Lunesta Side Effects

Generic name: eszopiclone

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.

Some side effects of Lunesta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to eszopiclone: oral tablet

Eszopiclone may cause a severe allergic reaction. Stop taking eszopiclone (the active ingredient contained in Lunesta) and Get emergency medical help if you have any of these signs of an allergic reaction while taking eszopiclone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using eszopiclone and call your doctor at once if you have any of these serious side effects:

• aggression, agitation, changes in behavior;

• thoughts of hurting yourself; or

• hallucinations (hearing or seeing things).

Less serious side effects of eszopiclone may include:

• day-time drowsiness, dizziness, "hangover" feeling;

• problems with memory or concentration;

• anxiety, depression, nervous feeling;

• headache;

• nausea, stomach pain, loss of appetite, constipation;

• dry mouth;

• unusual or unpleasant taste in your mouth; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to eszopiclone: oral tablet

Other

Other side effects including unpleasant taste (up to 34%) and viral infection (3%) have been reported. Unpleasant taste (up to 12%) has been reported in patients 65 years of age and older. Lymphadenopathy, ear pain, otitis externa, otitis media, tinnitus, and vestibular disorder have been reported infrequently. Hyperacusis has been reported rarely.

Nervous system

Nervous system side effects including headache (up to 21%), somnolence (up to 10%), dizziness (up to 7%), nervousness (up to 5%), depression (up to 4%), anxiety (up to 3%), confusion (up to 3%), and hallucinations (up to 3%) have been reported. Headaches (up to 15%), dizziness (up to 6%), abnormal dreams (up to 3%), neuralgia (up to 3%), and nervousness (up to 2%) have been reported in patients 65 years of age and older. Agitation, apathy, emotional lability, hostility, hypertonia, hypesthesia, incoordination, insomnia, memory impairment, neurosis, nystagmus, paresthesia, decreased reflexes, abnormal thinking (mainly difficulty concentrating), and vertigo have been reported infrequently. Abnormal gait, euphoria, hyperesthesia, hypokinesia, neuritis, neuropathy, stupor and tremor have been reported rarely.

Respiratory

Respiratory side effects including infection (up to 10%) have been reported. Asthma, bronchitis, dyspnea, epistaxis, hiccup, and laryngitis have been reported infrequently.

Gastrointestinal

Gastrointestinal side effects including dry mouth (up to 7%), dyspepsia (up to 5%), nausea (up to 5%), and vomiting (up to 3%) have been reported. Dry mouth (up to 7%), dyspepsia (up to 6%), and diarrhea (up to 4%) have been reported in patients 65 years of age and older. Anorexia, cholelithiasis, increased appetite, melena, mouth ulceration, thirst, and ulcerative stomatitis have been reported infrequently. Colitis, dysphagia, gastritis, hepatitis, hepatomegaly, liver damage, stomach ulcer, stomatitis, tongue edema, and rectal hemorrhage have been reported rarely.

Dermatologic

Dermatologic side effects including rash (up to 4%) have been reported. Pruritus (up to 4%) has been reported in patients 65 years of age and older. Acne, alopecia, contact dermatitis, dry skin, eczema, skin discoloration, sweating, and urticaria have been reported infrequently. Erythema multiforme, furunculosis, herpes zoster, hirsutism, maculopapular rash, and vesiculobullous rash have been reported rarely.

Genitourinary

Genitourinary side effects including dysmenorrhea (up to 3%), gynecomastia (up to 3%), and decreased libido (up to 3%) have been reported. Urinary tract infections (up to 3%) have been reported in patients 65 years of age and older. Amenorrhea, breast engorgement, breast enlargement, breast neoplasm, breast pain, cystitis, dysuria, female lactation, hematuria, kidney calculus, kidney pain, mastitis, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, uterine hemorrhage, vaginal hemorrhage, and vaginitis have been reported infrequently. Oliguria, pyelonephritis, and urethritis have been reported rarely.

Oncologic

Oncologic side effects reported in animal studies have included an increase in mammary gland adenocarcinomas, pulmonary carcinomas, and carcinomas plus adenomas in females and an increase in thyroid gland follicular cell adenomas, carcinomas, skin fibromas, and sarcomas in males.

The increase in thyroid tumors in animal studies may be due to increased levels of TSH secondary to increased metabolism of circulating thyroid hormones, a mechanism that is not considered to be relevant to humans. The skin tumors were due to skin lesions induced by aggressive behavior in the animal population studies. This mechanism is also not considered to be relevant to humans.

General

General side effects including pain (up to 5%) and accidental injury (up to 3%) have been reported in patients 65 years of age and older. Chest pain was reported frequently. Cellulitis, facial edema, fever, halitosis, heat stroke, hernia, malaise, neck rigidity, and photosensitivity have been reported infrequently.

Hypersensitivity

Hypersensitivity side effects including allergic reaction have been reported infrequently. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including eszopiclone (the active ingredient contained in Lunesta) Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.

Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with eszopiclone should not be rechallenged with the drug.

Cardiovascular

Cardiovascular side effects have frequently included migraine. Hypertension has been reported infrequently. Thrombophlebitis has been reported rarely.

Hematologic

Hematologic side effects including anemia have been reported infrequently.

Metabolic

Metabolic side effects including peripheral edema have been reported frequently. Hypercholesterolemia, weight gain, and weight loss have been reported infrequently. Dehydration, gout, hyperlipemia, and hypokalemia have been reported rarely.

Musculoskeletal

Musculoskeletal side effects including arthritis, bursitis, joint disorder (mainly swelling, stiffness, and pain), leg cramps, myasthenia, and twitching have been reported infrequently. Arthrosis, myopathy, and ptosis have been reported rarely.

Ocular

Ocular side effects including conjunctivitis and dry eyes have been reported infrequently. Iritis, mydriasis, and photophobia have been reported rarely.

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