Lunesta

Note: This document contains side effect information about eszopiclone. Some of the dosage forms listed on this page may not apply to the brand name Lunesta.

Common side effects of Lunesta 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 (the active ingredient contained in Lunesta) 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

• Cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• sleepiness or unusual drowsiness

Less common

• Bladder pain
• bloody or cloudy urine
• cold flu-like symptoms
• confusion
• difficult, burning, or painful urination
• discouragement
• fear or nervousness
• feeling sad or empty
• frequent urge to urinate
• irritability
• lack of appetite
• loss of interest or pleasure
• nerve pain
• seeing, hearing, or feeling things that are not there
• tiredness
• trouble concentrating
• trouble sleeping

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

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• change in taste
• dizziness
• dry mouth
• headache
• heartburn
• indigestion
• nausea
• pain
• stomach discomfort, upset, or pain

Less common

• Abnormal dreams
• accidental injury
• decreased interest in sexual intercourse
• diarrhea
• 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)
• vomiting

Incidence not known

• Loss of memory
• problems with memory

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