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.


Ambien Recall

Get an alert when a recall is issued.

Questions & Answers

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. (


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. (

Ambien Addiction

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

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. (

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

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. (

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. (

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. (

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. (


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. (


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. (

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:

Chemical 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.

Ambien Manufacturers

  • A-s Medication Solutions Llc
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [A-s Medication Solutions Llc]
  • Rebel Distributors Corp.
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [Rebel Distributors Corp.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Ambien (Zolpidem Tartrate) Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Stat Rx Usa Llc
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [Stat Rx Usa Llc]
  • Bryant Ranch Prepack
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [Bryant Ranch Prepack]
  • A-s Medication Solutions Llc
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [A-s Medication Solutions Llc]
  • Sanofi-aventis U.s. Llc
    Ambien (Zolpidem Tartrate) Tablet, Film Coated [Sanofi-aventis U.s. Llc]

Login To Your Free Account