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Sonata Side Effects

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Common Sonata Side Effects


The most commonly reported Sonata side effects (click to view or check a box to report):

Intentional Misuse (11)
Overdose (10)
Suicide Attempt (10)
Intentional Overdose (10)
Somnolence (7)
Hallucination (7)
Agitation (7)
Fatigue (6)
Middle Insomnia (5)
Dizziness (5)
Headache (4)
Hallucination, Visual (4)
Feeling Abnormal (4)
Aggression (3)
Amnesia (3)
Coordination Abnormal (3)
Completed Suicide (3)
Somnambulism (3)
Mydriasis (2)
Malaise (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Sonata Side Effects Reported to FDA



Sonata Side Effect Report#9721139
Product Quality Issue
This is a report of a 88-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: sleep disorder,hypertension,blood cholesterol abnormal, who was treated with Sonata (dosage: 10 Mg, As Needed (one Or Two Tablet During Bed Time), start time: 2010), combined with:
  • Exforge (Amlodipine Besylate 10mg/ Valsartan 320mg, Daily)
  • Lipitor (20 Mg, Daily)
and developed a serious reaction and side effect(s): Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in female patients, resulting in Product Quality Issue side effect.
Sonata Side Effect Report#9215276
Intentional Overdose, Suicide Attempt, Depression
This report suggests a potential Sonata Intentional Overdose side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: insomnia,back pain,depression and used Sonata (dosage: 10 Mg, As Needed) starting 201210. After starting Sonata the patient began experiencing various side effects, including: Intentional Overdose, Suicide Attempt, DepressionAdditional drugs used concurrently:
  • Valium (5 Mg, As Needed)
  • Escitalopram (10 Mg, 1 In 1 Day (daily))
  • Escitalopram (20 Mg, 1 In 1 Day (daily))
The patient was hospitalized. Although Sonata demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intentional Overdose, may still occur.
Sonata Side Effect Report#9209424
Dizziness, Rash, Pruritus, Swelling Face, Swollen Tongue
This Dizziness problem was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sleep disorder. On
Mar 19, 2013 this consumer started treatment with Sonata (dosage: 10 Mg At Hs). The following drugs were being taken at the same time:
  • Benadryl
When using Sonata, the patient experienced the following unwanted symptoms/side effects: Dizziness, Rash, Pruritus, Swelling Face, Swollen TongueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Sonata Side Effect Report#9105996
Dry Eye, Eye Pain, Eye Infection
This Dry Eye side effect was reported by a health professional from US. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: insomnia,blood cholesterol increased,hormone level abnormal,hair growth abnormal,benign prostatic hyperplasia.The patient was prescribed Sonata (drug dosage: 10 Mg, 1x/day), which was initiated on 201212. Concurrently used drugs:
  • Lipitor (Unk)
  • Zoloft (Unk)
  • Finasteride (Unk)
  • Flomax (Unk)
  • Calcium (Unk)
.After starting to take Sonata the consumer reported adverse symptoms, such as: Dry Eye, Eye Pain, Eye InfectionThese side effects may potentially be related to Sonata.
Sonata Side Effect Report#9050413
Eye Pain, Vision Blurred, Toothache, Muscle Spasms, Photosensitivity Reaction, Pain, Eye Disorder
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: sleep disorder,insomnia,gastrooesophageal reflux disease,oesophagitis, who was treated with Sonata (dosage: 10 Mg, At Bedtime, start time: 201301), combined with: NA. and developed a serious reaction and side effect(s): Eye Pain, Vision Blurred, Toothache, Muscle Spasms, Photosensitivity Reaction, Pain, Eye Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in male patients, resulting in Eye Pain side effect.
Sonata Side Effect Report#8941646
Rapid Eye Movements Sleep Abnormal, Loss Of Dreaming, Fatigue
This report suggests a potential Sonata Rapid Eye Movements Sleep Abnormal side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: insomnia nos and used Sonata (dosage: 5 Mg, 1x/day) starting 201211. After starting Sonata the patient began experiencing various side effects, including: Rapid Eye Movements Sleep Abnormal, Loss Of Dreaming, FatigueAdditional drugs used concurrently: NA. Although Sonata demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rapid Eye Movements Sleep Abnormal, may still occur.
Sonata Side Effect Report#8756614
Hypersensitivity, Burning Sensation, Pruritus, Heart Rate Increased, Irritability
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sleep disorder. On
Aug 21, 2009 this consumer started treatment with Sonata (dosage: 10 Mg, 1x/day). The following drugs were being taken at the same time: NA. When using Sonata, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Burning Sensation, Pruritus, Heart Rate Increased, IrritabilityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Sonata Side Effect Report#8480793-7
Impaired Driving Ability, Depressed Level Of Consciousness, Somnambulism, Hallucination
This Impaired Driving Ability side effect was reported by a consumer or non-health professional from United States. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Sonata (drug dosage: 10 Mg Daily Po), which was initiated on
Jan 01, 2008. Concurrently used drugs:
  • Zaleplon (10 Mg Daily Po)
.After starting to take Sonata the consumer reported adverse symptoms, such as: Impaired Driving Ability, Depressed Level Of Consciousness, Somnambulism, HallucinationThese side effects may potentially be related to Sonata.
Sonata Side Effect Report#8212607-4
Dyspnoea, Chest Pain, Cholecystitis Chronic, Biliary Colic
This is a report of a 34-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Sonata (dosage: NA, start time:
Jan 01, 2008), combined with:
  • Yaz (Unk)
  • Ortho Tri-cyclen (Unk Unk, Qd)
and developed a serious reaction and side effect(s): Dyspnoea, Chest Pain, Cholecystitis Chronic, Biliary Colic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in female patients, resulting in Dyspnoea side effect. The patient was hospitalized.
Sonata Side Effect Report#8185075-9
Amnesia, Victim Of Sexual Abuse
This report suggests a potential Sonata Amnesia side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Sonata (dosage: Single) starting
Jan 01, 2008. After starting Sonata the patient began experiencing various side effects, including: Amnesia, Victim Of Sexual AbuseAdditional drugs used concurrently: NA. Although Sonata demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Amnesia, may still occur.
Sonata Side Effect Report#8171626-7
Hypoaesthesia, Nail Disorder, Dizziness, Fatigue, Influenza Like Illness
This Hypoaesthesia problem was reported by a consumer or non-health professional from United States. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 06, 2011 this consumer started treatment with Sonata (dosage: NA). The following drugs were being taken at the same time:
  • Lodine
  • Benlysta (10 Mg/kg, 1 In 2 Wk, Intravenous Drip)
  • Lexapro
  • Ultram
  • Plaquenil
When using Sonata, the patient experienced the following unwanted symptoms/side effects: Hypoaesthesia, Nail Disorder, Dizziness, Fatigue, Influenza Like IllnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoaesthesia, may become evident only after a product is in use by the general population.
Sonata Side Effect Report#8134191-6
Emotional Distress, Pain, Anxiety, Cholecystitis Chronic, Gallbladder Disorder, Injury, Bile Duct Obstruction
This Emotional Distress side effect was reported by a consumer or non-health professional from United States. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sonata (drug dosage: NA), which was initiated on
Jan 01, 2010. Concurrently used drugs:
  • Yaz (Unk)
  • Acetaminophen And Hydrocodone Bitartrate
  • Bisoprolol Fumarate (Daily)
  • Yasmin (Unk)
  • Levothyroxine Sodium (Daily)
  • Drospirenone And Ethinyl Estradiol (Unk)
  • Diphenoxylate (Daily)
.After starting to take Sonata the consumer reported adverse symptoms, such as: Emotional Distress, Pain, Anxiety, Cholecystitis Chronic, Gallbladder Disorder, Injury, Bile Duct ObstructionThese side effects may potentially be related to Sonata. The patient was hospitalized.
Sonata Side Effect Report#8093770-5
Contusion
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: insomnia,hypothyroidism,rheumatoid arthritis,hypomania, who was treated with Sonata (dosage: NA, start time: NS), combined with:
  • Thyroid Tab
  • Methotrexate
  • Lithium Carbonate
  • Hydrocortisone (Pills)
  • Effexor
  • Humira
and developed a serious reaction and side effect(s): Contusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in female patients, resulting in Contusion side effect.
Sonata Side Effect Report#8046235-0
Insulin Resistance, Vaginal Odour
This report suggests a potential Sonata Insulin Resistance side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: insomnia,fibromyalgia,blood cholesterol increased,dyspepsia and used Sonata (dosage: 10 Mg Daily) starting
Jan 01, 2010. After starting Sonata the patient began experiencing various side effects, including: Insulin Resistance, Vaginal OdourAdditional drugs used concurrently:
  • Lyrica (150 Mg, 4x/day)
  • Lovastatin (20 Mg Daily)
  • Calcium Carbonate (Unk)
  • Triazolam (0.25 Mg Daily)
Although Sonata demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Insulin Resistance, may still occur.
Sonata Side Effect Report#8029817-1
This Death problem was reported by a physician from United States. A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia,bipolar disorder. On
Jan 01, 2009 this consumer started treatment with Sonata (dosage: Unk). The following drugs were being taken at the same time:
  • Depakote (250 Mg, Unk)
  • Geodon (120 Mg, 2x/day)
When using Sonata, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Sonata Side Effect Report#7772714-7
Blood Cholesterol Increased, Diabetic Complication, Obesity, Hyperlipidaemia, Type 2 Diabetes Mellitus, Tooth Loss, Glycosuria, Blood Triglycerides Increased, Dermal Cyst
This Blood Cholesterol Increased side effect was reported by a health professional from United States. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sonata (drug dosage: NA), which was initiated on
Jan 01, 1995. Concurrently used drugs:
  • Benztropine Mesylate
  • Metronidazole
  • Ibuprofen
  • Gemfibrozil
  • Abilify
  • Paroxetine Hydrochloride
  • Levaquin
  • Seroquel
.After starting to take Sonata the consumer reported adverse symptoms, such as: Blood Cholesterol Increased, Diabetic Complication, Obesity, Hyperlipidaemia, Type 2 Diabetes Mellitus, Tooth Loss, Glycosuria, Blood Triglycerides Increased, Dermal CystThese side effects may potentially be related to Sonata.
Sonata Side Effect Report#7730356-3
Rash Pruritic, Scab
This is a report of a 36-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Sonata (dosage: NA, start time:
May 31, 2011), combined with:
  • Xanax
  • Lamictal (25mg Twice Per Day)
and developed a serious reaction and side effect(s): Rash Pruritic, Scab after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in male patients, resulting in Rash Pruritic side effect.
Sonata Side Effect Report#7723360-2
Feeling Jittery, Restless Legs Syndrome
This report suggests a potential Sonata Feeling Jittery side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: middle insomnia,cartilage atrophy and used Sonata (dosage: 5 Mg, Prn) starting
Apr 05, 2009. After starting Sonata the patient began experiencing various side effects, including: Feeling Jittery, Restless Legs SyndromeAdditional drugs used concurrently:
  • Glucosamine W/chondroitin Sulfate
Although Sonata demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Feeling Jittery, may still occur.
Sonata Side Effect Report#7712291-X
Amnesia, Victim Of Sexual Abuse
This Amnesia problem was reported by a physician from United States. A 24-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2008 this consumer started treatment with Sonata (dosage: Single). The following drugs were being taken at the same time: NA. When using Sonata, the patient experienced the following unwanted symptoms/side effects: Amnesia, Victim Of Sexual AbuseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Amnesia, may become evident only after a product is in use by the general population.
Sonata Side Effect Report#7524369-4
Dysphagia, Mycobacterium Avium Complex Infection, Gastrooesophageal Reflux Disease
This Dysphagia side effect was reported by a health professional from United States. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sonata (drug dosage: NA), which was initiated on
Nov 06, 2006. Concurrently used drugs:
  • Namenda
  • Tysabri
  • Baclofen
  • Citalopram
  • Klonopin
  • Actonel
  • Amitriptyline Hcl
  • Rozerem
.After starting to take Sonata the consumer reported adverse symptoms, such as: Dysphagia, Mycobacterium Avium Complex Infection, Gastrooesophageal Reflux DiseaseThese side effects may potentially be related to Sonata.
Sonata Side Effect Report#7273560-3
Coeliac Disease, Oesophagitis, Flatulence, Dyspepsia
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: insomnia,autoimmune thyroiditis, who was treated with Sonata (dosage: NA, start time:
Jan 01, 1979), combined with:
  • Levothyroxine
  • Synthroid
  • Ambien
and developed a serious reaction and side effect(s): Coeliac Disease, Oesophagitis, Flatulence, Dyspepsia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in female patients, resulting in Coeliac Disease side effect.
Sonata Side Effect Report#7258526-1
Oedema Peripheral, Abdominal Pain, Urine Output Decreased, Abdominal Distension, Colonic Polyp, Neck Pain, Nausea
This report suggests a potential Sonata Oedema Peripheral side effect(s) that can have serious consequences. A female patient (weight: NA) from was diagnosed with the following symptoms/conditions: NA and used Sonata (dosage: NA) starting
Jan 01, 2005. After starting Sonata the patient began experiencing various side effects, including: Oedema Peripheral, Abdominal Pain, Urine Output Decreased, Abdominal Distension, Colonic Polyp, Neck Pain, NauseaAdditional drugs used concurrently:
  • Humira
  • Lorazepam
Although Sonata demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oedema Peripheral, may still occur.
Sonata Side Effect Report#7257997-4
Incorrect Dose Administered, Injection Site Haemorrhage, Injection Site Pain
This Incorrect Dose Administered problem was reported by a consumer or non-health professional from United States. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia,psoriatic arthropathy. On
Jun 01, 2010 this consumer started treatment with Sonata (dosage: NA). The following drugs were being taken at the same time:
  • Humira
  • Ascorbic Acid
  • Flaxseed Oil
  • Evoxac
  • Calcium W/vitamin D
  • Vitamin E
  • Nexium
  • Neurontin (At Night)
When using Sonata, the patient experienced the following unwanted symptoms/side effects: Incorrect Dose Administered, Injection Site Haemorrhage, Injection Site PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Incorrect Dose Administered, may become evident only after a product is in use by the general population.
Sonata Side Effect Report#7103374-6
Poor Quality Sleep
This Poor Quality Sleep side effect was reported by a pharmacist from United States. A female patient (weight:NA) experienced the following symptoms/conditions: sleep disorder.The patient was prescribed Sonata (drug dosage: 5 Mg, Qhs, Prn), which was initiated on
Jul 21, 2008. Concurrently used drugs:
  • Vitamins (Unk)
.After starting to take Sonata the consumer reported adverse symptoms, such as: Poor Quality SleepThese side effects may potentially be related to Sonata.
Sonata Side Effect Report#7103099-7
Hallucination, Visual
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: insomnia, who was treated with Sonata (dosage: 10 Mg, Unk, start time: NS), combined with:
  • Birth Control
and developed a serious reaction and side effect(s): Hallucination, Visual after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sonata treatment in female patients, resulting in Hallucination, Visual side effect.


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The appearance of Sonata on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Sonata Side Effects for Women?

Women Side EffectsReports
Intentional Misuse 11
Agitation 7
Overdose 7
Suicide Attempt 7
Intentional Overdose 6
Somnolence 5
Fatigue 4
Feeling Abnormal 4
Hallucination 4
Hallucination, Visual 4

What are common Sonata Side Effects for Men?

Men Side EffectsReports
Intentional Overdose 4
Coordination Abnormal 3
Hallucination 3
Middle Insomnia 3
Overdose 3
Suicide Attempt 3
Aggression 2
Dizziness 2
Euphoric Mood 2
Eye Pain 2

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Sonata reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Sonata Side Effects

    Did You Have a Sonata Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Sonata for You?

    Exceeded Expectations
    Effective
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    Sonata Safety Alerts, Active Ingredients, Usage Information

    NDC54868-4431
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSonata
    Namezaleplon
    Dosage FormCAPSULE
    RouteORAL
    On market since20040401
    LabelerPhysicians Total Care, Inc.
    Active Ingredient(s)ZALEPLON
    Strength(s)10
    Unit(s)mg/1
    Pharma Classgamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depres

    Sonata Dosage, Warnings, Usage.

    Side Effects reported to FDA: 79

    Sonata safety alerts: 2007

    Reported deaths: 6

    Reported hospitalizations: 36

    Sonata (zaleplon)

    Audience: Healthcare professionals, consumers

    [Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.

    [March 14, 2007 - News Release - FDA]

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