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Eszopiclone Side Effects

In Summary

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.

For the Consumer

Applies to eszopiclone: oral tablet

Warning

Oral route (Tablet)

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone. Some of these events may result in serious injuries, including death. Discontinue eszopiclone immediately if a patient experiences a complex sleep behavior.

Side effects requiring immediate medical attention

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

  • Chills
  • cough
  • fever
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • sleepiness or unusual drowsiness

Less common

  • Bladder pain
  • bloody or cloudy urine
  • confusion
  • diarrhea
  • discouragement
  • fear or nervousness
  • feeling sad or empty
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • irritability
  • joint pain
  • lack of appetite
  • loss of interest or pleasure
  • muscle aches and pains
  • nausea
  • nerve pain
  • runny nose
  • seeing, hearing, or feeling things that are not there
  • shivering
  • sore throat
  • sweating
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

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

Symptoms of overdose

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

Side effects not requiring immediate medical attention

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

  • Abnormal dreams
  • accidental injury
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • pain, cramps, or heavy bleeding (females)
  • rash
  • swelling of the breasts or breast soreness (in both males and females)

Incidence not known

  • Change in sense of smell
  • loss of memory
  • problems with memory

For Healthcare Professionals

Applies to eszopiclone: oral tablet

General

The most commonly reported side effects included unpleasant taste, headache, somnolence, and infection.[Ref]

Nervous system

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.[Ref]

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[Ref]

Psychiatric

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.[Ref]

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[Ref]

Gastrointestinal

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.[Ref]

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[Ref]

Genitourinary

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[Ref]

Urinary tract infections commonly occurred in patients aged 65 years of age or older.[Ref]

Dermatologic

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.[Ref]

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[Ref]

Other

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.[Ref]

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[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, peripheral edema

Uncommon (0.1% to 1%): Heat stroke, hypertension

Rare (less than 0.1%): Thrombophlebitis[Ref]

Immunologic

A dose-response relationship appears to exist for infection.[Ref]

Common (1% to 10%): Infection, viral infection

Rare (less than 0.1%): Herpes zoster

Frequency not reported: Flu syndrome[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction[Ref]

Endocrine

Common (1% to 10%): Gynecomastia[Ref]

Musculoskeletal

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[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, hypercholesterolemia, increased appetite, thirst, weight gain, weight loss

Rare (less than 0.1%): Dehydration, gout, hyperlipemia, hypokalemia[Ref]

Respiratory

Uncommon (0.1% to 1%): Asthma, bronchitis, dyspnea, epistaxis, hiccup, laryngitis

Frequency not reported: Pharyngitis, rhinitis[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, dry eyes

Rare (less than 0.1%): Iritis, mydriasis, photophobia, ptosis[Ref]

Renal

Uncommon (0.1% to 1%): Kidney calculus, kidney pain

Rare (less than 0.1%): Oliguria, pyelonephritis[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, lymphadenopathy[Ref]

Hepatic

Uncommon (0.1% to 1%): Cholelithiasis

Rare (less than 0.1%): Hepatitis, hepatomegaly, liver damage[Ref]

Oncologic

Uncommon (0.1% to 1%): Breast neoplasm[Ref]

References

1. "Product Information. Lunesta (eszopiclone)." Sepracor Inc, Marlborough, MA.

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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