Ambien

Name: Ambien

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • CNS-depressant effects and next-day impairment [see WARNINGS AND PRECAUTIONS]
  • Serious anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking and behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
  • Withdrawal effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Associated With Discontinuation Of Treatment

Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).

Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n =97) was discontinued after an attempted suicide.

Most Commonly Observed Adverse Reactions In Controlled Trials

During short-term treatment (up to 10 nights) with AMBIEN at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

Adverse reactions Observed At An Incidence Of ≥ 1% In Controlled Trials

The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.

Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (Percentage of patients reporting)

Body System/
Adverse Event*
Zolpidem
(≤10 mg)
(N=685)
Placebo
(N=473)
Central and Peripheral Nervous System
  Headache 7 6
  Drowsiness 2 -
  Dizziness 1 -
Gastrointestinal System
  Diarrhea 1 -
*Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.

The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.

Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 35 Nights (Percentage of patients reporting)

Body System/
Adverse Event*
Zolpidem
(≤10 mg)
(N=152)
Placebo
(N=161)
Autonomic Nervous System
  Dry mouth 3 1
Body as a Whole
  Allergy 4 1
  Back Pain 3 2
  Influenza-like symptoms 2 -
  Chest pain 1 -
Cardiovascular System
  Palpitation 2 -
Central and Peripheral Nervous System
  Drowsiness 8 5
  Dizziness 5 1
  Lethargy 3 1
  Drugged feeling 3 -
  Lightheadedness 2 1
  Depression 2 1
  Abnormal dreams 1 -
  Amnesia 1 -
  Sleep disorder 1 -
Gastrointestinal System
  Diarrhea 3 2
  Abdominal pain 2 2
  Constipation 2 1
Respiratory System
  Sinusitis 4 2
  Pharyngitis 3 1
Skin and Appendages
  Rash 2 1
*Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.

Dose Relationship For Adverse Reactions

There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem use, particularly for certain CNS and gastrointestinal adverse events.

Adverse Event Incidence Across The Entire Preapproval Database

AMBIEN was administered to,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with AMBIEN, they were not necessarily caused by it.

Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Autonomic nervous system:

Infrequent: increased sweating, pallor, postural hypotenson, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

Body as a whole:

Frequent: asthenia. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system:

Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system:

Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.

Gastrointestinal system:

Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.

Hematologic and lymphatic system:

Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.

Immunologic system:

Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.

Liver and biliary system:

Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.

Metabolic and nutritional:

Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.

Musculoskeletal system:

Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.

Reproductive system:

Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.

Respiratory system:

Frequent: upper respiratory infection, lower respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia.

Skin and appendages:

Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.

Special senses:

Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

Urogenital system:

Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of AMBIEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Liver and biliary system: acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin >2×ULN, alkaline phosphatase ≥2×ULN, transaminase ≥5×ULN).

Warnings

Included as part of the "PRECAUTIONS" Section

Overdose

Signs and Symptoms

In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.

Recommended Treatment

General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem’s sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable.

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

Ambien and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Actions

  • Interacts with the CNS GABA-benzodiazepine-chloride ionophore receptor complex.1 2 3 89

  • Selectivity for the type 1 benzodiazepine (BZ1) receptor not absolute, but may account for the decreased muscle relaxant, anxiolytic, and anticonvulsant effects compared with benzodiazepines reported in animal studies,1 2 3 4 6 7 89 as well as the preservation of deep sleep (stages 3 and 4) reported in human studies.1 4 89

Advice to Patients

  • Importance of providing patients a copy of the medication guide and discussing the contents with every patient prior to initiation of therapy.1 89 92 93 94 95 Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.1 89 92 93 94 95

  • Importance of informing patients and their families of the benefits and risks of zolpidem therapy.1 89 92 93 94 95

  • Importance of informing all patients (men and women) of the potential for next-day impairment, that the risk is increased if dosing instructions are not carefully followed, and that impairment may be present despite feeling fully awake.1 89 92 93 94 95

  • Importance of administering immediate-release zolpidem preparations intended for bedtime administration (conventional tablets, oral spray, 5- and 10-mg sublingual tablets [Edluar]) immediately before getting into bed, at least 7–8 hours before being active again.1 92 93 Wait ≥8 hours after taking the drug before driving or engaging in other activities requiring full mental alertness.1 92 93

  • Importance of administering extended-release zolpidem immediately before getting into bed, at least 7–8 hours before being active again.89 Avoid driving or engaging in other activities requiring complete mental alertness the day after taking this preparation.89

  • Importance of administering the 1.75- or 3.5-mg sublingual tablets (Intermezzo) in bed, only once per night as needed, if middle-of-the-night awakening is followed by difficulty returning to sleep, and only if ≥4 hours remain before planned time of awakening.94 Wait ≥4 hours after taking this preparation and until feeling fully awake before driving or engaging in other activities requiring full mental alertness.94

  • Potential risk of abnormal thinking and behavioral changes, including sleep-driving and other complex behaviors (e.g., preparing and eating food, making phone calls, having sex) while not being fully awake; importance of immediately informing clinician if any such changes occur.1 89 91

  • Importance of immediately informing clinician of any suicidal thoughts or memory impairment.1 89

  • Potential risk of severe anaphylactic and anaphylactoid reactions; importance of immediately seeking medical attention if manifestations of such reactions occur.1 89

  • Importance of taking zolpidem only as prescribed; do not increase dosage unless otherwise instructed by a clinician; inform clinician if the drug is not effective.1 89 92 93 94 95

  • Risk of withdrawal symptoms following abrupt discontinuance or rapid reduction in dosage.1 89 Importance of informing clinician of any tolerance or dependence/withdrawal symptoms.1 89

  • Importance of not taking zolpidem with or immediately after a meal.1 89 92 93 94

  • Importance of placing the zolpidem sublingual tablet (Edluar) under the tongue and allowing it to disintegrate; do not swallow or take with water.93

  • Importance of placing the zolpidem sublingual tablet (Intermezzo) under the tongue and allowing it to disintegrate completely before swallowing; do not swallow whole.94 Remove the tablet from the pouch just prior to dosing.94

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses, particularly depression.1 89

  • Importance of not taking zolpidem after consuming alcohol in the evening or before bedtime.1 89 92 93 94

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 89 92 93 94

  • Importance of informing patients of other important precautionary information.1 89 92 93 94 (See Cautions.)

How is this medicine (Ambien) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Use Ambien (zolpidem tablets) only for short periods of time (7 to 10 days).
  • If you still have trouble sleeping after 7 to 10 days, call your doctor.
  • Take this medicine at bedtime.
  • Take Ambien only 1 time per night.
  • Take on an empty stomach.
  • Take this medicine right before you get into bed.
  • Do not take Ambien unless you can get a full night's sleep (at least 7 to 8 hours) before you need to be active again.

What do I do if I miss a dose?

  • If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
  • If you will not be able to get a full night's sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Do not take more than 1 dose of Ambien in the same day.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

Drug Interactions

CNS-active Drugs

Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions (5.1)]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.

Imipramine, Chlorpromazine

Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [see Clinical Pharmacology (12.3)].

Haloperidol

A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration [see Clinical Pharmacology (12.3)].

Alcohol

An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1)].

Sertraline

Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see Clinical Pharmacology (12.3)].

Fluoxetine

After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance [see Clinical Pharmacology (12.3)].

Drugs that Affect Drug Metabolism via Cytochrome P450

Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of drugs that induce or inhibit other P450 enzymes on the exposure to zolpidem is not known.

CYP3A4 Inducers

Rifampin

Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem. Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended [see Clinical Pharmacology (12.3)].

St. John's wort

Use of St. John's wort, a CYP3A4 inducer, in combination with zolpidem may decrease blood levels of zolpidem and is not recommended.

CYP3A4 Inhibitors

Ketoconazole

Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together [see Clinical Pharmacology (12.3)].

Use in specific populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Ambien in pregnant women.

Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Ambien should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the Ambien maximum recommended human dose (MRHD) of 10 mg/day (approximately 8 mg/day zolpidem base); however, teratogenicity was not observed.

When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg/day to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg/day increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose tested. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 10 times the MRHD on a mg/m2 basis. Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis.

Labor and Delivery

Ambien has no established use in labor and delivery [see Pregnancy (8.1)].

Nursing Mothers

Zolpidem is excreted in human milk. Caution should be exercised when Ambien is administered to a nursing woman.

Pediatric Use

Ambien is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.

In an 8-week study, in pediatric patients (aged 6–17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the most frequent (> 5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions(5.4)]. Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.

Geriatric Use

A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥ 60 years of age. For a pool of U.S. patients receiving zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related).

Adverse Event Zolpidem Placebo
Dizziness 3% 0%
Drowsiness 5% 2%
Diarrhea 3% 1%

A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥ 70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥ 70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.

The dose of Ambien in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions (5.1)].

Gender Difference in Pharmacokinetics

Women clear zolpidem tartrate from the body at a lower rate than men. Cmax and AUC parameters of zolpidem were approximately 45% higher at the same dose in female subjects compared with male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of Ambien for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg.

In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of Ambien in geriatric patients is 5 mg regardless of gender.

Hepatic Impairment

The recommended dose of Ambien in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. Avoid Ambien use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Warnings and Precautions (5.7), Clinical Pharmacology (12.3)].

How Supplied/Storage and Handling

Ambien 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other and supplied as:

NDC Number Size
0024-5401-31 bottle of 100

Ambien 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:

NDC Number Size
0024-5421-31 bottle of 100
0024-5421-50 bottle of 500

Store at controlled room temperature 20°–25°C (68°–77°F).

What happens if i miss a dose (ambien, ambien cr, edluar, intermezzo, zolpimist)?

Since zolpidem is taken only at bedtime, you will not be on a frequent dosing schedule.

What should i avoid while taking zolpidem (ambien, ambien cr, edluar, intermezzo, zolpimist)?

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking zolpidem, 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 drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

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

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

Where can i get more information?

Your pharmacist can provide more information about zolpidem.

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

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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 Ambien and talk with your doctor about another treatment for your sleep disorder.

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

To make sure Ambien is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);

  • sleep apnea (breathing stops during sleep);

  • myasthenia gravis;

  • a history of depression, mental illness, or suicidal thoughts; or

  • a history of drug or alcohol addiction.

Ambien may be habit forming and should be used only by the person it was prescribed for. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

It is not known whether Ambien will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The sedative effects of zolpidem may be stronger in older adults.

Do not give this medicine to anyone younger than 18 years of age.

It is dangerous to try and purchase Ambien on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

How should I take Ambien?

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for Ambien, Edluar, and Zolpimist. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.

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.

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

Ambien may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. 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. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.

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.

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.
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