Summary
Commonly reported side effects of eszopiclone include: infection, drowsiness, and unpleasant taste. Other side effects include: nausea, dizziness, and xerostomia. Continue reading for a comprehensive list of adverse effects.
Applies to eszopiclone: oral tablets.
Warning
-
Risk of Serious Injury and Death Resulting From Complex Sleep Behaviors
- Serious injuries and/or death resulting from complex sleep behaviors (e.g., sleepwalking, sleep driving, and engaging in other activities while not fully awake) can occur following use of eszopiclone, zaleplon, and zolpidem.1 200
- Complex sleep behaviors have occurred in patients with and without a history of such behaviors and can occur even at the lowest recommended doses and after just one dose of these drugs.1 200
- Discontinue drug immediately if a complex sleep behavior occurs.1 200
Side effects include:
Adverse effects (reported in ≥2% of patients): Unpleasant taste, headache, somnolence, respiratory infection, dizziness, dry mouth, rash, anxiety, hallucinations, viral infection.
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]
