Ambien (zolpidem)

Ambien® is a prescription insomnia medication intended for short-term use. Side effects are varied and include dizziness, nausea, and hallucinations. Many people also report having no recollection of sleepwalking, having sex, and sleep driving while on Ambien. Several generic versions of Ambien (zolpidem) are also available from Mylan, Teva and other manufacturers in 5mg and 10mg tablets.

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Side Effects & Adverse Reactions

Serious Side Effects

Serious side effects of Ambien include itching, breathing issues, facial swelling, changes in mental state and mood, including depression and thoughts of suicide, anxiety, swelling of the throat, confusion, hallucinations, and aggression. Other side effects include vomiting, sweating, panic attacks, seizures, uncontrolled crying, dry mouth, and strange dreams. (nlm.nih.gov)

Contraindications

Using Ambien with other medications (such as other sleep medicines, anxiety medications, muscle relaxants, and narcotic painkillers) that cause drowsiness and breathing complications can increase the likelihood of developing these side effects. Ambien tablets may contain lactose, so those who are intolerant to dairy should avoid this medication if it causes digestive distress.

It is dangerous to drink alcohol while taking this medication. Ambien may make you feel tired long after you wake, so be careful when you are participating in activities that require you to be alert. You should not take this medication if you aren’t able to dedicate 7 or 8 hours to sleep - if you do not get enough sleep, it is more likely that you will become drowsy after you wake up.

Sleepwalking & Other Behaviors

People have been known to engage in activities such as sleep driving and sex while on Ambien and not remember doing so later. If you have a history of sleepwalking, myasthenia gravis (a disease that causes the muscles to easily become tired and weak), or breathing disorders (including asthma and chronic obstructive pulmonary disease), you shouldn't take Ambien because you are more likely to experience these side effects.

Pregnant Women & Nursing Mothers

Pregnant women should not take Ambien unless the benefit of their use outweighs the risk of their infant developing serious side effects following birth (including breathing problems and withdrawal). Breastfeeding women also shouldn’t take Ambien, as the medicine can be harmful if transferred to a baby through breast milk. (drugs.com)

Ambien Addiction

Individuals with a predisposition for or a history of addiction should be cautious when taking Ambien because it can be addictive.

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Legal Issues

A class action lawsuit was filed in 2006 against the makers of Ambien by patients that engaged in sleepwalking and binge eating while on the medication. In addition, the lawsuit includes four people that reported sleep-driving while on Ambien.

According to Susan Lask, the plaintiffs' attorney, zolpidem tartrate causes people "to walk around like zombies and do things that they will never remember". This lawsuit resulted in increased regulations from the FDA and mandated warnings be placed on medication labels. The victims of this lawsuit were not financially compensated. (npr.org)

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

October 2014

People taking Ambien tablets (zolpidem tartrate) may experience decreased consciousness and an increase in falls and injuries. Bleeding within the brain (intracranial hemorrhage) and hip fractures have been reported by patients after taking zolpidem. (fda.gov)

April 2013

Ambien shouldn’t be taken with other medications that depress the central nervous system (medications that cause a calming effect), because doing so can increase the severity of side effects. CNS (central nervous system depressants) to avoid include opioids, benzodiazepines, antidepressants, alcohol, and tricyclic medicines. Zolpidem can cause hallucinations, worsening depression, suicidal thoughts and behaviors, and withdrawal symptoms in people who suddenly decrease their dose or discontinue taking it. (fda.gov)

April 2010

Severe cases of neonatal respiratory depression (a life-threatening breathing complication in infants) have been reported in women who took Ambien at the end of their pregnancy. Women that also took other CNS (central nervous system) depressants during their pregnancy were more profoundly at risk for this complication. (fda.gov)

May 2008

Individuals with breathing problems that are prescribed Ambien, including those with sleep apnea and myasthenia gravis (a disorder characterized by weakened muscles) are more likely to incur serious allergic reactions, such as breathing complications and severe swelling. Taking zolpidem and other sedative-hypnotic medications can result in unusual changes in thinking and behavior, including sleep driving. People who start taking Ambien should be monitored closely until they know how it will affect them. Zolpidem tartrate can cause fatigue, anxiety, headache, widespread pain, infections - including urinary tract and upper respiratory, anorexia, and vomiting. (fda.gov)

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Uses

Ambien (zolpidem) is a hypnotic medication with sedative effects that treats insomnia (sleeplessness) by balancing chemicals in the brain and creating a sense of calm. Zolpidem comes in 5mg and 10mg strengths, in both immediate release (Ambien, Intermezzo, Edluar, and Zolpimist) and extended release (Ambien CR) forms.

Edluar and Intermezzo are sublingual tablets that are placed under the tongue. Zolpimist is sprayed directly into the mouth. Immediate release pills are for individuals who have difficulty falling asleep, and the extended release variation is for people who also have difficulty staying asleep. AMBIEN® 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.

Ambien is intended for the short-term treatment of sleep disorders and should not be taken for more than two weeks at a time. This medication does not work well as a long-term solution to insomnia, as the therapeutic effects of the medication decrease with continued use. (nlm.nih.gov)

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History

Ambien was first approved by the FDA to treat insomnia in 1992. In January of 2007, the FDA approved generic versions of zolpidem tartrate, manufactued by Caraco Pharmaceutical Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Mutual Pharmaceutical Company Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Carlsbad Technology Inc., Roxane Laboratories Inc., Lek Pharmaceuticals, Mylan Pharmaceuticals Inc., Dr. Reddy's Laboratories Ltd., and Genpharm Inc. The drug is currently markted by Sanofi-Aventis U.S. LLC, a subsidiary of Sanofi-Aventis, a multinational french pharmaceutical company.

In January 2013, the FDA ordered that the recommended dosage of Ambien for women be reduced by fifty percent, as the medication metabolizes slower in women than previously believed. (nytimes.com)

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Other Information

AMBIEN (zolpidem tartrate) is a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 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.

Each AMBIEN tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.

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Ambien Manufacturers

A-s Medication Solutions Llc

Ambien | A-s Medication Solutions Llc

2.1 Dosage in Adults
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 [see Warnings and Precautions (5.1)]. The total dose of AMBIEN 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 Populations
Elderly 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 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 Depressants
Dosage adjustment may be necessary when AMBIEN is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of AMBIEN may be slowed by ingestion with or immediately after a meal.

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Rebel Distributors Corp.

Ambien | Rebel Distributors Corp.

The dose of Ambien should be individualized.
2.1 Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.
2.2 Special populations
Elderly 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 in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.3 Use with CNS depressants
Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 Administration
The effect of Ambien may be slowed by ingestion with or immediately after a meal.

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Ambien | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

The dose of Ambien CR should be individualized.
2.1 Dosage in adults
The 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 populations
Elderly 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 depressants
Dosage 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 Administration
Ambien 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 | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

The dose of Ambien should be individualized.
2.1 Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.
2.2 Special populations
Elderly 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 in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.3 Use with CNS depressants
Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 Administration
The effect of Ambien may be slowed by ingestion with or immediately after a meal.

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Stat Rx Usa Llc

Ambien | Stat Rx Usa Llc

The dose of Ambien should be individualized.
2.1 Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.
2.2 Special populations
Elderly 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 in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.3 Use with CNS depressants
Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 Administration
The effect of Ambien may be slowed by ingestion with or immediately after a meal.

No Recall
Bryant Ranch Prepack

Ambien | Bryant Ranch Prepack

The dose of Ambien should be individualized.
2.1 Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.
2.2 Special populations
Elderly 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 in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.3 Use with CNS depressants
Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
2.4 Administration
The effect of Ambien may be slowed by ingestion with or immediately after a meal.

No Recall
A-s Medication Solutions Llc

Ambien | A-s Medication Solutions Llc

2.1 Dosage in Adults
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 [see Warnings and Precautions (5.1)]. The total dose of Ambien 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 Populations
Elderly 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 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 Depressants
Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of Ambien may be slowed by ingestion with or immediately after a meal.

No Recall
Sanofi-aventis U.s. Llc

Ambien | Sanofi-aventis U.s. Llc

2.1 Dosage in Adults
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 [see Warnings and Precautions (5.1)]. The total dose of AMBIEN 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 Populations
Elderly 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 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 Depressants
Dosage adjustment may be necessary when AMBIEN is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of AMBIEN may be slowed by ingestion with or immediately after a meal.

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