Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Ambien
  2. Ambien CR

Descriptions


Zolpidem is used to treat insomnia (sleeping problems). It belongs to the group of medicines called central nervous system (CNS) depressants. These medicines will slow down the nervous system. Zolpidem will help you get to sleep faster and sleep through the night. In most cases, sleep medicines should only be used for short periods of time, such as 1 or 2 days, and for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet, Extended Release
  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of zolpidem in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolpidem in the elderly. However, confusion, dizziness, and falling are more likely to occur in the elderly, who are more sensitive than younger adults to the effects of zolpidem.

Pregnancy

Information about this zolpidem-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Sodium Oxybate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Carbamazepine
  • Carbinoxamine
  • Ceritinib
  • Chlordiazepoxide
  • Chlorpromazine
  • Clarithromycin
  • Clonazepam
  • Clorazepate
  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Dexmedetomidine
  • Diazepam
  • Diphenhydramine
  • Doxylamine
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Fentanyl
  • Flurazepam
  • Fospropofol
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Lorazepam
  • Meclizine
  • Meprobamate
  • Midazolam
  • Mitotane
  • Morphine
  • Morphine Sulfate Liposome
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Piperaquine
  • Prazepam
  • Primidone
  • Promethazine
  • Propofol
  • Quazepam
  • Ramelteon
  • Secobarbital
  • Siltuximab
  • Tapentadol
  • Temazepam
  • Thioridazine
  • Triazolam
  • Zaleplon

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion
  • Ciprofloxacin
  • Desipramine
  • Fluvoxamine
  • Ketoconazole
  • Perampanel
  • Rifampin
  • Sertraline
  • St John's Wort
  • Telaprevir
  • Venlafaxine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Drug abuse or dependence, history of—Dependence on zolpidem may develop.
  • Depression, history of or
  • Lung disease or other breathing problems or
  • Mental illness, history of or
  • Myasthenia gravis (muscle disease) or
  • Sleep apnea (breathing problems during sleep)—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. Higher blood levels of zolpidem may result, increasing the chance of side effects.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take zolpidem just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

Swallow the extended-release tablet whole. Do not divide, crush, or chew it.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Zolpidem should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of insomnia:
    • For oral dosage form (extended-release tablets):
      • Adults—6.25 milligrams (mg) (for women) or 6.25 or 12.5 mg (for men) once a day at bedtime. Your doctor may increase your dose as needed. However, do not take more than 12.5 mg per day.
      • Older adults—6.25 mg once a day at bedtime.
      • Children—Use and dose must be determined by the doctor.
    • For oral dosage form (tablets):
      • Adults—5 milligrams (mg) for women and 5 or 10 mg for men once a day at bedtime. Your doctor may increase your dose as needed. However, do not take more than 10 mg per day.
      • Older adults—5 mg once a day at bedtime.
      • Children—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use this medicine only when you cannot sleep. You do not need to keep a schedule for taking it.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Zolpidem may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a rash, itching, hives, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert or not able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that this has happened.

Do not change your dose or stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine 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:

Less common

  1. Chest pain
  2. confusion
  3. confusion about identity, place, and time
  4. discouragement
  5. false or unusual sense of well-being
  6. fast, irregular, pounding, or racing heartbeat or pulse
  7. feeling sad or empty
  8. fever
  9. general feeling of discomfort or illness
  10. irritability
  11. lack of appetite
  12. lightheadedness
  13. loss of interest or pleasure
  14. shakiness and unsteady walk
  15. tiredness
  16. trouble concentrating
  17. trouble sleeping
  18. unsteadiness, trembling, or other problems with muscle control or coordination
  19. unusual tiredness or weakness

Less common or rare

  1. Anxiety
  2. bladder pain
  3. bloody or cloudy urine
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. chills
  6. cold sweats
  7. crying
  8. decreased awareness or responsiveness
  9. depersonalization
  10. difficult, burning, or painful urination
  11. dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  12. dry mouth
  13. dysphoria
  14. euphoria
  15. fainting
  16. frequent urge to urinate
  17. hyperventilation
  18. irregular heartbeats
  19. irritability
  20. lower back or side pain
  21. paranoia
  22. quick to react or overreact emotionally
  23. rapidly changing moods
  24. restlessness
  25. seeing, hearing, or feeling things that are not there
  26. severe sleepiness
  27. shakiness in the legs, arms, hands, or feet
  28. shortness of breath
  29. trembling or shaking of the hands or feet

Rare

  1. Attack, assault, or force
  2. black, tarry stools
  3. change in walking and balance
  4. clumsiness or unsteadiness
  5. cough
  6. delusions
  7. dementia
  8. difficulty swallowing
  9. dizziness
  10. hives
  11. itching
  12. lack of feeling or emotion
  13. pale skin
  14. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  15. skin rash
  16. sore throat
  17. sores, ulcers, or white spots on the lips or in the mouth
  18. swollen glands
  19. thoughts of killing oneself or changes in behavior
  20. tightness in the chest
  21. troubled breathing with exertion
  22. uncaring
  23. unusual bleeding or bruising

Some side effects 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

  1. Drowsiness
  2. headache
  3. muscle aches
  4. sleepiness or unusual drowsiness
  5. stuffy or runny nose

Less common

  1. Abdominal or stomach discomfort
  2. acid or sour stomach
  3. back pain
  4. being forgetful
  5. belching
  6. body aches or pain
  7. congestion
  8. diarrhea
  9. difficulty having a bowel movement (stool)
  10. difficulty with moving
  11. double vision
  12. feeling of constant movement of self or surroundings
  13. heartburn
  14. hoarseness
  15. indigestion
  16. longer or heavier menstrual periods
  17. loss of memory
  18. muscle pain or stiffness
  19. nausea
  20. pain or tenderness around the eyes and cheekbones
  21. seeing double
  22. sensation of spinning
  23. tender, swollen glands in the neck
  24. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  25. voice changes

Less common or rare

  1. Bad, unusual, or unpleasant (after) taste
  2. breast pain
  3. change in taste
  4. changes in patterns and rhythms of speech
  5. increased sweating
  6. itching of the vagina or genital area
  7. pain during sexual intercourse
  8. paleness of the skin
  9. slurred speech
  10. thick, white vaginal discharge with no odor or with a mild odor
  11. vomiting

Rare

  1. Blemishes on the skin
  2. blindness
  3. blurred vision
  4. change in near or distance vision
  5. decreased interest in sexual intercourse
  6. difficulty in focusing eyes
  7. eye pain
  8. feeling of warmth
  9. frequent urge to defecate
  10. inability to have or keep an erection
  11. increased appetite
  12. increased sensitivity of the skin to sunlight
  13. lack or loss of strength
  14. loss in sexual ability, desire, drive, or performance
  15. pimples
  16. redness of the face, neck, arms, and occasionally, upper chest
  17. redness or other discoloration of the skin
  18. severe sunburn
  19. stomach upset
  20. straining while passing stool
  21. tearing
  22. weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.