Edluar Side Effects

Generic name: zolpidem

Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.

Note: This document provides detailed information about Edluar Side Effects associated with zolpidem. Some dosage forms listed on this page may not apply specifically to the brand name Edluar.

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

Other dosage forms:

• tablet

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine during the last 3 months of pregnancy can harm your newborn baby. Check with your doctor right away if your baby has pale or blue lips, fingernails, or skin, difficult or trouble breathing, excessive sleepiness, or limpness. Tell your doctor right away if you are pregnant or if you think you have become pregnant while using this medicine.

If you think you need to take zolpidem (the active ingredient contained in Edluar) for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

Zolpidem may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that any of these has happened.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you Stop taking zolpidem. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally, which may lead to falls. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems, or severe injuries (eg, hip fractures, severe bleeding in the head). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you develop any unusual and strange thoughts or behavior while you are using zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people using this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not change your dose or stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including confusion as to time, place, or person, hallucinations, holding false beliefs that cannot be changed by fact, seizures, stomach or muscle cramps, tremors, unusual excitement, nervousness, or restlessness, or vomiting.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to serious breathing problems (eg, respiratory depression) and unconsciousness. Symptoms of an overdose include: severe drowsiness, severe nausea or vomiting, staggering, and trouble breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Common side effects of Edluar

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:

Serious side effects of Edluar

Along with its needed effects, zolpidem 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:

Get emergency help immediately if any of the following symptoms of overdose occur while taking zolpidem:

Symptoms of overdose

• change or loss of consciousness
• difficult or trouble breathing
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• sleepiness or unusual drowsiness

See also:

For healthcare professionals

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

General adverse events

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

• Rare (less than 0.1%): Injection-site inflammation
• Frequency not reported: Transient paresthesia of the tongue, transient sublingual erythema^[Ref]

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

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Further information

Edluar side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer