Ambien

What is Ambien?

Ambien (zolpidem) is a sedative, also called a hypnotic. Zolpidem affects chemicals in the brain that may be unbalanced in people with sleep problems insomnia).

Ambien is used to treat insomnia. The immediate-release tablet is used to help you fall asleep when you first go to bed. The extended-release form, Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Your doctor will determine which form of Ambien is best for you.

Important Information

Ambien may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share Ambien with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Ambien may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take Ambien in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

Before taking this medicine

Some people using Ambien have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking this medicine and talk with your doctor about another treatment for your sleep disorder.

You should not use Ambien if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

Ambien is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • depression, mental illness, or suicidal thoughts;
  • drug or alcohol addiction;
  • lung disease or breathing problems;
  • sleep apnea (breathing stops during sleep); or
  • liver or kidney disease.

Taking Ambien in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I take Ambien?

Take Ambien exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.

The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of Ambien are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Never take this medicine if you do not have a full 7 to 8 hours to sleep before being active again.

Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take this medicine for longer than 4 or 5 weeks without your doctor’s advice.

Do not stop using Ambien suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking Ambien, and may be even worse than before. Call your doctor if you still have worsened insomnia for the first few nights after you stop taking this medicine.

Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Ambien is taken only at bedtime if needed, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while taking Ambien?

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy the morning after taking Ambien, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Ambien side effects

Zolpidem may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using this medicine and call your doctor at once if you have:

  • chest pain, fast or irregular heartbeat, feeling short of breath;
  • trouble breathing or swallowing; or
  • feeling like you might pass out.

The sedative effect of Ambien may be stronger in older adults.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common Ambien side effects may include:

  • daytime drowsiness, dizziness, weakness, feeling “drugged” or light-headed;
  • tired feeling, loss of coordination;
  • stuffy nose, dry mouth, nose or throat irritation;
  • nausea, constipation, diarrhea, upset stomach; or
  • headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ambien?

Using Ambien with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ambien only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: This document contains side effect information about zolpidem. Some of the dosage forms listed on this page may not apply to the brand name Ambien.

In Summary

Common side effects of Ambien include: dizziness. Other side effects include: hallucination. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zolpidem: spray, tablet

Other dosage forms:

  • oral spray, oral tablet, oral tablet extended release

Along with its needed effects, zolpidem (the active ingredient contained in Ambien) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zolpidem:

Less Common

  • Clumsiness or unsteadiness
  • confusion
  • depression

Rare

  • Difficulty with breathing
  • dizziness, lightheadedness, or fainting
  • falling
  • fast heartbeat
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • swelling of the face
  • trouble sleeping
  • unusual excitement, nervousness, or irritability
  • wheezing

Some side effects of zolpidem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Sleepiness or unusual drowsiness

Less Common

  • Abdominal or stomach pain
  • abnormal or decreased touch sensation
  • abnormal sensation of movement
  • appetite disorder
  • balance disorder
  • binge eating
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • change in hearing
  • chest discomfort
  • chills
  • confusion about identity, place, and time
  • constipation
  • continuous ringing, buzzing, or other unexplained noise in the ears
  • daytime drowsiness
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • difficulty with swallowing
  • discouragement
  • double vision
  • drugged feeling
  • dry mouth
  • earache
  • eye redness
  • false or unusual sense of well-being
  • feeling of unreality
  • feeling sad or empty
  • frequent bowel movements
  • frequent urge to urinate
  • headache
  • hearing loss
  • heartburn
  • hives or welts
  • itching ears
  • joint pain
  • lack of appetite
  • lack of feeling or emotion
  • lack or loss of self-control
  • lack or loss of strength
  • longer or heavier menstrual periods
  • loss of balance
  • loss of interest or pleasure
  • memory problems
  • mood swings
  • muscle aches, cramping, pain, or stiffness
  • nausea
  • nightmares or unusual dreams
  • redness of the skin
  • redness or soreness of the throat
  • sense of detachment from self or body
  • slowing of mental and physical activity
  • sneezing
  • stuffy or runny nose
  • swollen joints
  • tiredness
  • trouble concentrating
  • vision changes
  • vomiting

For Healthcare Professionals

Applies to zolpidem: oral spray, oral tablet, oral tablet extended release, sublingual tablet

General

There is evidence of a dose relationship for adverse effects, particularly for certain central nervous system and gastrointestinal events and in the elderly; in theory, these adverse effects should be less if this drug is taken immediately before bedtime.

Nervous system

Very common (10% or more): Headache (up to 19%), somnolence/drowsiness (up to 15%), dizziness (up to 12%)

Common (1% to 10%): Lethargy, lightheadedness, ataxia, vertigo, labyrinthitis, balance disorder, attention disturbance, hypoesthesia, ataxia, burning sensation, paresthesia, postural dizziness, tremor

Uncommon (0.1% to 1%): Syncope, cerebrovascular disorder, dysarthria, migraine, speech disorder, stupor, dysphagia, dysgeusia

Rare (less than 0.1%): Restless legs, rigors, abnormal gait, hypokinesia, hypotonia, neuralgia, neuritis, neuropathy, paresis, depressed level of consciousness

Cardiovascular

Common (1% to 10%): Palpitations, increased blood pressure

Uncommon (0.1% to 1%): Postural hypotension, hypertension, tachycardia, increased heart rate

Rare (less than 0.1%): Flushing, hypotension, hot flashes, angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, aggravated hypertension, myocardial infarction, phlebitis, varicose veins, ventricular tachycardia

Dermatologic

Common (1% to 10%): Rash, urticaria, skin wrinkling

Uncommon (0.1% to 1%): Increased sweating/hyperhidrosis, pruritus, contact dermatitis

Rare (less than 0.1%): Acne, bullous eruption, dermatitis, furunculosis, photosensitivity reaction, angioneurotic edema

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth, abdominal pain, constipation, dyspepsia, hiccup, nausea, vomiting, gastroenteritis, abdominal discomfort, abdominal tenderness, frequent bowel movements, gastroesophageal reflux disease, flatulence

Rare (less than 0.1%): Altered saliva, increased saliva, tenesmus, enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia, dysuria, vulvovaginal dryness

Uncommon (0.1% to 1%): Menstrual disorder, vaginitis, cystitis, urinary incontinence, dysmenorrhea

Rare (less than 0.1%): Breast fibroadenosis, breast neoplasm, breast pain, micturition frequency, nocturia, polyuria, pyelonephritis, urinary retention

Hypersensitivity

Common (1% to 10%): Allergy

Rare (less than 0.1%): Allergic reaction, aggravated allergy, anaphylactic shock

Frequency not reported: Angioedema, anaphylaxis

Metabolic

Common (1% to 10%): Appetite disorder

Uncommon (0.1% to 1%): Anorexia, hyperglycemia, thirst

Rare (less than 0.1%): Decreased weight, increased appetite, gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, myalgia, neck pain, muscle cramp

Uncommon (0.1% to 1%): Leg cramps, arthritis, muscle spasms, involuntary muscle contractions

Rare (less than 0.1%): Tetany, arthrosis, muscular weakness, sciatica, tendinitis

Ocular

Common (1% to 10%): Diplopia, abnormal vision, visual disturbance, eye redness, blurred vision, altered visual depth perception, asthenopia

Uncommon (0.1% to 1%): Eye irritation, eye pain, scleritis

Rare (less than 0.1%): Abnormal accommodation, glaucoma, periorbital edema, conjunctivitis, corneal ulceration, abnormal lacrimation, parosmia, photopsia

Other

Common (1% to 10%): Influenza-like symptoms, chest pain, chest discomfort, asthenia, fatigue, tinnitus, contusion, increased body temperature, otitis externa, pyrexia/fever, neck injury, infection

Uncommon (0.1% to 1%): Pallor, pain, edema, falling, malaise, trauma, taste perversion

Rare (less than 0.1%): Face edema, pain, increased drug tolerance, otitis media, falls, Abscess herpes simplex/herpes zoster

Frequency not reported: Injuries (e.g., hip fractures, intracranial hemorrhages)

Psychiatric

Common (1% to 10%): Depression, abnormal dreams, sleep disorder, insomnia, exacerbated/aggravated insomnia, hallucinations, agitation, nightmare, drugged feeling, confusion, euphoria, memory impairment, amnesia, anterograde amnesia, nervousness, disorientation, anxiety, psychomotor retardation, binge eating, depersonalization, disinhibition, mood swings, stress symptoms, apathy

Uncommon (0.1% to 1%): Decreased cognition, detached, difficulty concentrating, emotional lability, illusion, sleeping (after daytime dosing), irritability, drunk feeling, reduced alertness

Rare (less than 0.1%): Impotence, abnormal thinking, aggressive reaction, decreased libido, delusion, dementia, feeling strange, hysteria, intoxicated feeling, manic reaction, panic attacks, personality disorder, somnambulism, suicide attempts, neurosis, perceptual disturbances, restlessness, libido disorder, rages, inappropriate behavior

Frequency not reported: Psychoses, dependence

Postmarketing reports: Anger, abnormal behavior

Respiratory

Common (1% to 10%): Sinusitis, pharyngitis, upper respiratory infection, lower respiratory infection, throat irritation, nasopharyngitis, dry throat, rhinitis

Uncommon (0.1% to 1%): Bronchitis, coughing, dyspnea

Rare (less than 0.1%): Pulmonary embolism, pulmonary edema, yawning, bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, increased ALT/SGPT

Rare (less than 0.1%): Bilirubinemia, increased AST/SGOT

Postmarketing reports: Acute hepatocellular, cholestatic, or mixed liver injury with or without jaundice

Hematologic

Rare (less than 0.1%): Increased erythrocyte sedimentation rate (ESR), anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis

Renal

Rare (less than 0.1%): Acute renal failure, renal pain

Local

Postmarketing reports: Sublingual application site reactions (e.g., oral ulcers, blisters, mucosal inflammation)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.