Ambien 10mg by Safe Pharma
Product Description
What is Ambien?
Ambien (zolpidem) is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
Zolpidem (sold under the brand names Ambien, Ambien CR, Stilnox, and Sublinox) is a prescription medication used for the treatment of insomnia, as well as some brain disorders. It is a short-acting nonbenzodiazepine hypnotic of the imidazopyridine class that potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by binding to GABAA receptors at the same location as benzodiazepines. It works quickly (usually within 15 minutes) and has a short half-life (two to three hours).
Zolpidem has not adequately demonstrated effectiveness in maintaining sleep (unless delivered in a controlled-release form); however, it is effective in initiating sleep. Its hypnotic effects are similar to those of the benzodiazepine class of drugs, but it is molecularly distinct from the classical benzodiazepine molecule and is classified as an imidazopyridine. Flumazenil, a benzodiazepine receptor antagonist, which is used for benzodiazepine overdose, can also reverse zolpidem's sedative/hypnotic and memory-impairing effects.
As a muscle relaxant and anticonvulsant, the drug's effects are not evident until dosages 10 and 20 times those required for sedation, respectively, are reached. For that reason, zolpidem has never been approved for either muscle relaxation or seizure prevention. Such drastically increased doses are also more inclined to induce one or more of the drug's adverse side effects, including hallucinations and amnesia.
The patent in the United States on zolpidem was held by the French pharmaceutical corporation Sanofi-Aventis. On April 23, 2007, the U.S. Food and Drug Administration (FDA) approved 13 generic versions of zolpidem tartrate. Zolpidem is available from several generic manufacturers in the UK, as a generic from Sandoz in South Africa and TEVA in Israel, as well as from other manufacturers such as Ratiopharm
Medical uses:
Zolpidem is used for short-term (usually about two to six weeks) treatment of insomnia. It has been studied for nightly use up to six months in a single-blind trial published in 1991, an open-label study lasting 180 days published in 1992 (with continued efficacy in patients who had kept taking it as of 180 days after the end of the trial), and in an open-label trial lasting 179 days published in 1993.Zolpidem has not proven effective in maintaining sleep and is more used for sleep initiation problems.
Zolpidem is one of the most common GABA-potentiating sleeping medications prescribed in the Netherlands, with a total of 582,660 prescriptions dispensed in 2008.
The United States Air Force uses zolpidem as one of the hypnotics approved as "no-go pills" to help aviators and special duty personnel sleep in support of mission readiness (the other hypnotics used are temazepam and zaleplon during war time). "Ground tests" are required prior to authorization issued to use the medication in an operational situation
There is evidence that zolpidem can rouse patients from a persistent vegetative state
Important information about Ambien:
Ambien may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder.
Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not take this medicine if you have consumed alcohol during the day or just before bed.
Ambien may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
It is dangerous to try and purchase Ambien on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
Before taking Ambien:
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem. Ambien tablets may contain lactose. Use caution if you are sensitive to lactose.
To make sure you can safely take Ambien, tell your doctor if you have any of these other conditions:
kidney disease;
liver disease;
lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
sleep apnea (breathing stops during sleep);
myasthenia gravis;
a history of depression, mental illness, or suicidal thoughts; or
a history of drug or alcohol addiction.
Ambien may be habit forming and should be used only by the person it was prescribed for. Never share Ambien with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Ambien will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The sedative effects of Ambien may be stronger in older adults. Do not give this medicine to anyone younger than 18 years of age.
How should I take Ambien?
Take Ambien exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Ambien comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Never take Ambien if you do not have a full 7 to 8 hours to sleep before being active again.
Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take Ambien for longer than 4 or 5 weeks without your doctor's advice. Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.
Insomnia symptoms may also return after you stop taking Ambien. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.
Store Ambien at room temperature away from moisture and heat. Do not freeze.
What happens if I miss a dose?
Since Ambien is taken only at bedtime, you will not be on a frequent dosing schedule.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Ambien can be fatal when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
What should I avoid while taking Ambien?
Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Ambien side effects:
Ambien may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.
Stop using Ambien and call your doctor at once if you have a serious side effects:
chest pain, fast or irregular heartbeat, feeling short of breath;
trouble breathing or swallowing; or
feeling like you might pass out.
Less serious Ambien side effects may include:
daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
tired feeling, loss of coordination;
dry mouth, nose or throat irritation;
nausea, constipation, diarrhea, upset stomach;
stuffy nose, sore throat; or
headache, muscle pain.
Ambien Dosing Information:
Usual Adult Dose of Ambien for Insomnia:
Immediate release: 10 mg orally once a day immediately before bedtime. The recommended duration of Ambien therapy is generally 7 to 10 days.
If Ambien is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.
The safety of immediate release tablets has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.
Usual Geriatric Dose of Ambien for Insomnia:
Immediate release: 5 mg once a day immediately before bedtime. The recommended duration of Ambien therapy is generally 7 to 10 days. The dosage can be titrated up to 10 mg nightly if necessary depending on patient response.
Controlled release: 6.25 mg orally once a day immediately before bedtime.
If Ambien is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.
The safety of immediate release tablets has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.
What other drugs will affect Ambien?
You may need a lower dose of Ambien if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.
Tell your doctor about all other medicines you use, especially:
chlorpromazine (Thorazine);
itraconazole (Sporanox), ketoconazole (Nizoral);
rifampin (Rifadin, Rimactane, Rifater); or
antidepressants such as imipramine (Tofranil), or sertraline (Zoloft).
Do not start a new medication without telling your doctor.
What is Ambien?
Ambien (zolpidem) is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
Zolpidem (sold under the brand names Ambien, Ambien CR, Stilnox, and Sublinox) is a prescription medication used for the treatment of insomnia, as well as some brain disorders. It is a short-acting nonbenzodiazepine hypnotic of the imidazopyridine class that potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by binding to GABAA receptors at the same location as benzodiazepines. It works quickly (usually within 15 minutes) and has a short half-life (two to three hours).
Zolpidem has not adequately demonstrated effectiveness in maintaining sleep (unless delivered in a controlled-release form); however, it is effective in initiating sleep. Its hypnotic effects are similar to those of the benzodiazepine class of drugs, but it is molecularly distinct from the classical benzodiazepine molecule and is classified as an imidazopyridine. Flumazenil, a benzodiazepine receptor antagonist, which is used for benzodiazepine overdose, can also reverse zolpidem's sedative/hypnotic and memory-impairing effects.
As a muscle relaxant and anticonvulsant, the drug's effects are not evident until dosages 10 and 20 times those required for sedation, respectively, are reached. For that reason, zolpidem has never been approved for either muscle relaxation or seizure prevention. Such drastically increased doses are also more inclined to induce one or more of the drug's adverse side effects, including hallucinations and amnesia.
The patent in the United States on zolpidem was held by the French pharmaceutical corporation Sanofi-Aventis. On April 23, 2007, the U.S. Food and Drug Administration (FDA) approved 13 generic versions of zolpidem tartrate. Zolpidem is available from several generic manufacturers in the UK, as a generic from Sandoz in South Africa and TEVA in Israel, as well as from other manufacturers such as Ratiopharm
Medical uses:
Zolpidem is used for short-term (usually about two to six weeks) treatment of insomnia. It has been studied for nightly use up to six months in a single-blind trial published in 1991, an open-label study lasting 180 days published in 1992 (with continued efficacy in patients who had kept taking it as of 180 days after the end of the trial), and in an open-label trial lasting 179 days published in 1993.Zolpidem has not proven effective in maintaining sleep and is more used for sleep initiation problems.
Zolpidem is one of the most common GABA-potentiating sleeping medications prescribed in the Netherlands, with a total of 582,660 prescriptions dispensed in 2008.
The United States Air Force uses zolpidem as one of the hypnotics approved as "no-go pills" to help aviators and special duty personnel sleep in support of mission readiness (the other hypnotics used are temazepam and zaleplon during war time). "Ground tests" are required prior to authorization issued to use the medication in an operational situation
There is evidence that zolpidem can rouse patients from a persistent vegetative state
Important information about Ambien:
Ambien may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder.
Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not take this medicine if you have consumed alcohol during the day or just before bed.
Ambien may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
It is dangerous to try and purchase Ambien on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
Before taking Ambien:
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem. Ambien tablets may contain lactose. Use caution if you are sensitive to lactose.
To make sure you can safely take Ambien, tell your doctor if you have any of these other conditions:
kidney disease;
liver disease;
lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
sleep apnea (breathing stops during sleep);
myasthenia gravis;
a history of depression, mental illness, or suicidal thoughts; or
a history of drug or alcohol addiction.
Ambien may be habit forming and should be used only by the person it was prescribed for. Never share Ambien with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether Ambien will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The sedative effects of Ambien may be stronger in older adults. Do not give this medicine to anyone younger than 18 years of age.
How should I take Ambien?
Take Ambien exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Ambien comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Never take Ambien if you do not have a full 7 to 8 hours to sleep before being active again.
Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take Ambien for longer than 4 or 5 weeks without your doctor's advice. Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.
Insomnia symptoms may also return after you stop taking Ambien. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.
Store Ambien at room temperature away from moisture and heat. Do not freeze.
What happens if I miss a dose?
Since Ambien is taken only at bedtime, you will not be on a frequent dosing schedule.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Ambien can be fatal when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
What should I avoid while taking Ambien?
Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Ambien side effects:
Ambien may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.
Stop using Ambien and call your doctor at once if you have a serious side effects:
chest pain, fast or irregular heartbeat, feeling short of breath;
trouble breathing or swallowing; or
feeling like you might pass out.
Less serious Ambien side effects may include:
daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
tired feeling, loss of coordination;
dry mouth, nose or throat irritation;
nausea, constipation, diarrhea, upset stomach;
stuffy nose, sore throat; or
headache, muscle pain.
Ambien Dosing Information:
Usual Adult Dose of Ambien for Insomnia:
Immediate release: 10 mg orally once a day immediately before bedtime. The recommended duration of Ambien therapy is generally 7 to 10 days.
If Ambien is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.
The safety of immediate release tablets has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.
Usual Geriatric Dose of Ambien for Insomnia:
Immediate release: 5 mg once a day immediately before bedtime. The recommended duration of Ambien therapy is generally 7 to 10 days. The dosage can be titrated up to 10 mg nightly if necessary depending on patient response.
Controlled release: 6.25 mg orally once a day immediately before bedtime.
If Ambien is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.
The safety of immediate release tablets has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.
What other drugs will affect Ambien?
You may need a lower dose of Ambien if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.
Tell your doctor about all other medicines you use, especially:
chlorpromazine (Thorazine);
itraconazole (Sporanox), ketoconazole (Nizoral);
rifampin (Rifadin, Rimactane, Rifater); or
antidepressants such as imipramine (Tofranil), or sertraline (Zoloft).
Do not start a new medication without telling your doctor.
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