Ambien is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.
OTC Name and Overview
Manufacturer
Sanofi-Aventis, a French pharmaceutical company is the approved manufacturer of Ambien. Sanofi-Aventis was given approval on December 16, 1992 to manufacture the 5mg and 10mg strengths of the drug.
Labeled Indications
Ambien is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.
Active Ingredients
The active ingredient in Ambien is Zolpidem Tartrate.
What Is It Used For?
How Does it Work?
What are the Approved Uses?
Keeping Up To Date On Potential Dangers of Medications
Production Anecdotes / History
Precautions
- Inform your doctor if you are allergic to zolpidem, any medications, or to any of the ingredients found in Ambien.
- Inform your doctor about other medications, vitamins, supplements, or herbal product you are taking or are planning to take. Most especially, inform your doctor if you are taking St. John’s Wort, antidepressants, medications for anxiety, allergies, sedatives, or sleeping pills.
- Do not take a dose of this drug if you do not have enough time to sleep for at least 7 to 8 hours straight before you need to be active again.
- Do not take more than the dosage of Ambien or Ambien CR that is prescribed to you. You can only take one pill per night. In case you wake up in the middle of the night after taking Ambien, don’t take another one so that you can sleep again.
- Take Ambien or Ambien CR only once per night, right before bed time.
- Inform you doctor if you have drunk any amount of alcohol, used street/recreational drugs, or have overused prescription medications.
- Inform your doctor if you have been diagnosed with depression, mental illness, suicidal thoughts and self-harm, heavy snoring, sleep apnea, any breathing problems, lung diseases (asthma, bronchitis, emphysema), myasthenia gravis, or kidney or liver disease.
- Ambien may not work as intended and as effective in senior patients. Talk to your doctor if you are 65 years old or older.
- If you are pregnant, in the last term of pregnancy, planning to get pregnant, become pregnant while taking the drug, or are breastfeeding, consult your doctor about the risks of taking Ambien.
- If you are going through any form of surgery (including dental surgery), inform your doctor or dentist that you are taking Ambien.
- Alcohol worsens the side effects of Ambien. Do not consume alcohol if you are medicating with Ambien.
- Reports have been made of people who drove their cars, cooked food, had sex, made phone calls, were sleepwalking, and involved with various activities while not being fully awake. Once fully awake, these people had no recollection of what they had done. If you find this happened to you, call your doctor right away.
- Ambien may cause drowsiness, decreased mental alertness, delayed reaction time, and uncoordinated body functions the day after you take it. You may not function at your best the day after taking Ambien; machine operation and driving is strongly discouraged even if you feel fully awake.
- Your mental health and behavior may change while taking this medication. It may or may not be caused by Ambien. Inform your doctor right away if you experience aggressiveness, strange or unusually outgoing behavior, hallucinations, feeling you are outside of your body, memory problems, difficulty concentrating, anxiety, become easily agitated, slowed speech or movements, new or worsening depression, suicidal thoughts or actions, confusion, and any changes in your usual mood, thoughts, or behavior. Make sure to make your family members and caregivers know so that they can call the doctor if you are unable to seek treatment on your own.
Long-Term Use Considerations
The risks for continued use of Ambien are real and dangerous. Some of the long term considerations are:
- Dependence and addiction to the drug
- Sleepwalking, sleep-driving, and other risky behaviors while asleep
- Higher tolerance for the drug and needing larger doses
- Drug overdose
- Higher risk of negative effects if the drug is combined to other substances
- Risk of self-harm
- Memory disturbances
- Dizziness
- Drowsiness
- Headaches
Drug Interactions
Drug interactions happen when a substance that you are taking changes or disrupts a drug’s intended function. Interactions may be harmful to you, increase your risk for serious side effects, or inhibit a drug from functioning properly. Always consult a doctor if you are going to start a medication with a new drug.
Can Interact with the Following
The drugs that interact with Ambien most frequently are:
- Adderall (amphetamine/dextroamphetamine)
- Ativan (lorazepam)
- Benadryl (diphenhydramine)
- Clonazepam (klonopin, klonopin wafer)
- Cymbalta (duloxetine)
- Flexeril (cyclobenzaprine)
- Gabapentin (Neurontin, Gralise, Gaborone, Fanatrex)
- Hydrocodone (Hysingla ER, Zohydro ER, Vantrela ER)
- Klonopin (clonazepam)
- Levothyroxine (Synthroid, Levoxyl, Tirosint, Levothroid, Levothyrox, Eltroxin, Euthyrox, Unithroid, Oroxine, Eutroxsig, Levo-T, L Thyroxine Roche, Novothyrox, Levotabs, Tirosint-Sol, Levotec, Evotrox)
- Lexapro (escitalopram)
- Lisinopril (Zestril, Prinivil, Qbrelis)
- Lyrica (pregabalin)
- Melatonin (Melatonin Time Release, SGard, Bio-Melatonin, Health Aid Melatonin, VesPro Melatonin)
- Metformin (Glucophage, Glumetza, Glucophage XR, Fortamet, Riomet)
- Norco (acetaminophen/hydrocodone)
- Omeprazole (Prilosec, Prilosec OTC, Zegerid (Original Formulation), Omesec)
- Percocet (acetaminophen/oxycodone)
- Prednisone (Deltasone, Rayos, Sterapred, Prednicot, Meticorten, Sterapred DS, Liquid Pred, Orasone, Prednicen-M)
- Synthroid (levothyroxine)
- Tramadol (Ultram, Tramadol Hydrochloride ER, Tramal, ConZip, Ultram ER, Zydol, Tramahexal, Zamadol, Ryzolt, Tramal SR, Larapam SR, GenRx Tramadol, Tramahexal SR, Tramedo, Zydol XL, Rybix ODT, Ultram ODT)
- Trazodone (Desyrel, Oleptro, Desyrel Dividose)
- Tylenol (acetaminophen)
- Vicodin (acetaminophen/ hydrocodone)
- Vitamin D3 (cholecalciferol)
- Wine or any alcoholic drinks
- Zanax (alprazolam)
- Zoloft (sertraline)
Can’t Interact with the Following
Do not take Ambien if you have consumed alcohol within the day or before going to bed.
Other drugs may worsen the side effects of Ambien. Ask your doctor before using any other medications including opioids, sleeping pills, muscle relaxants, or any medicines for anxiety or seizures.
Patients with sleep apnea, myastehnia gravis, severe liver disease, respiratory depression, people with depression or psychotic illnesses, and people who have a history with addiction or substance abuse should not take this drug.
There are many drugs that should not be used together with Ambien. This may include over-the-counter medications, vitamins, supplements, and herbal products. Always ask your doctor if you wish to start or stop using any medication while you are taking this drug.
When To Stop Taking
It is advised to stop taking Ambien while traveling. It is dangerous to be awakened before the effects of the medication has fully worn off. It is common for patients to experience confusion and amnesia if the full 7-8 hours of sleep is not attained.
Stop taking the drug upon the advice of your doctor. Even if you feel that you still need to continue taking the drug, it is important to follow your doctor’s advice. Stopping the use of Ambien needs to be done slowly and safely. Stopping this medication abruptly may lead to withdrawal symptoms such as rebound insomnia, anxiety, mood swings, panic attacks, confusion, physical and psychological cravings, stomach upset, nausea and vomiting, an increased heart rate, seizures, and psychosis.
These symptoms are real health risks, it is very important that you go through a medically supervised process where the drug is slowly weaned from your system.
Long-Term Side Effects
- This medication may cause withdrawal symptoms, especially if the drug has been used regularly for an extended period of time, or in high doses. Symptoms such as nausea, vomiting, flushing, stomach cramps, shaking, and nervousness may occur if the medication is stopped suddenly. Ask your doctor for ways you can stop the medication without withdrawal symptoms.
- Prolonged use of Ambien may cause you to not feel its effects anymore. Inform your doctor if you feel Ambien has stopped working for you.
- Stopping this medication after using it for a long time may cause “rebound insomnia”. This is normal. Usually, it will go away after 1-2 nights. However, if it continues for more than two nights, inform your doctor.
United States Food and Drug Administration (FDA) Warnings
February 16, 2007: The FDA warned consumers and health care providers about the dangers of buying prescription medications online. There were instances of people who bought Ambien and other prescription drugs online, only to receive a product called haloperidol, a powerful anti-psychotic drug. Those who ingested the counterfeit drugs experienced difficulty in breathing, muscle spasms, muscle stiffness, and had to seek emergency medical help.
May 14, 2013: The FDA required a lower recommended dose for all zolpidem containing products, including Ambien. The FDA stated that bedtime doses should be lowered as new data showed that the morning after taking the medication, patients’ blood levels showed the drug was still high enough to impair activities that require full attention and alertness, including machine operation and driving. Blood level is highest in patients who used the extended-release version of the drug. Women are more likely to be affected since they eliminate the chemicals more slowly compared to men.
Because of this, the FDA urges doctors and health care professionals to warn and inform all patients who use the drug of the added risk of morning-after impairment for activities that require full attention and alertness. The recommended doses were halved and health professionals were advised to prescribe the lowest dose that treats the patient’s symptoms.
March 14, 2017: The FDA notified the manufacturers of Ambien and Ambien CR to strengthen their product labeling to include clearer warnings about the potential risks of the drug: severe allergic reaction, complex sleep-related behaviors (including doing activities such as driving while not being fully awake and not having any memory of this after waking up). The FDA also requested the manufacturers to develop Patient Medication Guides to further inform consumers about the risks and precautions in relation to the drug.
Understanding Drug Recalls
Other Common Side Effects
The following side effects are common. However, if the symptoms are severe and do not go away, call your doctor immediately:
- Drowsiness
- Tiredness
- Headache
- Dizziness
- Lightheadedness
- “Drugged feeling”
- Unsteady walking
- Ataxia (balance problems)
- Nausea
- Constipation
- Diarrhea
- Gas
- Heartburn
- Stomach pain or stomach tenderness
- Changes in appetite
- Uncontrollable shaking of a part of the body
- Pain, burning sensation, numbness, or tingling in the hands, arms, feet or legs
- Unusual dreams
- Redness, burning, or tingling of the tongue (with sublingual tablets)
- Dry mouth or throat
- Ringing, pain, or itching in the ears
- Eye redness
- Muscle aches or cramps
- Joint, back or neck pain
- Heavy menstrual bleeding
The following side effects from Ambien may be serious. Call your doctor immediately if you experience any of the following:
- Rash
- Hives
- Itching
- Swelling of the eyes, face, lips, tongue, or throat
- Feeling that the throat is closing
- Difficulty breathing or swallowing
- Hoarseness
- Shortness of breath
- Yellow eyes or skin
- Light-colored stools
- Nausea
- Vomiting
- Pounding heartbeat
- Chest pain
- Blurred vision or other vision problems
Lawsuits
Ambien has caused some serious side effects. In the last few years, the Substance Abuse and Mental Health Administration found out that hospital visits in connection with Ambien has risen to up to 220%. In 2013, a patient from Las Vegas hit a light pole but had no idea why he was behind the wheel when the accident happened. In 2014, some patients woke up in police stations after getting involved in car accidents they did not remember.
In 2009, a lawsuit was filed by a man who woke up in the middle of the night after crashing his company car. The man was initially charged with a DUI (driving under the influence). The lawsuit states that the makers of Ambien should have included sleep driving in the warning labels of the drug. Another patient filed a lawsuit against a generic version of the drug after being involved in a serious car accident while on the medication. The patient’s lawsuit states that the manufacturer of the generic brand should have properly labeled this warning on the drug packaging.
Another lawsuit stated an individual had gained a large amount of weight while under medication. The patient found out he had been sleep eating while on the drug. Today, more than 500 patients have filed lawsuits to Sanofi-Aventis for their failure to label the product with the danger of sleep eating.
Sources Cited (5)
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
