426.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [Sanofi-aventis U.s. Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=404c858c-89ac-4c9d-8a96-8702a28e6e76&name=ambien-cr-03.jpg)
![Ambien Cr (Zolpidem Tartrate) Tablet, Coated [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5f9d40f1-f36c-420d-b212-13cad4b5236d&name=5760-1.jpg)
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