Ambien: Legal Information and FAQ

Ambien is a prescription sleep medication used to treat insomnia and other sleep problems. Sanofi-Aventis designed Ambien as an alternative to traditional sleeping pills. The medication guide for Ambien identified the drug as a central nervous system depressant or a “zolpidem product.”

While Ambien is the brand name for this medication, the generic drug is known as zolpidem tartrate. The U.S. Food and Drug Administration (FDA) first approved Ambien in 1999. Sanofi-Aventis U.S. LLC manufactures and distributes the drug.

This article outlines risks, side effects, and legal information for Ambien. You’ll also find answers to common questions about the drug’s usage and safety concerns.

Pharmaceutical companies have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you have suffered a serious injury after using Ambien or another prescription drug, you may have a personal injury claim. Contact an attorney near you for legal advice and next steps.

Is Ambien a Safe Sleep Drug?

In most cases, Ambien is safe if you use it as your doctor instructs. However, the drug does have a significant impact on your central nervous system. You may still suffer side effects even if you take the proper dose.

Some changes in patients taking Ambien are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme—such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

It’s important to talk to your healthcare provider if you experience any of these side effects:

• Short-term memory loss
• Abnormal thoughts
• Suicidal thoughts
• Sleep-driving
• You don’t remember what you did the next day

Ambien acts as a sedative-hypnotic. This means you may not always remember what you did while under the drug’s effect.

If you feel sick after using Ambien, contact your healthcare provider. You can also contact a personal injury lawyer, as you may have a claim against the drug manufacturer, Sanofi-Aventis U.S. LLC.

Ambien Side Effects

Most patients using Ambien only experience excessive sleepiness. But if you aren’t comfortable with the common side effects, your doctor can explain whether alternate treatment options are available. This is a good idea if the side effects are worsening.

Besides the serious side effects of Ambien listed above, you may also experience:

• Severe or persistent drowsiness
• Headaches
• Dizziness and loss of coordination
• Blurred vision or other vision problems
• A “drugged” feeling
• Upset stomach, vomiting, constipation, diarrhea, gas, heartburn
• Changes in appetite
• Stomach pain or tenderness
• Burning or tingling in the hands, arms, feet, or legs
• Cold symptoms
• Fever
• Shaking of a part of the body that you cannot control
• Unusual dreams
• Dry mouth or throat
• Pain or pressure in the face
• Ringing, pain, or itching in the ears
• Eye redness
• Muscle aches or cramps
• Joint, back, or neck pain
• Rash, hives, and itching
• Pounding heartbeat
• Chest pain

Side effects are more likely to occur in elderly patients, who are usually more sensitive than younger adults. Tell your prescribing medical professional immediately if you experience any of these adverse effects.

What To Know Before Taking Ambien

Ambien should only be used for short periods (one or two days) and generally for one or two weeks. Taking Ambien may cause you to feel drowsy, dizzy, lightheaded, or less alert. You should check with your doctor immediately if you feel clumsy or unsteady. Also, do not operate heavy machinery or perform tasks requiring coordination while taking Ambien.

Because it can cause emotional or negative memories, you should consult with your healthcare professional if you have unusual or strange thoughts while taking Ambien. Ambien is habit-forming, so your healthcare professional may want you to gradually reduce the amount you take before discontinuing use.

As with any other medication, there is a risk of Ambien addiction. This is especially true if you are taking high doses. You may experience withdrawal symptoms. After discontinuation, you may experience rebound amnesia for several nights.

Sleepwalking and Sleep-Eating

Media sources have reported occurrences of sleepwalking and sleep-related eating in patients who may also be taking Ambien. The media has also reported that a number of patients have taken Ambien and experienced temporary memory loss, unable to remember events that occurred while they used the drug.

Sanofi-Aventis issued responses to these stories, both in the media and on their website. The company stated that, while sleepwalking has occurred during treatment with Ambien, the instances reported cannot be systematically linked to the product. Furthermore, the company asserted that the U.S. prescribing information remains accurate: somnambulism (sleep-walking) is a possible rare adverse event.

Ambien’s Risks: FDA Warnings and Legal Responses

To avoid legal action, Sanofi-Aventis U.S. LLC issued a statement indicating that, while sleepwalking has occurred during treatment with Ambien, it is a rare adverse event. They also claimed that there are no systemic links to their product. If you take the drug for short-term use, you shouldn’t experience any problems.

But in 2013, the FDA issued a statement recommending that patients taking Ambien avoid driving the day after using Ambien CR.

Some patients may experience increased emotional and negative memories when taking Ambien. According to a 2010 study in the U.S. News and World Report, experts have linked Ambien to an increased early death rate in those who take Ambien regularly.

Does Ambien Cause Amnesia?

Ambien and other sleep medicines like Xanax can cause temporary memory loss or amnesia. A patient may forget what happened after taking the Ambien and before it wears off. To avoid memory problems, only take Ambien before a whole night’s sleep of at least 7-8 hours.

What Should I Tell My Healthcare Professional Before They Prescribe Ambien?

Your healthcare professional needs specific information before they prescribe Ambien. Some of this information includes:

• If you have or have had any unusual or allergic reaction to Ambien (zolpidem), or if you are allergic to any other substances (foods, preservatives, or dyes)
• History of drug or alcohol abuse, or a dependence on certain drugs
• Whether you are currently using opioids
• If you have any severe medical conditions such as emphysema, asthma, bronchitis, kidney disease, liver disease, or a chronic lung disease
• Presence of sleep apnea (breathing problems during sleep)
• Any mental health issues that may prevent you from taking sleep aids, including depression
• Whether you’re pregnant, may become pregnant, or are breastfeeding

Although Ambien has not been studied in pregnant women, animal studies have shown that it may slow the development of offspring when the mother is given doses many times higher than the human dose. Although Ambien passes into breast milk, it has not been reported to cause problems in nursing babies.

Are There Interactions Between Ambien and Other Drugs or Food?

Ambien and other medicines can interact with each other. You should never take Ambien if you are taking another zolpidem product because they are both central nervous system depressants. When taken together, they can cause death.

Always tell your prescribing physician about other medicines you take. This includes other non-prescription medications, vitamins, and even herbal supplements. Inform your doctor if you drink alcohol or have taken another zolpidem product.

What Are My Legal Options if Ambien Has Harmed Me?

While most medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured by the drug. These types of claims fall under a legal theory called product liability.

If you or a loved one believes Ambien has caused you harm, first seek appropriate medical treatment. You may also want to consult with an experienced attorney to determine if you have a valid legal claim.

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about their experience with personal injury cases involving dangerous drugs.