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Zolpidem is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).
Zolpidem is used to treat insomnia. The immediate-release forms are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.
Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.
Your doctor will determine which form of zolpidem is best for you.
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.
Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.
Never take this medicine in larger amounts or for longer than prescribed.
Do not take zolpidem if you have consumed alcohol during the day or just before bed.
Some people using zolpidem have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.
You should not use this medicine if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.
Zolpidem is not approved for use by anyone younger than 18 years old.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
depression, mental illness, or suicidal thoughts;
drug or alcohol addiction;
lung disease or breathing problems;
sleep apnea (breathing stops during sleep); or
liver or kidney disease.
Taking zolpidem in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.
Take zolpidem exactly as prescribed by your doctor, Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more or increase your dose.
Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.
Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.
Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row.
Store at room temperature away from moisture and heat. Do not freeze. Keep the medication in a place where others cannot get to it. Keep the Zolpimist bottle upright when not in use.
Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Insomnia symptoms may also return after you stop taking zolpidem, and may be even worse than before. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Since zolpidem is taken only at bedtime if needed, you are not likely to miss a dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking this medicine.
Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy in the morning, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Zolpidem may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to zolpidem: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.
Stop using this medicine and call your doctor at once if you have:
chest pain, fast or irregular heartbeat, feeling short of breath;
trouble breathing or swallowing; or
feeling like you might pass out.
The sedative effect of zolpidem may be stronger in older adults.
Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
Common zolpidem side effects may include:
daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
tired feeling, loss of coordination;
stuffy nose, dry mouth, nose or throat irritation;
nausea, constipation, diarrhea, upset stomach; or
headache, muscle pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Insomnia:
IMMEDIATE RELEASE (IR) TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations):
Initial dose:
-Women: 5 mg orally once a day immediately prior to bedtime
-Men: 5 to 10 mg orally once a day immediately prior to bedtime
Maintenance dose: 5 to 10 mg orally once a day immediately prior to bedtime
Maximum dose: 10 mg/day
CONTROLLED/EXTENDED RELEASE (CR/ER) TABLETS:
Initial dose:
-Women: 6.25 mg orally once a day immediately prior to bedtime
-Men: 6.25 to 12.5 mg orally once a day immediately prior to bedtime
Maintenance dose: 6.25 to 12.5 mg orally once a day immediately prior to bedtime
Maximum dose: 12.5 mg/day
SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Women: 1.75 mg orally once a day at night as needed
-Maximum dose: 1.75 mg/day
Men: 3.5 mg orally once a day at night as needed
-Maximum dose: 3.5 mg/day
Comments:
-The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.
-Clinical trials supporting IR tablet efficacy were 4 to 5 weeks' duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
-The 1.75 and 3.5 mg sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
-LIMITATION OF USE: The 1.75 and 3.5 mg sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.
Uses:
-IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
-CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
-Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep
Usual Geriatric Dose for Insomnia:
IR TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations): 5 mg orally once a day immediately prior to bedtime
-Maximum dose: 5 mg/day
CR/ER TABLETS:
Patients 65 years and over: 6.25 mg orally once a day at night immediately prior to bedtime
-Maximum dose: 6.25 mg/day
SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Patients over 65 years: 1.75 mg orally once a day at night as needed
-Maximum dose: 1.75 mg/day
Comments:
-Doses are the same in men and women.
-Clinical trials supporting IR tablet efficacy were 4 to 5 weeks' duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
-The 1.75 sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
-LIMITATION OF USE: The 1.75 sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.
Uses:
-IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
-CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
-Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep
Using zolpidem with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use zolpidem only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Zolpidem Tartrate (www.drugs.com/international/zolpidem.html).
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.
Applies to zolpidem: tablet
Other dosage forms:
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:
Less common
Rare
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
Less common
Applies to zolpidem: oral spray, oral tablet, oral tablet extended release, sublingual tablet
The most commonly reported side effects included dizziness, headache, and somnolence.
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
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
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
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
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
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
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
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
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
Common (1% to 10%): Infection, influenza, influenza-like symptoms
Rare (less than 0.1%): Abscess, herpes simplex, herpes zoster
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
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
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
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
Rare (less than 0.1%): Anemia, hyperhemoglobinemia, increased erythrocyte sedimentation rate (ESR), leukopenia, lymphadenopathy, macrocytic anemia
Rare (less than 0.1%): Acute renal failure, renal pain
Rare (less than 0.1%): Breast fibroadenosis, breast neoplasm
Rare (less than 0.1%): Injection-site inflammation
Frequency not reported: Transient paresthesia of the tongue, transient sublingual erythema
Tongue paresthesia and sublingual erythema occurred in patients given sublingual tablet formulations.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Zolpidem Tartrate (www.drugs.com/international/zolpidem.html).
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