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Eszopiclone is a sedative that is used to treat insomnia. eszopiclone causes relaxation to help you fall asleep and stay asleep.
Eszopiclone may also be used for purposes not listed in this medication guide.
Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, stop taking eszopiclone and call your doctor right away.
Serious injury or death could occur if you walk or drive while you are not fully awake.
You should not use eszopiclone if you are allergic to it, or if you have ever taken sleep medicine and engaged in activity you later don't remember.
Eszopiclone is not approved for use by anyone younger than 18 years old.
Tell your doctor if you have ever had:
liver disease;
a breathing disorder;
depression, mental illness, or suicidal thoughts; or
drug or alcohol addiction.
Tell your doctor if you are pregnant or breast-feeding.
The sedative effects of eszopiclone may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking eszopiclone.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Eszopiclone may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away eszopiclone is against the law.
Eszopiclone will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.
Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.
Do not stop using eszopiclone suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Insomnia symptoms may also return after you stop taking eszopiclone, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking eszopiclone.
Since eszopiclone is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medicine if you do not have at least 7 to 8 hours to sleep before being active again.
Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of eszopiclone can be fatal, especially when it is taken together with other medications that can cause drowsiness.
Avoid taking eszopiclone during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get at least 8 hours of sleep after taking eszopiclone.
Avoid drinking alcohol. Dangerous side effects or death could occur.
Avoid taking eszopiclone within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.
Eszopiclone can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking eszopiclone. Until you know how this medicine will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Eszopiclone may cause a severe allergic reaction. Stop taking eszopiclone and get emergency medical help if you have signs of an allergic reaction: hives; nausea, vomiting; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking eszopiclone and call your doctor right away.
Serious injury or death could occur if you walk or drive while you are not fully awake.
Call your doctor at once if you have:
anxiety, depression, aggression, agitation;
memory problems, unusual thoughts or behavior;
thoughts of hurting yourself; or
confusion, hallucinations (hearing or seeing things).
Common side effects may include:
day-time drowsiness, dizziness, "hangover" feeling;
headache, anxiety;
dry mouth;
unusual or unpleasant taste in your mouth;
rash; or
cold or flu symptoms such as fever, body aches, sore throat, cough, runny or stuffy nose.
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:
Initial dose: 1 mg orally once a day immediately before bedtime
Maintenance dose: 1 to 3 mg orally once a day immediately before bedtime
Maximum dose: 3 mg/day
Comments:
-The lowest effective dose should be used.
-Patients should be monitored for cognitive and/or motor impairments, especially if this drug is used repeatedly.
-Patients should be reevaluated if insomnia persists after 7 to 10 days of treatment.
Use: Treatment of insomnia
Usual Geriatric Dose for Insomnia:
Initial dose: 1 mg orally once a day immediately before bedtime
Maintenance dose: 1 to 2 mg orally once a day immediately before bedtime
Maximum dose: 2 mg/day
Comments:
-The lowest effective dose should be used.
-Patients should be monitored for cognitive and/or motor impairments, especially if this drug is used repeatedly.
-Patients should be reevaluated if insomnia persists after 7 to 10 days of treatment.
Use: Treatment of insomnia
Using eszopiclone with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures.
Other drugs may affect eszopiclone, including prescription and over-the-counter medicines, vitamins, and herbal products. 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 this medication 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 Eszopiclone (www.drugs.com/eszopiclone.html).
Commonly reported side effects of eszopiclone include: infection, drowsiness, and unpleasant taste. Other side effects include: nausea, dizziness, and xerostomia. See below for a comprehensive list of adverse effects.
Applies to eszopiclone: oral tablet
Along with its needed effects, eszopiclone 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 eszopiclone:
More common
Less common
Some side effects of eszopiclone 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
Incidence not known
Applies to eszopiclone: oral tablet
The most commonly reported side effects included unpleasant taste, headache, somnolence, and infection.
A dose-response relationship appears to exist for dizziness and unpleasant taste.
Headache was reported in 21% of non-elderly patients given 2 mg orally for 6 weeks, and in 17% of non-elderly adults given 3 mg orally for 6 weeks.
In patients 65 to 86 years of age, headache occurred in up to 15% of patients given 1 mg, and unpleasant taste occurred in up to 12% of patients given 2 mg orally for 2 weeks.
Dizziness and neuralgia commonly occurred in patients aged 65 years of age or older. Somnolence has also been reported in this patient population.
Very common (10% or more): Unpleasant taste (up to 34%), headache (up to 21%)
Common (1% to 10%): Dizziness, migraine, neuralgia, somnolence
Uncommon (0.1% to 1%): Ataxia, decreased reflexes, difficulty concentrating, hypertonia, hypesthesia, incoordination, memory impairment, nystagmus, paresthesia, vertigo, vestibular disorder
Rare (less than 0.1%): Abnormal gait, hyperesthesia, hypokinesia, neuritis, neuropathy, stupor, tremor
Postmarketing reports: Dysosmia
A dose-response relationship appears to exist for confusion, decreased libido, and hallucinations.
Abnormal dreams and nervousness commonly occurred in patients aged 65 years of age or older.
Common (1% to 10%): Abnormal dreams, anxiety, confusion, decreased libido, depression, hallucinations, nervousness
Uncommon (0.1% to 1%): Abnormal thinking, agitation, apathy, emotional lability, hostility, insomnia, neurosis,
Rare (less than 0.1%): Euphoria
A dose-response relationship appears to exist for dry mouth.
Diarrhea, dry mouth, and dyspepsia commonly occurred in patients aged 65 years of age or older. Abdominal pain and nausea have also been reported in this patient population.
Common (1% to 10%): Diarrhea, dry mouth, dyspepsia, nausea, vomiting
Uncommon (0.1% to 1%): Halitosis, melena, mouth ulceration, ulcerative stomatitis
Rare (less than 0.1%): Colitis, dysphagia, gastritis, rectal hemorrhage, stomach ulcer, stomatitis, tongue edema
Frequency not reported: Abdominal pain
Urinary tract infections commonly occurred in patients aged 65 years of age or older.
Common (1% to 10%): Dysmenorrhea, urinary tract infection
Uncommon (0.1% to 1%): Amenorrhea, breast engorgement, breast enlargement, breast pain, cystitis, dysuria, female lactation, hematuria, mastitis, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, uterine hemorrhage, vaginal hemorrhage, vaginitis
Rare (less than 0.1%): Urethritis
Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Acne, alopecia, cellulitis, contact dermatitis, dry skin, eczema, photosensitivity, skin discoloration, sweating, urticaria
Rare (less than 0.1%): Erythema multiforme, furunculosis, hirsutism, maculopapular rash, vesiculobullous rash
A dose-response relationship appears to exist for rash.
Pruritus commonly occurred in patients aged 65 years of age or older. Abdominal pain has also been reported in this patient population.
A dose-response relationship appears to exist for accidental injury and pain.
Accidental injury and pain commonly occurred in patients aged 65 years of age or older. Asthenia and pain have also been reported in this patient population.
Common (1% to 10%): Accidental injury, pain
Uncommon (0.1% to 1%): Ear pain, face edema, fever, hernia, malaise, otitis externa, otitis media, tinnitus
Rare (less than 0.1%): Hyperacusis
Frequency not reported: Asthenia
Common (1% to 10%): Chest pain, peripheral edema
Uncommon (0.1% to 1%): Heat stroke, hypertension
Rare (less than 0.1%): Thrombophlebitis
A dose-response relationship appears to exist for infection.
Common (1% to 10%): Infection, viral infection
Rare (less than 0.1%): Herpes zoster
Frequency not reported: Flu syndrome
Uncommon (0.1% to 1%): Allergic reaction
Common (1% to 10%): Gynecomastia
Uncommon (0.1% to 1%): Arthritis, bursitis, joint disorder, joint pain, joint swelling, joint stiffness, leg cramps, myasthenia, neck rigidity, twitching
Rare (less than 0.1%): Arthrosis, myopathy
Frequency not reported: Back pain, myalgia
Uncommon (0.1% to 1%): Anorexia, hypercholesterolemia, increased appetite, thirst, weight gain, weight loss
Rare (less than 0.1%): Dehydration, gout, hyperlipemia, hypokalemia
Uncommon (0.1% to 1%): Asthma, bronchitis, dyspnea, epistaxis, hiccup, laryngitis
Frequency not reported: Pharyngitis, rhinitis
Uncommon (0.1% to 1%): Conjunctivitis, dry eyes
Rare (less than 0.1%): Iritis, mydriasis, photophobia, ptosis
Uncommon (0.1% to 1%): Kidney calculus, kidney pain
Rare (less than 0.1%): Oliguria, pyelonephritis
Uncommon (0.1% to 1%): Anemia, lymphadenopathy
Uncommon (0.1% to 1%): Cholelithiasis
Rare (less than 0.1%): Hepatitis, hepatomegaly, liver damage
Uncommon (0.1% to 1%): Breast neoplasm
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Eszopiclone (www.drugs.com/eszopiclone.html).
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