Ambien CR Side Effects

Generic name: zolpidem

Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

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

For Healthcare Professionals

Applies to zolpidem: oral capsule, oral spray, oral tablet, oral tablet extended release, sublingual tablet.

General

The most commonly reported side effects included dizziness, headache, and somnolence.^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 23.5%), headache (up to 19%), somnolence (up to 15%)

Common (1% to 10%): Amnesia, amnestic effects, anterograde amnesia, ataxia, attention disturbance, balance disorder, burning sensation, cognitive disorders, daytime drowsiness, drowsiness, drugged feelings, hypoesthesia, involuntary muscle contractions, lethargy, lightheadedness, memory disorders, memory impairment, paresthesia, postural dizziness, tremor, vertigo

Uncommon (0.1% to 1%): Cerebrovascular disorder, decreased cognition, difficulty concentrating, dysarthria, migraine, sleeping (with daytime dosing), speech disorder, stupor, syncope, taste perversion

Rare (less than 0.1%): Abnormal gait, dementia, depressed level of consciousness, gait disturbance, hypokinesia, hypotonia, neuralgia, neuritis, neuropathy, paresis, parosmia, restless legs, sciatica

Frequency not reported: Central nervous system (CNS)-depressant effects, impaired concentration, next-day impairment, next day somnolence

Postmarketing reports: Dysgeusia, memory disturbances, reduced alertness^[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, agitation, anxiety, apathy, binge eating, confusion, depersonalization, depressed mood, depression, disinhibition, disorientation, euphoria, euphoric mood, exacerbated insomnia, hallucinations, inappropriate behavior, insomnia, major depression, mood swings, nervousness, nightmare, psychomotor retardation, restlessness, sleep disorder, stress symptoms

Uncommon (0.1% to 1%): Aggression, confusional state, detached, emotional lability, hypnagogic hallucinations, illusion, irritability, somnambulism, visual hallucinations

Rare (0.01% to 0.1%): Abnormal thinking, aggressive reaction, attempted suicide, decreased libido, delusion, hysteria, libido disorder, manic reaction, neurosis, panic attacks, personality disorder

Very rare (less than 0.01%): Dependence, withdrawal effects/symptoms

Frequency not reported: Abnormal behavior, abnormal thinking, aggravated depression, anger, behavior changes, complex behaviors, continuing depression, hallucinations not otherwise specified (NOS), psychosis

Postmarketing reports: Aggravated insomnia, other adverse behavioral effects, perceptual disturbances, rages^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, frequent bowel movements, gastroesophageal reflux disease, nausea, vomiting

Uncommon (0.1% to 1%): Dysphagia

Rare (less than 0.1%): Altered saliva, enteritis, eructation, esophagospasm, gastritis, hemorrhoids, increased saliva, tenesmus, intestinal obstruction, rectal hemorrhage, tooth caries^[Ref]

Other

Common (1% to 10%): Asthenia, chest discomfort, contusion, exposure to poisonous plant, fatigue, increased body temperature, labyrinthitis, neck injury, otitis externa, pyrexia, tinnitus

Uncommon (0.1% to 1%): Fall/falling, fever, malaise, trauma

Rare (0.01% to 0.1%): Feeling strange, face edema, increased tolerance, intoxicated feeling, otitis media, pain, rigors

Very rare (less than 0.01%): Rebound effect

Frequency not reported: Drug tolerance

Postmarketing reports: Drunk feeling^[Ref]

Respiratory

Common (1% to 10%): Hiccup, lower respiratory infection, lower respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, sinusitis, throat irritation, upper respiratory infection, upper respiratory tract infection

Uncommon (0.1% to 1%): Bronchitis, coughing, dyspnea

Rare (less than 0.1%): Bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia, pulmonary edema, pulmonary embolism, respiratory depression, yawning

Postmarketing reports: Cough, dry throat^[Ref]

Ocular

Common (1% to 10%): Abnormal vision, altered visual depth perception, asthenopia, blurred vision, diplopia, eye redness, visual disturbance

Uncommon (0.1% to 1%): Eye irritation, eye pain, scleritis

Rare (0.01% to 0.1%): Abnormal accommodation, abnormal lacrimation, conjunctivitis, corneal ulceration, glaucoma, periorbital edema, photopsia

Very rare (less than 0.01%): Visual impairment^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, muscle cramp, myalgia, neck pain

Uncommon (0.1% to 1%): Arthritis, leg cramps, muscle spasms, muscle/muscular weakness

Rare (less than 0.1%): Arthrosis, tendinitis^[Ref]

Genitourinary

Common (1% to 10%): Dysuria, menorrhagia, urinary tract infection, vulvovaginal dryness

Uncommon (0.1% to 1%): Cystitis, menstrual disorder, urinary incontinence, vaginitis

Rare (less than 0.1%): Breast pain, impotence, micturition frequency, nocturia, polyuria, urinary retention

Postmarketing reports: Dysmenorrhea^[Ref]

Dermatologic

Common (1% to 10%): Rash, skin wrinkling, urticaria

Uncommon (0.1% to 1%): Hyperhidrosis, increased sweating, pruritus

Rare (less than 0.1%): Acne, bullous eruption, dermatitis, furunculosis, photosensitivity reaction, purpura

Frequency not reported: Angioneurotic edema

Postmarketing reports: Contact dermatitis^[Ref]

Immunologic

Common (1% to 10%): Infection, influenza, influenza-like symptoms

Rare (less than 0.1%): Abscess, herpes simplex, herpes zoster^[Ref]

Cardiovascular

Common (1% to 10%): Increased blood pressure, palpitations

Uncommon (0.1% to 1%): Chest pain, edema, hypertension, pallor, postural hypotension, tachycardia

Rare (less than 0.1%): Aggravated hypertension, angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, flushing, hot flashes, hypotension, myocardial infarction, phlebitis, thrombosis, varicose veins, ventricular tachycardia

Postmarketing reports: Increased heart rate^[Ref]

Metabolic

Common (1% to 10%): Anorexia, appetite disorder

Uncommon (0.1% to 1%): Hyperglycemia, thirst

Rare (less than 0.1%): Decreased weight, gout, hypercholesteremia, hyperlipidemia, increased appetite, tetany^[Ref]

Hypersensitivity

Common (1% to 10%): Allergy

Rare (less than 0.1%): Aggravated allergy, allergic reaction, anaphylactic shock

Frequency not reported: Angioedema, anaphylaxis, serious anaphylactic reactions, serious anaphylactoid reactions^[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, elevated liver enzymes, increased ALT

Rare (less than 0.1%): Bilirubinemia, cholestatic liver injury, hepatocellular liver injury, increased alkaline phosphatase, increased AST, mixed liver injury

Postmarketing reports: Acute hepatocellular, cholestatic, or mixed liver injury with or without jaundice^[Ref]

Hematologic

Rare (less than 0.1%): Anemia, hyperhemoglobinemia, increased erythrocyte sedimentation rate (ESR), leukopenia, lymphadenopathy, macrocytic anemia^[Ref]

Renal

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

Oncologic

Rare (less than 0.1%): Breast fibroadenosis, breast neoplasm^[Ref]

Local

Tongue paresthesia and sublingual erythema occurred in patients given sublingual tablet formulations.^[Ref]

Rare (less than 0.1%): Injection-site inflammation

Frequency not reported: Transient paresthesia of the tongue, transient sublingual erythema^[Ref]

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Further information

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

Some side effects may not be reported. You may report them to the FDA.

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