Approval History Calendar Drug history at FDA.
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As well as its needed effects, zolpidem may cause unwanted side effects that require medical attention.
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.
Pregnancy Category C Risk cannot be ruled out.
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.
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:.
Postmarketing reports: Sublingual application site reactions (e.g., oral ulcers, blisters, mucosal inflammation).
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.
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.
Commonly reported side effects of zolpidem include: dizziness and drowsiness. See below for a comprehensive list of adverse effects. Other side effects include: myalgia, visual hallucination, anxiety, hallucination, and nausea.
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.
If any of the following side effects occur while taking zolpidem, check with your doctor immediay:
"UK Summary of Product Characteristics." O 0. Cerner Multum, Inc. 5.
Always consult a healthcare professional for medical advice. These can be reported to the FDA here. It is possible that some side effects of zolpidem may not have been reported.
Rare (less than 0.1%): Increased erythrocyte sedimentation rate (ESR), anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.
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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 immediay before bedtime.
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.
3. "Product Information. Ambien (zolpidem)." sanofi-aventis, Bridgewater, NJ.
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.
Common (1% to 10%): Allergy Rare (less than 0.1%): Allergic reaction, aggravated allergy, anaphylactic shock Frequency not reported: Angioedema, anaphylaxis.
Rare (less than 0.1%): Acute renal failure, renal pain.
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.
Insomnia melatonin, lorazepam, amitriptyline, zolpidem, Ambien, Ativan, temazepam, diphenhydramine, doxepin, Elavil, Restoril, Lunesta, Ibuprofen PM, eszopiclone, Belsomra, Rozerem, triazolam, zaleplon, Sonata, Silenor, doxylamine, Halcion, flurazepam, estazolam, More.
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.
2. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.
"Product Information. Intermezzo (zolpidem)." Purdue Pharma LP, Stamford, CT. 4.
Zolpimist (zolpidem)." Magna Pharmaceuticals Inc, Louisville, KY. "Product Information. 1.
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).
Other brands: Ambien, Zolpimist, Ambien CR, Intermezzo, Edluar.
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.
Applies to zolpidem: spray, tablet Other dosage forms:
For Healthcare Professionals Applies to zolpidem: oral spray, oral tablet, oral tablet extended release, sublingual tablet.
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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.
Availability Rx Prescription only.
CSA Schedule 4 Some potential for abuse.
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Ambien CR (zolpidem)." Sanofi-Synthelabo Inc, New York, NY. 6. "Product Information.Medication zolpidem