This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lunesta (Eszopiclone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (78)
Death (7)
Life Threatening Events (6)
Disability (3)
Reports by Reaction Type
Drug Ineffective (16),
Insomnia (15),
Somnolence (7),
Agitation (6),
Fatigue (6),
Depression (6),
Anxiety (6),
Middle Insomnia (6),
Somnambulism (6),
Confusional State (5),
Headache (5),
Abnormal Dreams (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Lunesta (Eszopiclone). For a complete list or a specific selection of reports, please use the links above.
Possible Lunesta side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 79 year old female
Reactions: Hallucination, Visual, Hallucination, Auditory, Drug Interaction, Toxicity To Various Agents, Somnolence, Crying
Drug(s) suspected as cause:
Lunesta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Oxycontin
Indication: Pain
Oxycontin
Lexapro
Indication: Depression
Start date: 2007-01-01
Morphine
Indication: Pain
Start date: 2011-11-01
End date: 2012-02-01
Other drugs received by patient: Vicodin
Possible Lunesta side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 61 year old male
Reactions: Abnormal Dreams, Peripheral Coldness, Inappropriate Schedule of Drug Administration, Muscle Atrophy, Middle Insomnia, Arthralgia, Arterial Thrombosis Limb
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lunesta
Administration route: Oral
Start date: 2010-12-01
End date: 2012-03-01
Lunesta
Administration route: Oral
Indication: Sleep Disorder
Start date: 2012-04-01
Other drugs received by patient: Citalopram; Celebrex; Trazodone Hydrochloride; Oxycodone HCL; Zantac; Plavix; Losartan Potassium
Possible Lunesta side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 79 year old female
Reactions: Hallucination, Auditory, Hallucination, Visual, Drug Interaction, Toxicity To Various Agents, Somnolence, Crying
Drug(s) suspected as cause:
Oxycontin
Indication: Pain
Morphine
Indication: Pain
Start date: 2011-11-01
End date: 2012-02-01
Lunesta
Dosage: 3 mg
Oxycontin
Dosage: 40 mg every 8 hours as needed
Lexapro
Dosage: 20 mg
Administration route: Oral
Indication: Depression
Start date: 2007-01-01
Other drugs received by patient: Vicodin
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: female
Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain
Drug(s) suspected as cause:
Trileptal
Tizanidine Hydrochloride
Indication: Migraine
Depakote
Darvocet-N 50
Skelaxin
Prozac
Paxil
Lunesta
Beta Blocking Agents
Topamax
Zonegran
Valium
Indication: Agitation
Reglan
Abilify
Elavil
Zyprexa
Tegretol
Requip
MAO Inhibitors
Remeron
Buspar
Adderall
Erythromycin
Ritalin
Effexor
Sumatriptan
Wellbutrin
Tofranil
Zoloft
Daytrana
Antidepressants
Steroids NOS
Desyrel
Neurontin
Sinequan
Seroquel
Pamelor
Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY
Possible Lunesta side effects in 45 year old male
Reported by a physician from United States on 2012-08-06
Patient: 45 year old male
Reactions: Blood Pressure Increased, Blood Creatine Phosphokinase Increased, Muscular Weakness, Headache, Hypoaesthesia, Paraesthesia, Myopathy, Uhthoff's Phenomenon, Palpitations, Chest Pain, Intervertebral Disc Degeneration, Sinus Tachycardia, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2009-01-01
End date: 2012-06-23
Lunesta
Administration route: Oral
Indication: Insomnia
Start date: 2011-10-01
Alcohol
Dosage: 6-8 beers per day 5 out of 7 days per week.
Alcohol
Lunesta
Administration route: Oral
End date: 2012-07-01
Other drugs received by patient: Ibuprofen
Possible Lunesta side effects in 28 year old male
Reported by a individual with unspecified qualification from United States on 2012-08-02
Patient: 28 year old male, weighing 81.6 kg (179.5 pounds)
Reactions: Insomnia, Sensation of Heaviness, Muscular Weakness, Asthenia
Drug(s) suspected as cause:
Seroquel
Administration route: Oral
Indication: Schizoaffective Disorder
Klonopin
Indication: Sleep Disorder
Lunesta
Indication: Sleep Disorder
Seroquel
Administration route: Oral
Start date: 2012-01-01
Klonopin
Indication: Anxiety
Seroquel
Administration route: Oral
Indication: Insomnia
Seroquel
Administration route: Oral
Start date: 2012-01-01
Possible Lunesta side effects in 38 year old female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 38 year old female, weighing 77.1 kg (169.6 pounds)
Reactions: Myalgia, Bone Pain, Oedema
Drug(s) suspected as cause:
Lunesta
Administration route: Oral
Indication: Insomnia
Start date: 2011-10-01
Levothyroxine Sodium
Administration route: Oral
Indication: Hypothyroidism
Start date: 2011-10-01
Cymbalta
Administration route: Oral
Indication: Depression
Start date: 2011-10-01
Other drugs received by patient: Clonazepam
Possible Lunesta side effects in 39 year old female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 39 year old female, weighing 79.4 kg (174.7 pounds)
Reactions: Malaise, Drug Ineffective, Insomnia, Intentional Drug Misuse
Drug(s) suspected as cause:
Ambien
Lunesta
Seroquel
Administration route: Oral
Indication: Bipolar Disorder
Seroquel
Administration route: Oral
Indication: Depression
Other drugs received by patient: Other Prescription; Other Prescription
Possible Lunesta side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: 71 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Wrong Technique in Drug Usage Process, Platelet Count Increased, Intentional Drug Misuse, Somnolence, Fall, Off Label Use, Abnormal Dreams, Weight Increased, Fatigue, Throat Irritation, Insomnia, Depressed Mood, Feeling Abnormal
Drug(s) suspected as cause:
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Lunesta
Lunesta
Start date: 2007-01-01
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Insomnia
Start date: 2006-01-01
Seroquel
Administration route: Oral
Indication: Depression
Start date: 2006-01-01
Seroquel
Administration route: Oral
Indication: Sleep Disorder
Start date: 2006-01-01
Seroquel
Administration route: Oral
Other drugs received by patient: Enalapril Maleate; Enalapril Maleate; Atenolol
Possible Lunesta side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: 74 year old female
Reactions: Coronary Artery Occlusion, Myocardial Infarction
Drug(s) suspected as cause:
Lunesta
Possible Lunesta side effects in 24 year old female
Reported by a pharmacist from Japan on 2012-07-19
Patient: 24 year old female
Reactions: Epilepsy
Drug(s) suspected as cause:
Lunesta
Administration route: Oral
Start date: 2012-05-01
Lunesta
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-01
End date: 2012-05-01
Other drugs received by patient: ALL Other Therapeutic Products; Clotiazepam
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female
Reactions: Anxiety, Abdominal Discomfort, Suicide Attempt, Depression
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Lunesta
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Halcion
Dosage: unk
Lunesta
Dosage: unk
Ambien
Dosage: unk
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: female
Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Toxicity To Various Agents, Rash, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain
Drug(s) suspected as cause:
Tegretol
Requip
Neurontin
Darvocet-N 50
Remeron
Reglan
Depakote
Imitrex
Zonegran
Erythromycin
Ritalin
Sinequan
Elavil
Adderall 5
Wellbutrin
Pamelor
Prozac
Buspar
Lunesta
Trileptal
Topamax
Beta Blocking Agents
Abilify
Valium
Indication: Agitation
Steroids NOS
Seroquel
MAO Inhibitors
Tofranil
Zoloft
Paxil
Daytrana
Effexor
Skelaxin
Antidepressants
Tizanidine Hydrochloride
Desyrel
Zyprexa
Other drugs received by patient: Vitamin B-Complex, Other Combinations; Caltrate +D; Ensure; ONE A DAY; Aspirin
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: female, weighing 74.4 kg (163.6 pounds)
Reactions: Drug Ineffective, Insomnia, Blood Thyroid Stimulating Hormone Increased
Drug(s) suspected as cause:
Cytomel
Dosage: unk
Administration route: Oral
Indication: Hypothyroidism
Ambien
Dosage: unk
Indication: Insomnia
Sonata
Dosage: unk
Indication: Insomnia
Acetaminophen
Dosage: unk
Indication: Insomnia
Lunesta
Dosage: unk
Indication: Insomnia
Synthroid
Dosage: 75 ug, unk
Administration route: Oral
Indication: Hypothyroidism
Synthroid
Dosage: unk
Administration route: Oral
Possible Lunesta side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-13
Patient: male
Reactions: Dyspnoea, Contusion, Gout, Stent Placement, Ulcer, Irritability, Feeling Hot, Blood Pressure Abnormal, Injury
Drug(s) suspected as cause:
Lisinopril
Dosage: unk, unknown
Lunesta
Dosage: unk, unknown
Effient
Dosage: 10 mg, qd
Indication: Stent Placement
Start date: 2011-03-01
Possible Lunesta side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: 71 year old female, weighing 57.6 kg (126.7 pounds)
Reactions: Confusional State, Weight Decreased, Dyspnoea, Drug Hypersensitivity, Disorientation, Amnesia, Grand MAL Convulsion, Emotional Distress, Activities of Daily Living Impaired, Visual Impairment, Heart Rate Increased, Vision Blurred, Sleep Apnoea Syndrome, Hallucination
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Lunesta
Dosage: 2 tablets by mouth at night
Administration route: Oral
Indication: Anxiety
Start date: 2012-01-01
End date: 2012-01-01
Lunesta
Dosage: 2 tablets by mouth at night
Administration route: Oral
Indication: Insomnia
Start date: 2012-01-01
End date: 2012-01-01
Cymbalta
Dosage: 1 capsule at night
Indication: Insomnia
Start date: 2012-01-01
End date: 2012-01-01
Cymbalta
Dosage: 1 capsule at night
Indication: Anxiety
Start date: 2012-01-01
End date: 2012-01-01
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: Agitation, Confusional State, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Tremor, Convulsion, Weight Increased, Bipolar Disorder, Chest Pain
Drug(s) suspected as cause:
Skelaxin
Elavil
Prozac
Reglan
Tegretol
Depakote
Steroids NOS
Zonegran
MAO Inhibitors
Pamelor
Paxil
Requip
Sinequan
Abilify
Remeron
Tofranil
Buspar
Topamax
Imitrex
Darvocet-N 50
Seroquel
Tizanidine Hydrochloride
Adderall 5
Neurontin
Beta Blocking Agents
Desyrel
Zoloft
Ritalin
Trileptal
Valium
Indication: Agitation
Lunesta
Daytrana
Erythromycin
Effexor
Antidepressants
Wellbutrin
Zyprexa
Other drugs received by patient: Aspirin; Caltrate +D; ONE A DAY; Vitamin B-Complex, Other Combinations; Ensure
Possible Lunesta side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: male
Reactions: Abnormal Dreams, Insomnia
Drug(s) suspected as cause:
Lunesta
Dosage: unk
Indication: Insomnia
Chantix
Dosage: unk
Chantix
Dosage: unk
Possible Lunesta side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-30
Patient: 24 year old female
Reactions: Epilepsy
Drug(s) suspected as cause:
Lunesta
Administration route: Oral
Start date: 2012-05-01
Lunesta
Administration route: Oral
Indication: Insomnia
Start date: 2012-05-01
End date: 2012-05-01
Other drugs received by patient: Clotiazepam
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female
Reactions: Somnolence
Drug(s) suspected as cause:
Lunesta
Dosage: 3 mg, (hs) once nightly at bedtime
Administration route: Oral
Indication: Insomnia
Start date: 2009-01-01
Lyrica
Dosage: unk
Indication: Back Pain
Start date: 2011-07-01
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-25
Patient: female
Reactions: Muscle Contractions Involuntary, Muscle Twitching, Joint Stiffness
Drug(s) suspected as cause:
Zoloft
Dosage: unk
Flexeril
Dosage: unk
Lunesta
Dosage: unk
Lamictal
Dosage: unk
Possible Lunesta side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-25
Patient: male
Reactions: Suicide Attempt
Drug(s) suspected as cause:
Lunesta
Indication: Product Used FOR Unknown Indication
Celexa
Indication: Product Used FOR Unknown Indication
Percocet
Indication: Product Used FOR Unknown Indication
Xanax
Indication: Product Used FOR Unknown Indication
Oxycodone HCL
Indication: Product Used FOR Unknown Indication
Ambien
Indication: Product Used FOR Unknown Indication
Klonopin
Indication: Product Used FOR Unknown Indication
Possible Lunesta side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: male
Reactions: Abnormal Dreams, Insomnia
Drug(s) suspected as cause:
Chantix
Dosage: unk
Lunesta
Dosage: unk
Indication: Insomnia
Possible Lunesta side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: 59 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lunesta
Possible Lunesta side effects in 20 year old female
Reported by a physician from United States on 2012-05-17
Patient: 20 year old female, weighing 55.3 kg (121.7 pounds)
Reactions: Confusional State, Incorrect Dose Administered, Memory Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lunesta
Possible Lunesta side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Lunesta
Possible Lunesta side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04
Patient:
Reactions: Dysgeusia
Drug(s) suspected as cause:
Lunesta
Dosage: unk
Pristiq
Dosage: unk
Possible Lunesta side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04
Patient: male
Reactions: Abdominal Pain, Urticaria, Local Swelling, Rash, Depression
Drug(s) suspected as cause:
Lyrica
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-01-01
Lunesta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-01-01
Nucynta
Administration route: Oral
Indication: Analgesic Therapy
Start date: 2012-01-01
End date: 2012-01-01
Possible Lunesta side effects in female
Reported by a lawyer from United States on 2012-05-01
Patient: female, weighing 74.4 kg (163.6 pounds)
Reactions: Agitation, Drug Ineffective, Folliculitis, Bipolar II Disorder, Obesity, Depression, Sinusitis, Arteriosclerosis, Migraine, Libido Decreased, Stress, Seborrhoea, Anxiety, Cholelithiasis, Hysterectomy, Affective Disorder, Insomnia, Withdrawal Syndrome, Memory Impairment, Feeling Abnormal, Respiratory Tract Infection, Salpingo-Oophorectomy Bilateral
Drug(s) suspected as cause:
Zoloft
Dosage: 50 mg, 1x/day
Start date: 1999-06-15
Effexor
Dosage: 75 mg, 1x/day
Indication: Anxiety
Start date: 2006-10-17
Zoloft
Dosage: 25mg, a day for seven days
Indication: Depression
Start date: 1999-03-01
End date: 1999-03-07
Xanax
Dosage: 0.5 mg, every 8 hours
Start date: 2002-11-19
Wellbutrin
Dosage: 200mg, one daily
Indication: Depression
Start date: 2004-05-18
End date: 2004-05-20
Lortab
Dosage: 7.5/500 one every 6-8 hours as needed
Indication: Headache
Start date: 2004-01-01
End date: 2005-02-02
Zoloft
Dosage: 50 mg, 2x/day
Start date: 1999-12-06
Xanax
Dosage: 0.25 mg, 2x/day
Indication: Anxiety
Calan
Dosage: unk
Indication: Migraine
Wellbutrin
Dosage: 150 mg, 1x/day
Indication: Affective Disorder
Start date: 2004-11-11
Topamax
Dosage: 25 mg, at night for 17 days
Start date: 2004-05-04
Midrin
Dosage: two capsules at start of migraine
Indication: Migraine
Start date: 2011-11-11
Excedrin (Migraine)
Indication: Migraine
Zoloft
Dosage: 75 mg, 1x/day
Indication: Adjustment Disorder
Start date: 1999-06-01
Effexor
Dosage: 37.5 mg, 1x/day
Indication: Depression
Start date: 2006-10-10
End date: 2006-10-16
Lunesta
Dosage: unk
Indication: Sleep Disorder
Start date: 2009-06-01
Topamax
Dosage: 25 mg, x7days in the morning
Start date: 2005-02-16
Mirapex
Indication: Sleep Disorder
Paxil
Dosage: 20 mg, 1x/day
Start date: 1999-01-01
Zoloft
Dosage: 20 mg, 1x/day for 4 weeks
Zoloft
Dosage: 100 mg, for 6 months
Start date: 2004-06-23
Ultram
Dosage: 50 mg, as needed, every 8 hours
Indication: Headache
Start date: 2004-11-17
Wellbutrin
Dosage: 300 mg, unk
Start date: 2004-11-17
Zoloft
Dosage: 50mg, for four weeks
Indication: Affective Disorder
Start date: 1999-03-08
Zoloft
Dosage: 100 mg, 1x/day
Start date: 1999-07-27
Zoloft
Dosage: 75 mg, unk
Start date: 2002-11-19
Zoloft
Dosage: 50 mg, unk
Administration route: Oral
Start date: 2002-05-20
Inderal LA
Dosage: 60mg 1 at night
Topamax
Dosage: 25, twice a day for seven days
Indication: Migraine
Start date: 2005-02-02
Lortab
Dosage: 5/500 one every 8 hours as needed
Start date: 2005-01-18
End date: 2005-02-02
Cymbalta
Dosage: 30 mg, 1x/day
Indication: Insomnia
Paxil
Dosage: 10 mg, 1x/day
Administration route: Oral
Start date: 1999-06-01
Elavil
Dosage: unk
Indication: Migraine
Lexapro
Dosage: 10 mg, unk
Start date: 2004-06-23
Topamax
Dosage: 50 mg and 25 mg in the morning for 7 days
Start date: 2005-02-09
Motrin
Indication: Migraine
Other drugs received by patient: Ortho-Novum
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