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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: zolpidem (ZOLE pi dem)
Brand name(s): AMBIEN, AMBIEN CR, EDLUAR, INTERMEZZO, ZOLPIMIST
GENERIC: available FAMILY: Other Sleeping Pills and Tranquilizers
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

This drug caused harm to developing fetuses in animal studies, including incomplete formation of the bones in the back and skull as well as fetal death. Children born of mothers who took sedative/hypnotic drugs are at some risk for withdrawal symptoms as well as lacking muscle strength. Use during pregnancy only if clearly needed. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

Breast-feeding Warning

Zolpidem inhibits milk secretion and is secreted into milk. It should not be used by nursing mothers.

Safety Warnings For This Drug [top]

FDA-REQUIRED BLACK-BOX WARNING

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem. Some of these events may result in serious injuries, including death. Discontinue zolpidem immediately if the patient experiences a complex sleep behavior.

If you are currently taking zolpidem and develop complex sleep behaviors, discontinue the drug immediately and seek medical help.

Otherwise, if you have been taking zolpidem for awhile, do not stop taking this drug suddenly because it may cause drug-induced dependence. Instead, work with your doctor to create a schedule to stop it gradually to avoid withdrawal reactions (including stomach cramps, vomiting, nervousness and panic attacks).

The best way to reduce the risks from sleeping pills and tranquilizers is to avoid them if at all possible. Before taking one of these powerful medications, see the Sleeping Pills and Tranquilizers section of this site for nondrug alternatives to try before using either sleeping pills or tranquilizers.

Facts About This Drug [top]

Zolpidem (AMBIEN, AMBIEN CR, EDLUAR, INTERMEZZO, ZOLPIMIST) is approved by the Food and Drug Administration (FDA) for short-term relief of insomnia. We designated this drug as Do Not Use because its risks far outweigh its benefits.

Zolpidem belongs to the family of drugs known as non-benzodiazepine sleeping pills, which also includes the other two of the three so-called “Z drugs”: zaleplon (SONATA) and eszopiclone (LUNESTA). These three drugs all work in a way that is similar to the...

Zolpidem (AMBIEN, AMBIEN CR, EDLUAR, INTERMEZZO, ZOLPIMIST) is approved by the Food and Drug Administration (FDA) for short-term relief of insomnia. We designated this drug as Do Not Use because its risks far outweigh its benefits.

Zolpidem belongs to the family of drugs known as non-benzodiazepine sleeping pills, which also includes the other two of the three so-called “Z drugs”: zaleplon (SONATA) and eszopiclone (LUNESTA). These three drugs all work in a way that is similar to the sleeping pills and tranquilizers called benzodiazepines (an older family of drugs that includes diazepam [VALIUM]), but they have a different chemical structure. Although zolpidem is not a benzodiazepine, it shares many similarities with that family of drugs.[1] Like the benzodiazepine drug family, zolpidem can cause drowsiness. Also, it can be habit-forming, so zolpidem is a controlled substance.

Patients should keep in mind that nondrug treatment is the best option for the management of insomnia.

Adverse effects

In a 2004 review of zolpidem, zaleplon and zopiclone (an old drug that contains eszopiclone), the National Institute for Health and Clinical Excellence in Britain concluded the following::

There have been multiple reports of sleepwalking (inappropriate or strange automatic behavior while asleep, including binge eating and house painting) recorded in patients using zolpidem during the first year the drug was on the market.[2]

In 2019, the FDA required that a black-box warning be added to the product labeling for zolpidem about complex sleep behaviors, including sleepwalking, sleep driving and engaging in other activities while not fully awake, that are associated with use of the drug. The warning notes that these events may result in serious injury or death and that the drug should be discontinued immediately if a patient experiences such sleep behaviors.[3]

A February 2007 Australian Adverse Drug Reactions Bulletin also found 16 reports of sleepwalking in patients using zolpidem during the first year the drug was on the market.

The effects of zolpidem on balance and cognition after awaking from sleep were evaluated in a randomized, placebo-controlled trial where patients were administered either zolpidem or a placebo prior to sleep. The study found that patients who received zolpidem were at a higher risk of balance and cognition impairment, including instability when walking, which is especially concerning for elderly patients at risk of falls and fractures.[4] In fact, the drug has been shown to increase the risk of hip fractures in elderly patients.[5]

The FDA also wants the professional product labels of certain sleeping pills to warn users about anaphylaxis, a severe and life-threatening allergic reaction, and angioedema, severe facial swelling that can occur the first time a sleeping pill is taken.[6]

In June 2012, Australia’s Medicine Safety Update reported that it continues to receive reports of sleep-related adverse effects and amnesia associated with zolpidem use. The agency urges prescribers and patients to be cautious when using this drug.[7]

The Drug Abuse Warning Network reported that in 2010, 19,487 emergency room visits involved the use of zolpidem. This was three times more emergency visits than were associated with zolpidem in 2005. About two-thirds of the patients were women, and almost three-quarters were 45 or older (with those 65 or older accounting for one-third of all visits).[8] Another study, published in JAMA Psychiatry in September 2014, found that from 2009 through 2011, zolpidem was the drug most frequently linked to emergency department visits for psychiatric drug-induced adverse drug reactions.[9] Nearly a quarter of these visits resulted in hospitalization.

Studies show...

One meta-analysis compared the effectiveness of drug treatment with that of behavioral therapy in the management of persistent insomnia. The authors of the study concluded the following: “Overall, behavior therapy and pharmacotherapy produce similar short-term treatment outcomes in primary insomnia.”[10]

A March 2014 study in the United Kingdom found an increase in the risk of death in people using tranquilizers or sleeping pills. The results were similar to those from a 2012 study. Concerns about the effect of these drugs on premature mortality have been fueled by studies documenting increased risk of dementia, daytime fatigue, lack of coordination, falls, road traffic incidents, and pneumonia and other infections.[11]

In 2015, a study published by the Mayo Clinic showed that zolpidem use was associated with an increased risk of suicide or attempted suicide.[12]

Regulatory actions surrounding zolpidem

2006: In December, the FDA requested that sleeping pill manufacturers include information about risks such as anaphylaxis, angioedema and complex sleep-related behaviors (e.g., driving, making phone calls and preparing and eating food while asleep) on their product labels.[13]

2007: The FDA warned that hallucinations were reported in 7.4% of pediatric patients taking zolpidem. None of the pediatric patients receiving a placebo reported hallucinations.[14]

In March, the FDA asked manufacturers of sedative hypnotic drugs, such as zolpidem, to update the drug product labels concerning potential risks associated with use of these medications, including “severe allergic reactions and complex sleep-related behaviors.” Allergic reactions included anaphylaxis and angioedema. Complex sleep-related behaviors included sleep-driving, making phone calls and preparing and eating food while asleep.

The following medications were specifically mentioned in the FDA advisory:

  • zolpidem (AMBIEN/AMBIEN CR — Sanofi Aventis)
  • butabarbital (BUTISOL SODIUM — Medpointe Pharmaceuticals HLC)
  • pentobarbital and carbromal (CARBRITAL — Parke-Davis)
  • flurazepam (DALMANE — Valeant Pharmaceuticals)
  • quazepam (DORAL — Questcor Pharmaceuticals)
  • triazolam (HALCION — Pharmacia & Upjohn)
  • eszopiclone (LUNESTA — Sepracor)
  • ethchlorvynol (PLACIDYL — Abbott)
  • estazolam (PROSOM — Abbott)
  • temazepam (RESTORIL — Tyco Healthcare)
  • ramelteon (ROZEREM — Takeda Pharmaceutical)
  • secobarbital (SECONAL — Eli Lilly)
  • zaleplon (SONATA — King Pharmaceuticals)[15]

The FDA also requested that Medication Guides be developed for consumers. Click here to see the Medication Guide for zolpidem.

2010: In April, the FDA updated the product label of zolpidem to state that there have been reported cases of severe neonatal respiratory depression when zolpidem was used at the end of pregnancy. These cases were more common when zolpidem was taken with other central nervous system depressants.[16]

2013: In January, the FDA issued an advisory concerning the dosage of zolpidem related to impairment of activities requiring alertness the next day. The FDA recommended a decreased bedtime dose of zolpidem based on new data showing that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

According to the advisory, the data showed the risk of next-morning impairment to be the highest for women and anyone taking an extended-release formulation. Women appear to be more susceptible to the risk of next-morning impairment because they eliminate zolpidem from their bodies more slowly than men do.

Because lower doses of zolpidem will result in lower levels of the drug in the blood the next morning, the FDA is requiring manufacturers to lower the recommended dose.[17]

2016: In December, the FDA updated the product label of zolpidem to warn that patients with liver disease who use the drug have an increased risk of hepatic encephalopathy, a condition in which the liver is not able to remove poisonous substances from the body. Those substances can build up and interfere with brain function, leading to confusion and even coma.[18]

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  • Acute alcohol intoxication  with depressed vital signs
  • History of alcohol or drug abuse or dependence
  • Impaired liver function
  • Mental depression
  • Severe chronic obstructive lung disease
  • Impaired kidney function
  • Allergy to zolpidem
  • Known or suspected sleep apnea
  • Pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Avoid use of alcohol or other central nervous system depressants
  • Clumsiness or unsteadiness, drowsiness, dizziness, or visual disturbances can occur, especially in the elderly
  • Changes in behavior or thinking can occur, such as more outgoing or aggressive behavior than normal; loss of personal identity; confusion; strange behavior; agitation; hallucinations; worsening of depression; or suicidal thoughts
  • Amnesia can occur; to avoid this, only take zolpidem when able to get a full night’s sleep (7-8 hours) before the need to be active again
  • Check with your doctor before discontinuing zolpidem if you have taken more than 1-2 weeks; gradual dosage reduction may be necessary to avoid withdrawal symptoms

How to Use This Drug [top]

  • Do not take more than the amount prescribed, because of habit-forming potential
  • Do not increase dose if zolpidem becomes less effective over time; check with your doctor
  • Be prepared to go to sleep immediately after taking zolpidem
  • Skip a missed dose.   Do not take double doses.
  • Do not share your medication with others
  • Take the drug at the same time each day
  • Store tablets at room temperature with lid on tightly.  Do not store in the bathroom.  Do not expose to heat, moisture, or strong light.  Keep out of reach of children.
  • Take on an empty stomach for the most rapid effect

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

Central nervous system (CNS) depressant drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.

Another interacting drug is: rifampin (RIFADIN).

Adverse Effects [top]

Call your doctor immediately if you experience:

  •   wheezing or difficulty breathing
  •   irregular or fast heartbeat
  •   clumsiness or unsteadiness
  •   swelling of face
  •   rash
  •   confusion
  •   dizziness, lightheadedness, or fainting
  •   falling
  •   depression
  •   unusual excitement, nervousness, or irritability
  •   hallucinations
  •   insomnia

Call your doctor if these symptoms continue:

  •   abnormal dreams, nightmares
  •   memory problems
  •   dizziness
  •   lightheadedness
  •   abdominal pain
  •   dry mouth
  •   back pain or muscle aches
  •   nausea or vomiting
  •   diarrhea
  •   drowsiness during the day
  •   drugged feelings
  •   general feeling of discomfort
  •   headache
  •   sleepwalking[19]
  •   problems with vision, including double vision

Call your doctor if these symptoms continue after you stop taking the drug:

  •   abdominal or stomach cramps
  •   agitation, nervousness, or feelings of panic
  •   flushing
  •   lightheadedness
  •   muscle cramps
  •   nausea or vomiting
  •   worsening of mental or emotional problems
  •   seizures
  •   sweating, tremors
  •   unusual tiredness or weakness
  •   uncontrolled crying

Signs of overdose:

  •   severe unsteadiness
  •   slow heartbeat
  •   double vision
  •   severe dizziness
  •   severe drowsiness
  •   severe nausea
  •   trouble breathing
  •   unconsciousness
  •   severe vomiting

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

last reviewed January 31, 2021