Zolpidem Tartrate
Zolpidem Tartrate · Say it: zol-PI-dem TAR-trate
A prescription sleep medicine taken by mouth at bedtime for the short-term treatment of trouble falling asleep. This summary is based on the zolpidem tartrate tablet label.
Brand names: Ambien CR
⬛ Boxed warning (the FDA's strongest warning)
The boxed warning is about complex sleep behaviors. These include sleep-walking, sleep-driving, and doing other activities while not fully awake, such as making and eating food, making phone calls, or having sex. Some of these events have resulted in serious injuries, including death. The label says to stop the medicine immediately if a complex sleep behavior happens.
Used for
The label says it is used for the short-term treatment of insomnia (trouble falling asleep, which the label calls difficulty with sleep initiation) in adults. The label says it is not recommended for children under 18.
Comes as
5 mg tablets: pink, round, film coated, debossed "IT 117" on one side (not scored); 10 mg tablets: white, round, film coated, debossed "IT 118" on one side (not scored)
Common side effects
Short-term use (under about 10 nights): drowsiness, dizziness, and diarrhea, Longer-term use (about 28 to 35 nights): dizziness and drugged feelings, Daytime drowsiness, headache, and nausea were among the reactions that most often led people to stop treatment in clinical trials
| Generic name | Zolpidem Tartrate |
|---|---|
| Brand names | Ambien CR |
| Type of medicine | a sleep medicine of the imidazopyridine class. The label describes it as a GABA A receptor positive modulator. |
| How it is sold | Prescription sleep medicine (oral tablet, federally controlled substance C-IV) |
| Comes as | 5 mg tablets: pink, round, film coated, debossed "IT 117" on one side (not scored); 10 mg tablets: white, round, film coated, debossed "IT 118" on one side (not scored) |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2025-05-22 |
💊 What is Zolpidem Tartrate used for?
- The label says it is used for the short-term treatment of insomnia (trouble falling asleep, which the label calls difficulty with sleep initiation) in adults. The label says it is not recommended for children under 18.
How it works
The label describes zolpidem as a GABA A receptor positive modulator, a type of medicine that acts on certain receptors in the brain to help with sleep.
How it is usually taken
- The label says to take a single tablet at night, right before bedtime, and not to take a second dose during the same night. Take it exactly as prescribed and do not change the dose on your own. Do not take it with or right after a meal, because food may slow its effect. The label says it may help you fall asleep faster on an empty stomach. Only take it if you can stay in bed a full night (7 to 8 hours) before you must be active again. The label says it is for short-term use only, and long-term use is not recommended. Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days.
Comes as
- 5 mg tablets: pink, round, film coated, debossed "IT 117" on one side (not scored)
- 10 mg tablets: white, round, film coated, debossed "IT 118" on one side (not scored)
⚠️ Zolpidem Tartrate side effects
Common side effects
- Short-term use (under about 10 nights): drowsiness, dizziness, and diarrhea
- Longer-term use (about 28 to 35 nights): dizziness and drugged feelings
- Daytime drowsiness, headache, and nausea were among the reactions that most often led people to stop treatment in clinical trials
Get medical help right away if
- Get medical help right away if you do any activity while not fully awake, such as sleep-walking, sleep-driving, making and eating food, talking on the phone, or having sex. The label says to stop the medicine and call your healthcare provider right away.
- Get medical help right away if you have signs of a severe allergic reaction, such as angioedema or anaphylaxis. The label says these reactions have been reported and that the medicine should not be given again if they occur.
- Get medical help right away if you have new behavior changes, such as decreased inhibition, bizarre behavior, agitation, or feeling detached from yourself (depersonalization). The label says these should be evaluated immediately.
- Get medical help right away if depression gets worse or you have suicidal thoughts.
- Get medical help right away if you have breathing problems (respiratory depression), especially if you also take opioids or other sleep-causing medicines.
- Tell your healthcare provider if you have withdrawal symptoms, which the label says may occur with a rapid dose reduction or stopping the medicine.
🛑 Who should not take Zolpidem Tartrate, and who should be careful
The label says not to take it if
- You have had complex sleep behaviors after taking zolpidem in the past.
- You are allergic to zolpidem or any of the ingredients in the tablets.
- You are not able to stay in bed for a full night (7 to 8 hours) before you must be active again.
- You drank alcohol that evening or before bed.
Tell your doctor before taking it if
- Tell your healthcare provider about any history of depression, mental illness, or suicidal thoughts or actions.
- Tell your provider about any history of drug or alcohol abuse or addiction.
- Tell your provider if you have kidney or liver disease, a lung disease or breathing problems, sleep apnea, or myasthenia gravis.
- Tell your provider if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.
- Tell your provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- The label says the medicine can make you sleepy or dizzy, so do not drive or operate heavy machinery until you know how it affects you.
🔀 Zolpidem Tartrate with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Alcohol and other CNS depressants: may increase drowsiness, slowed thinking, and impaired driving ability.
- Benzodiazepines and other sleep medicines (including other zolpidem products): the label says use with these is not recommended at bedtime or in the middle of the night, and combined use can increase CNS depression.
- Opioids: may increase the risk of breathing problems (respiratory depression). The label says to limit dosage and duration of combined use.
- Tricyclic antidepressants, imipramine, and chlorpromazine: may add to decreased alertness and impaired psychomotor performance.
- Sertraline: increases the amount of zolpidem in the body.
- Fluoxetine: increased the half-life of zolpidem by 17% in a study, with no evidence of an additive effect on psychomotor performance.
- Rifampin or St. John's wort: may decrease the effect of zolpidem.
- Ketoconazole: may increase the effect of zolpidem.
- Haloperidol: a study showed no effect of haloperidol on zolpidem in single-dose use. The label notes that single-dose results do not predict the effect of long-term use.
- Ask your pharmacist for a list of medicines that interact with zolpidem.
Alcohol and food
The label says not to take zolpidem with or right after a meal. It also says not to take it if you drank alcohol that evening or before bed. Alcohol can add to its effects on alertness and psychomotor performance.
🤰 Zolpidem Tartrate in pregnancy and breastfeeding
Pregnancy
The label says taking zolpidem in the third trimester of pregnancy may harm an unborn baby. Babies born to mothers who took it late in pregnancy may have breathing problems and sedation, such as sleepiness or low muscle tone. Published observational data have not shown a clear link between zolpidem and major birth defects. Tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment.
Breastfeeding
The label says zolpidem passes into breast milk and may harm a baby. Talk to your healthcare provider about the best way to feed your baby during treatment.
🗓️ Storage, missed doses and taking too much
Storage
The label says to store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Because zolpidem is a federally controlled substance (C-IV), the label says to keep it in a safe place to protect it from theft. The label also says never to give it to anyone else, because it may cause death or harm them, and that selling or giving it away is against the law.
If a dose is missed
The label does not say.
If too much is taken
The label says that overdose with zolpidem, alone or with other CNS-depressant medicines, has caused impaired consciousness ranging from sleepiness to coma, cardiovascular and/or respiratory problems, and deaths. If you take too much, the label says to call your healthcare provider or go to the nearest hospital emergency room right away.
🗒️ Questions to ask about Zolpidem Tartrate
🎯 Check what you understood
1. According to the summary, when is zolpidem taken?
2. What does the boxed warning say to do if a complex sleep behavior happens?
3. What does the label say about how long zolpidem should be used?
❓ Zolpidem Tartrate: frequently asked questions
What is zolpidem used for?
The label says zolpidem is used for the short-term treatment of trouble falling asleep (insomnia) in adults. It is not recommended for children under 18.
Can I drink alcohol while taking zolpidem?
The label says not to take zolpidem if you drank alcohol that evening or before bed. It also says alcohol has an additive effect on psychomotor performance.
Can I take zolpidem with food?
The label says you should not take zolpidem with or right after a meal. It may help you fall asleep faster if taken on an empty stomach.
Is zolpidem safe during pregnancy?
The label says taking zolpidem in the third trimester may harm an unborn baby and can cause breathing problems and sedation in newborns. Tell your healthcare provider right away if you are pregnant or plan to become pregnant.
What should I do if I think I took too much?
The label says to call your healthcare provider or go to the nearest hospital emergency room right away. Overdose has been reported to cause impaired consciousness, breathing or heart problems, and death.
🧪 Tests and reports linked to Zolpidem Tartrate
The label text mentions these. If you have one of these reports, get every line of it explained.
- Kidney function tests
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- Liver function tests
a test or report linked to this medicine
- Pregnancy hCG test
a test or report linked to this medicine
📖 Medical words used on this page
- Allergic reaction
An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.
- Anaphylaxis
Anaphylaxis is a severe, whole-body allergic reaction that comes on fast and is a medical emergency needing urgent help.
- Angioedema
Angioedema is swelling deep under the skin, often of the lips, face, tongue or throat. Swelling of the throat or tongue needs emergency help.
- Antidepressant
An antidepressant is a medicine used to treat depression, and often anxiety, pain and other conditions, by acting on chemical messengers in the brain.
- Benzodiazepine
A benzodiazepine is a type of calming medicine used for anxiety, sleep problems, seizures or muscle spasm. It can cause drowsiness and dependence.
- Bilateral and unilateral
Bilateral means on both sides of the body and unilateral means on one side only, and reports usually also name the side.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- CNS depressant
A CNS depressant is any medicine or substance that slows down brain and nerve activity, causing drowsiness, relaxation or slower breathing.
- Congenital malformations
Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.
- Controlled substance
A controlled substance is a medicine or drug whose making, prescribing and supply are tightly regulated by law because it can be misused or cause dependence.
- Discontinuation syndrome
Discontinuation syndrome is a set of symptoms that can appear when a medicine, often an antidepressant, is stopped suddenly or reduced too fast.
- Edema
Edema is swelling caused by extra fluid trapped in the body's tissues, often in the feet, ankles and legs.
- Impression
The impression is the summary at the end of a scan report, where the radiologist gives the main conclusions.
- Major depressive disorder
Major depressive disorder is a common medical condition with low mood or loss of interest that lasts at least two weeks and affects daily life.
📖 Medical words on this page
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Explain my leafletDecode my prescription🔗 Trusted sources about Zolpidem Tartrate
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Zolpidem Tartrate on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Zolpidem Tartrate on the NHS website ↗
UK National Health Service medicine guide
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
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Source: official FDA drug label (label updated 2025-05-22). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.