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Zolpidem

Generic Name: zolpidem (zole PI dem)
Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

Medically reviewed by P. Thornton, DipPharm. Last updated on May 15, 2019.

In summary

Zolpidem is a sedative (also called a hypnotic) used to treat insomnia. It helps induce sleep by enhancing the effects of GABA, a chemical transmitter in the brain. It is available under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. Some brands may be available as a generic.

Common side effects 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, headache, and muscle pain.

What is zolpidem?

Zolpidem is used to treat insomnia. The immediate-release forms of zolpidem are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is 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.

Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.

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

Zolpidem may also be used for purposes not listed in this medication guide.

Important information

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem 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.

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

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

Some people using zolpidem have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity.

Before taking zolpidem

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

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

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

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 zolpidem 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 zolpidem?

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

Follow the directions on your prescription label and read all medication guides. Never use zolpidem in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of zolpidem.

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

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.

Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.

Zolpidem 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.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medication in a place where others cannot get to it. Keep the Zolpimist bottle upright when not in use.

Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Insomnia symptoms may also return after you stop taking zolpidem, and may be even worse than before. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.

Zolpidem dosing information Pro

Usual Adult Dose for Insomnia:

Immediate Release (IR) Tablet, Oral Spray, and Sublingual Tablet (Edular):

  • Initial Dose: 5 mg (Women) OR 5 mg or 10 mg (Men)
  • Maintenance Dose: The dose may be increased to 10 mg if the 5 mg dose is not effective.
  • Maximum Dose: 10 mg once a day.
  • Duration of Therapy: The clinical trials in support of efficacy were 4 to 5 weeks in duration.

Controlled/Extended Release (CR/ER) Tablet:

  • Initial Dose: 6.25 mg (Women) OR 6.25 mg or 12.5 mg (Men)
  • Maintenance Dose: The dose may be increased to 12.5 mg if the 6.25 mg dose is not effective.
  • Maximum Dose: 12.5 mg once a day.
  • Duration of Therapy: The clinical trials in support of efficacy were up to 3 and 24 weeks in duration.

Sublingual Tablet (Intermezzo):

  • Initial and Maximum Dose: 1.75 mg (Women) OR 3.5 mg (Men)

Comments: The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.

Use:

  • IR Tablet, Oral Spray, and Sublingual Tablet (Edluar): Short-term treatment of insomnia characterized by difficulties with sleep initiation.
  • CR/ER Tablet: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
  • Sublingual Tablet (Intermezzo): As needed treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Usual Geriatric Dose for Insomnia:

  • Immediate Release (IR) Tablet, Oral Spray, and Sublingual Tablet (Edular): 5 mg
  • Extended Release Tablet: 6.25 mg
  • Sublingual Tablet (Intermezzo): Men and Women Over the Age of 65 Years: 1.75 mg

Usual Pediatric Dose for Insomnia:

  • Not recommended.

What happens if I miss a dose?

Since zolpidem 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 zolpidem?

Avoid taking zolpidem 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 zolpidem.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy the morning after taking zolpidem, 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.

Pregnancy and breastfeeding data Pro

Zolpidem Pregnancy Warnings

Cases of severe neonatal respiratory depression have been reported when this drug was used at the end of pregnancy, especially when used with other central nervous system (CNS) depressants. Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may be at risk for developing physical dependence and withdrawal symptoms in the postnatal period. Additionally, neonatal flaccidity also has been reported in infants born to mothers who received sedative/hypnotic drugs during pregnancy.

Animal studies have revealed no evidence of teratogenicity or fertility impairment, but adverse effects including incomplete fetal skeletal ossification and increased embryo-fetal death have occurred.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

AU, UK: Safety in pregnancy has not been established; avoid use in pregnancy, especially during the first trimester.

US: Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Comments:

  • Advise a female patient of childbearing potential to stop using this drug if she intends to become or suspects that she is pregnant.
  • Effects on the neonate (e.g., hypothermia, hypotonia, moderate respiratory depression) can be expected if this drug is administered during the late phase of pregnancy or during labor.

References

Zolpidem Breastfeeding Warnings

Breastmilk collected 3 hours after a single oral 20 mg dose of this drug was administered to 5 nursing mothers (who were 3 to 4 days postpartum) showed the breastmilk contained between 0.004% to 0.019% of the maternal dosage; the drug was undetectable (less than 0.5 mcg/L) in the breastmilk 13 and 16 hours after the dose.

In animals, administration of this drug during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose tested.

AU, UK: Use in nursing mothers is not recommended.

US: Use with caution in nursing mothers.

Excreted into human milk: Yes

Comments: Due to the low levels of this drug in breastmilk and its short half-life, amounts ingested by nursing infants are small and would not be expected to cause any adverse effects in these infants.

References

Zolpidem side effects

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem 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 zolpidem and call your doctor at once if you experience any of the following side effects

  • 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 zolpidem may be stronger in older adults. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common side effects

  • 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.

Zolpidem side effects by body system Pro

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[Ref]

Cardiovascular

Dermatologic

Gastrointestinal

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[Ref]

Hypersensitivity

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[Ref]

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[Ref]

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[Ref]

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)[Ref]

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, stresssymptoms, 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[Ref]

Respiratory

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[Ref]

Hematologic

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

Renal

  • Rare (less than 0.1%): Acute renal failure, renal pain[Ref]

Local

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

What other drugs will affect zolpidem?

Using zolpidem 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 affect 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.

Zolpidem drug interactions Pro

Further information

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

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

Related questions

More about zolpidem

Drug monograph Pro

Prescribing information Pro

References for pregnancy information

  1. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc, New York, NY.
  2. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP, Stamford, CT.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc, Louisville, KY.
  6. "Product Information. Ambien (zolpidem)." sanofi-aventis, Bridgewater, NJ.
  7. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Ambien (zolpidem)." sanofi-aventis, Bridgewater, NJ.
  5. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.
  6. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP, Stamford, CT.
  7. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc, New York, NY.
  8. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc, Louisville, KY.

Side effects by body system references

  1. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc, Louisville, KY.
  2. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.
  3. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP, Stamford, CT.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Ambien (zolpidem)." sanofi-aventis, Bridgewater, NJ.
  6. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc, New York, NY.
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