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 the brand name for zolpidem, a drug that’s used to treat insomnia. Insomnia is a sleep disorder that makes it difficult for you to go to sleep, stay asleep, or both.

Ambien is in a class of drugs called sedative-hypnotics. They work by slowing the activity in your brain, which allows for a state of sleep. Sanofi-Aventis makes Ambien, which was approved by the Food and Drug Administration (FDA) in 1992. Several companies make generic zolpidem, which became available in 2007.

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.

In addition to Ambien, zolpidem is available as:

• Edluar, a sublingual tablet (placed under your tongue)
• Zolpimist, an oral spray
• Intermezzo, a rapid-acting sublingual tablet
• Ambien CR, an extended release tablet with one layer to help you go to sleep and another to help you stay asleep

Important information

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.

Zolpidem 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 this medication 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.

Some people using this medicine 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 Ambien and talk with your doctor about another treatment for your sleep disorder.

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

Zolpidem may be habit forming. Keep the medication in a place where others cannot get to it.

Uses

Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night’s rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.

This medication is usually limited to short treatment periods of 1 to 2 weeks or less.

How to use Ambien

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Ambien Side Effects

Seek emergency medical help right away if you have any of these signs of an allergic reaction to Ambien:

• Hives
• Trouble breathing
• Swelling of your tongue, throat, or face
• Nausea
• Vomiting

Serious side effects of Ambien are:

• Getting out of bed while not being fully awake and performing an activity that you are not aware you are doing, such driving a vehicle, sleep-walking, preparing and eating food, making phone calls, or having sex
• Abnormal thoughts or behaviors, such as aggressiveness, abnormal extroversion, confusion, agitation, hallucinations, worsening of depression, or suicidal thoughts or actions
• Memory loss
• Anxiety
• Sleepiness during the day

Common side effects of Ambien are:

• Drowsiness
• Tiredness
• Sleepiness during the day
• Dizziness
• Drugged feelings
• Nausea
• Diarrhea
• Headache

Call your doctor if you experience any of the following mouth side effects after taking Edluar (zolpidem sublingual tablets):

• Tender red bumps under the tongue
• Tingling, tickling, prickling, pricking, or burning of the tongue

Call your doctor if you experience of these, or any other side effects, particularly if they are severe or do not go away.

Drowsiness and impairment from zolpidem may be worse in the elderly or people who are debilitated.

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.

Less Common

• Chest pain
• confusion
• confusion about identity, place, and time
• discouragement
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling sad or empty
• fever
• general feeling of discomfort or illness
• irritability
• lack of appetite
• lightheadedness
• loss of interest or pleasure
• shakiness and unsteady walk
• tiredness
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

Less Common or Rare

• Anxiety
• bladder pain
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chills
• cold sweats
• crying
• decreased awareness or responsiveness
• depersonalization
• difficult, burning, or painful urination
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• dry mouth
• dysphoria
• euphoria
• fainting
• frequent urge to urinate
• hyperventilation
• irregular heartbeats
• irritability
• lower back or side pain
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• seeing, hearing, or feeling things that are not there
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• trembling or shaking of the hands or feet

Rare

• Attack, assault, or force
• black, tarry stools
• change in walking and balance
• clumsiness or unsteadiness
• cough
• delusions
• dementia
• difficulty swallowing
• dizziness
• hives, itching, or skin rash
• lack of feeling or emotion
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• thoughts of killing oneself or changes in behavior
• tightness in the chest
• troubled breathing with exertion
• uncaring
• unusual bleeding or bruising

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

• Drowsiness
• headache
• muscle aches
• sleepiness or unusual drowsiness
• stuffy or runny nose

Less common

• Abdominal or stomach discomfort
• acid or sour stomach
• back pain
• being forgetful
• belching
• body aches or pain
• congestion
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• double vision
• feeling of constant movement of self or surroundings
• heartburn
• hoarseness
• indigestion
• longer or heavier menstrual periods
• loss of memory
• muscle pain or stiffness
• nausea
• pain or tenderness around the eyes and cheekbones
• seeing double
• sensation of spinning
• tender, swollen glands in the neck
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• voice changes

Less common or rare

• Bad, unusual, or unpleasant (after) taste
• breast pain
• change in taste
• changes in patterns and rhythms of speech
• increased sweating
• itching of the vagina or genital area
• pain during sexual intercourse
• paleness of the skin
• slurred speech
• thick, white vaginal discharge with no odor or with a mild odor
• vomiting

Rare

• Blemishes on the skin
• blindness
• blurred vision
• change in near or distance vision
• decreased interest in sexual intercourse
• difficulty in focusing eyes
• eye pain
• feeling of warmth
• frequent urge to defecate
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the skin to sunlight
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• pimples
• redness of the face, neck, arms, and occasionally, upper chest
• redness or other discoloration of the skin
• severe sunburn
• stomach upset
• straining while passing stool
• tearing
• weight loss

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

A product that may interact with this drug is: sodium oxybate.

Other medications can affect the removal of zolpidem from your body, which may affect how zolpidem works. Examples include azole antifungals (such as ketoconazole), rifampin, St. John’s Wort, among others.

Ambien Dosage

Ambien and other forms of zolpidem should be taken exactly as prescribed by your doctor.

Tablets are available in strengths of 5 mg and 10 mg.

Extended release tablets are available in strengths of 6.25 mg and 12.5 mg.

If you have taken Ambien before, your doctor may now prescribe a lower dose, because the FDA lowered the recommended dose in 2013.

New information shows that levels of the drug in some patients may be high enough to cause impaired activities, especially those that require alertness, the morning after using Ambien.

The recommend Ambien dose is lower in women than men.

Here are some general rules for taking Ambien:

• Swallow Ambien tablets whole; do not crush, divide, or chew them.
• Do not take with or right after a meal.
• Take right before you get into bed and only when you are able to stay in bed for an entire night (7 to 8 hours) before being active again.
• Within 7 to 8 hours of taking Ambien, do not perform activities that require mental alertness or coordination.

Zolpidem sublingual tablets (Edluar) are available in strengths of 5 mg and 10 mg.

Place the sublingual tablet under the tongue, where it will disintegrate. Do not swallow the tablet or take it with water.

Zolpidem oral spray (Zolpimist) is available as a cherry-flavored spray solution in a container. Each spray delivers 5 mg of zolpidem.

Zolpidem rapid-acting sublingual tablets (Intermezzo) are available in strengths of 1.75 mg and 3.5 mg.

Take the rapid-acting sublingual tablet in bed when you wake up in the middle of the night and have difficulty going back asleep.

While in bed, place the tablet under your tongue and allow it to break apart completely. Do not swallow it whole.

Precautions

Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of sleepwalking, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).

How it works

• Ambien is a brand (trade) name for zolpidem.
• Zolpidem causes sedative effects by enhancing the effects of GABA, a chemical transmitter in the brain. However, zolpidem’s chemical structure is different from benzodiazepines.
• Ambien belongs to the class of medicines known as sedative-hypnotics. It may also be called a Z-drug.

Upsides

• May be used for the short-term relief of insomnia.
• Ambien is available as an immediate-release tablet to help people who have trouble falling asleep and in an extended-release form, called Ambien CR, which has two layers. The first layer dissolves quickly to help people fall asleep, and the second layer dissolves slowly to help people to stay asleep.
• Ambien is available as a generic under the name zolpidem.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Drowsiness and unsteadiness on standing leading to an increased risk of falls, a drugged feeling, lightheadedness, and a headache, are the most commonly reported side effects.
• Ambien is intended as a sleep aid. People should not drive or operate machinery after taking Ambien. Alcohol can exacerbate the effects of Ambien and should be avoided.
• Only take Ambien or Ambien CR if you intend to stay in bed a full night (7 to 8 hours).
• Ambien can be habit-forming. Only take as recommended by your doctor and for the shortest time possible. Never share with another person and keep medication out of reach of children or others who may misuse it. Selling or giving away this medicine is against the law. May not be suitable for people with a history of substance abuse or addictive disorders. Keep legitimate supplies of Ambien out of sight of potential drug seekers.
• There have been reports of withdrawal symptoms occurring on abrupt discontinuation of Ambien. Symptoms may include low mood, insomnia, tremor, abdominal and muscle cramps, vomiting, sweating, and rarely seizures. Ambien should be tapered off slowly on discontinuation.
• Reports of “sleep-driving” (driving while not fully awake), and other behaviors (eg, eating, making phone calls, having sex) after Ambien ingestion are documented. The risk may be exacerbated by large doses or alcohol. Seek medical advice if this occurs.
• May interact with several other medicines, including other drugs that have sedation as a side effect. See prescribing information for a full list of interactions.
• May not be suitable for some people including those with respiratory disease, kidney or liver disease, psychiatric illness, or those with a history of substance abuse or addictive disorders.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Bottom Line

• Ambien induces sleep; however, Ambien CR may impair physical and mental capabilities the next day. Ambien has been associated with complex or dangerous sleep-related behaviors like “sleep-driving” which is worse with high doses or when combined with alcohol or other drugs that cause sleepiness.

Tips

• Food delays the speed of Ambien’s effect. Ambien will work faster if not taken with food.
• Take tablets immediately before going to bed, not sooner. Do not take Ambien if you have drunk alcohol that evening or before bed. Do not take Ambien if you are unlikely to stay in bed for the next seven to eight hours.
• Ambien CR may help you to stay asleep, as well as promoting sleep initiation. Do not cut, crush, or chew this formulation. Take only as directed by your doctor. Do not increase the dosage without your doctor’s advice.
• Higher dosages and CR formulation may impair next-day alertness and your ability to drive. Do not drive or perform other hazardous tasks if you still feel sleepy the next day.
• Ambien should not be given to children because its safety and effectiveness in children have not been demonstrated.
• Tell your doctor if your sleep worsens after taking Ambien.
• Only use Ambien for short periods of time to help with sleep (ideally no more than seven to ten days) as it can be habit-forming. Sleep disturbance can be a sign of some other underlying disorder. Call your doctor if your insomnia worsens or does not improve within seven to ten days.
• Ambien can increase your risk of falls, particularly if you need to get up in the middle of the night to go to the toilet. Remove any fall hazards from your house (such as loose rugs) and slowly get out of bed when getting up in the middle of the night.
• Seek immediate medical advice if you experience any unusual side effects from Ambien such as worsening of insomnia, aggressiveness, hallucinations, or bizarre behaviors.
• Talk to your doctor or pharmacist before buying other medications over the counter to check that they are compatible with Ambien.

Response and Effectiveness

• The time to Ambien’s peak effect varies depending on whether the Ambien is immediate or controlled release (CR) but ranges from just over half an hour to 1.5 hours. Food delays the time Ambien takes to reach peak levels.
• Ambien CR has two layers: the first dissolves quickly to help you fall asleep, and the second layer dissolves slowly to help you stay asleep.

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