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Ambien CR Side Effects

Generic Name: zolpidem

Note: This document contains side effect information about zolpidem. Some of the dosage forms listed on this page may not apply to the brand name Ambien CR.

In Summary

Common side effects of Ambien CR include: drowsiness. Other side effects include: hallucination, myalgia, visual hallucination, anxiety, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zolpidem: oral tablet, oral tablet extended release

Other dosage forms:

Along with its needed effects, zolpidem (the active ingredient contained in Ambien CR) 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 while taking zolpidem:

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

For Healthcare Professionals

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

Common (1% to 10%): Palpitations, increased blood pressure
Uncommon (0.1% to 1%): Postural hypotension, hypertension, tachycardia, increased heart rate
Rare (less than 0.1%): Flushing, hypotension, hot flashes, angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, aggravated hypertension, myocardial infarction, phlebitis, varicose veins, ventricular tachycardia[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria, skin wrinkling
Uncommon (0.1% to 1%): Increased sweating/hyperhidrosis, pruritus, contact dermatitis
Rare (less than 0.1%): Acne, bullous eruption, dermatitis, furunculosis, photosensitivity reaction, angioneurotic edema[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth, abdominal pain, constipation, dyspepsia, hiccup, nausea, vomiting, gastroenteritis, abdominal discomfort, abdominal tenderness, frequent bowel movements, gastroesophageal reflux disease, flatulence
Rare (less than 0.1%): Altered saliva, increased saliva, tenesmus, enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries[Ref]

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

Common (1% to 10%): Allergy
Rare (less than 0.1%): Allergic reaction, aggravated allergy, anaphylactic shock
Frequency not reported: Angioedema, anaphylaxis[Ref]

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, stress symptoms, 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

Common (1% to 10%): Sinusitis, pharyngitis, upper respiratory infection, lower respiratory infection, throat irritation, nasopharyngitis, dry throat, rhinitis
Uncommon (0.1% to 1%): Bronchitis, coughing, dyspnea
Rare (less than 0.1%): Pulmonary embolism, pulmonary edema, yawning, bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia[Ref]

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]

References

1. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc, Louisville, KY.

2. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.

3. "Product Information. Ambien (zolpidem)." sanofi-aventis, Bridgewater, NJ.

4. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP, Stamford, CT.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc, New York, NY.

Some side effects of Ambien CR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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