Lunesta Side Effects

Generic Name: eszopiclone

Please note - some side effects for Lunesta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lunesta - for the Consumer

Lunesta

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lunesta:

Anxiety; decrease in sexual desire; difficulty with coordination; dizziness; drowsiness; dry mouth; headache; indigestion; lightheadedness; nausea; nervousness; unpleasant taste; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); aggressive behavior; breast growth; chest pain; confusion; depression; hallucinations; memory problems (such as amnesia); mental or mood changes; painful menstrual periods; seizures; severe mood swings; suicidal thoughts; swelling of hands or feet; symptoms of infection (eg, fever, sore throat, sinus or chest congestion); unusual or disturbing thoughts.

Lunesta Side Effects - for the Professional

Lunesta

The premarketing development program for Lunesta included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with Lunesta varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.

Adverse Findings Observed In Placebo-Controlled Trials

In placebo-controlled, parallel-group clinical trials in the elderly, 3.8% of 208 patients who received placebo, 2.3% of 215 patients who received 2 mg Lunesta, and 1.4% of 72 patients who received 1 mg Lunesta discontinued treatment due to an adverse event. In the 6-week parallel-group study in adults, no patients in the 3 mg arm discontinued because of an adverse event. In the long-term 6-month study in adult insomnia patients, 7.2% of 195 patients who received placebo and 12.8% of 593 patients who received 3 mg Lunesta discontinued due to an adverse event. No event that resulted in discontinuation occurred at a rate of greater than 2%.

Table 1 shows the incidence of treatment-emergent adverse events from a Phase 3 placebo-controlled study of Lunesta at doses of 2 or 3 mg in non-elderly adults. Treatment duration in this trial was 44 days. The table includes only events that occurred in 2% or more of patients treated with Lunesta 2 mg or 3 mg in which the incidence in patients treated with Lunesta was greater than the incidence in placebo-treated patients.

Adverse events from Table 1 that suggest a dose-response relationship in adults include viral infection, dry mouth, dizziness, hallucinations, infection, rash, and unpleasant taste, with this relationship clearest for unpleasant taste.

Table 2 shows the incidence of treatment-emergent adverse events from combined Phase 3 placebo-controlled studies of Lunesta at doses of 1 or 2 mg in elderly adults (ages 65-86). Treatment duration in these trials was 14 days. The table includes only events that occurred in 2% or more of patients treated with Lunesta 1 mg or 2 mg in which the incidence in patients treated with Lunesta was greater than the incidence in placebo-treated patients.

Adverse events from Table 2 that suggest a dose-response relationship in elderly adults include pain, dry mouth, and unpleasant taste, with this relationship again clearest for unpleasant taste.

These figures cannot be used to predict the incidence of adverse events in the course of usual medical practice because patient characteristics and other factors may differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contributions of drug and non-drug factors to the adverse event incidence rate in the population studied.

Other Events Observed During The Premarketing Evaluation Of Lunesta

Following is a list of modified COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section and reported by approximately 1550 subjects treated with Lunesta at doses in the range of 1 to 3.5 mg/day during Phase 2 and 3 clinical trials throughout the United States and Canada. All reported events are included except those already listed in Tables 1 and 2 or elsewhere in labeling, minor events common in the general population, and events unlikely to be drug-related. Although the events reported occurred during treatment with Lunesta, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those that occurred on one or more occasions in at least 1/100 patients; infrequent adverse events are those that occurred in fewer than 1/100 patients but in at least 1/1,000 patients; rare adverse events are those that occurred in fewer than 1/1,000 patients. Gender-specific events are categorized based on their incidence for the appropriate gender.

Body as a Whole: Frequent: chest pain; Infrequent: allergic reaction, cellulitis, face edema, fever, halitosis, heat stroke, hernia, malaise, neck rigidity, photosensitivity.

Cardiovascular System: Frequent: migraine; Infrequent: hypertension; Rare: thrombophlebitis.

Digestive System: Infrequent: anorexia, cholelithiasis, increased appetite, melena, mouth ulceration, thirst, ulcerative stomatitis; Rare: colitis, dysphagia, gastritis, hepatitis, hepatomegaly, liver damage, stomach ulcer, stomatitis, tongue edema, rectal hemorrhage.

Hemic and Lymphatic System: Infrequent: anemia, lymphadenopathy.

Metabolic and Nutritional: Frequent: peripheral edema; Infrequent: hypercholesteremia, weight gain, weight loss; Rare: dehydration, gout, hyperlipemia, hypokalemia.

Musculoskeletal System: Infrequent: arthritis, bursitis, joint disorder (mainly swelling, stiffness, and pain), leg cramps, myasthenia, twitching; Rare: arthrosis, myopathy, ptosis.

Nervous System: Infrequent: agitation, apathy, ataxia, emotional lability, hostility, hypertonia, hypesthesia, incoordination, insomnia, memory impairment, neurosis, nystagmus, paresthesia, reflexes decreased, thinking abnormal (mainly difficulty concentrating), vertigo; Rare: abnormal gait, euphoria, hyperesthesia, hypokinesia, neuritis, neuropathy, stupor, tremor.

Respiratory System: Infrequent: asthma, bronchitis, dyspnea, epistaxis, hiccup, laryngitis.

Skin and Appendages: Infrequent: acne, alopecia, contact dermatitis, dry skin, eczema, skin discoloration, sweating, urticaria; Rare: erythema multiforme, furunculosis, herpes zoster, hirsutism, maculopapular rash, vesiculobullous rash.

Special Senses: Infrequent: conjunctivitis, dry eyes, ear pain, otitis externa, otitis media, tinnitus, vestibular disorder; Rare: hyperacusis, iritis, mydriasis, photophobia.

Urogenital System: Infrequent: 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, vaginitis; Rare: oliguria, pyelonephritis, urethritis.

Side Effects by Body System

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. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.

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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