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Zolpidem Side Effects

In Summary

Commonly reported side effects of zolpidem include: dizziness and drowsiness. Other side effects include: myalgia, visual hallucination, anxiety, hallucination, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zolpidem: spray, tablet

As well as its needed effects, zolpidem may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking zolpidem, check with your doctor immediately:

Less common:
  • Clumsiness or unsteadiness
  • confusion
  • depression
Rare
  • Difficulty with breathing
  • dizziness, lightheadedness, or fainting
  • falling
  • fast heartbeat
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • swelling of the face
  • trouble sleeping
  • unusual excitement, nervousness, or irritability
  • wheezing

Minor Side Effects

Some zolpidem side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Sleepiness or unusual drowsiness
Less common:
  • Abdominal or stomach pain
  • abnormal or decreased touch sensation
  • abnormal sensation of movement
  • appetite disorder
  • balance disorder
  • binge eating
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • chest discomfort
  • chills
  • confusion about identity, place, and time
  • constipation
  • continuous ringing, buzzing, or other unexplained noise in the ears
  • daytime drowsiness
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • difficulty with swallowing
  • discouragement
  • double vision
  • drugged feeling
  • dry mouth
  • earache
  • eye redness
  • false or unusual sense of well-being
  • feeling of unreality
  • feeling sad or empty
  • frequent bowel movements
  • frequent urge to urinate
  • headache
  • hearing loss
  • heartburn
  • hives or welts
  • itching ears
  • joint pain
  • lack of appetite
  • lack of feeling or emotion
  • lack or loss of self-control
  • lack or loss of strength
  • longer or heavier menstrual periods
  • loss of balance
  • loss of interest or pleasure
  • memory problems
  • mood swings
  • muscle aches, cramping, pain, or stiffness
  • nausea
  • nightmares or unusual dreams
  • redness of the skin
  • redness or soreness of the throat
  • sense of detachment from self or body
  • slowing of mental and physical activity
  • sneezing
  • stuffy or runny nose
  • swollen joints
  • tiredness
  • trouble concentrating
  • vision changes
  • vomiting

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.

It is possible that some side effects of zolpidem may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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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