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Sonata (Zaleplon) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sonata (Zaleplon) 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 (18)
Death (3)

Reports by Reaction Type

Drug Ineffective (5)Death (3)Insomnia (3)Drug Screen False Positive (2)Victim of Sexual Abuse (1)Pruritus (1)Urticaria (1)Blood Thyroid Stimulating Hormone Increased (1)Erythema (1)Poor Quality Sleep (1)Fatigue (1)Vaginal Odour (1)

Possible Sonata 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:
Acetaminophen
    Dosage: unk
    Indication: Insomnia

Ambien
    Dosage: unk
    Indication: Insomnia

Cytomel
    Dosage: unk
    Administration route: Oral
    Indication: Hypothyroidism

Lunesta
    Dosage: unk
    Indication: Insomnia

Sonata
    Dosage: unk
    Indication: Insomnia

Synthroid
    Dosage: 75 ug, unk
    Administration route: Oral
    Indication: Hypothyroidism

Synthroid
    Dosage: unk
    Administration route: Oral



Possible Sonata side effects in female

Reported by a physician from United States on 2012-06-29

Patient: female

Reactions: Drug Ineffective, Insomnia

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in 28 year old female

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: 28 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Impaired Driving Ability, Depressed Level of Consciousness, Somnambulism, Hallucination

Drug(s) suspected as cause:
Sonata
    Dosage: 10 mg daily po
    Administration route: Oral
    Indication: Insomnia
    Start date: 2007-01-01
    End date: 2007-12-31

Zaleplon
    Dosage: 10 mg daily po
    Administration route: Oral
    Indication: Insomnia
    Start date: 2008-01-01
    End date: 2008-12-01



Possible Sonata side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female

Reactions: Poor Quality Sleep, Insomnia

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Drug Screen False Positive

Drug(s) suspected as cause:
Sonata

Other drugs received by patient: Suboxone; Lunesta; Suboxone



Possible Sonata side effects in 84 year old male

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 84 year old male

Reactions: Middle Insomnia, Tachyphrenia, Drug Ineffective, Abnormal Behaviour

Drug(s) suspected as cause:
Lunesta
    Dosage: 3 mg, unk
    Indication: Sleep Disorder
    Start date: 2010-01-01

Lunesta
    Dosage: 6 mg, unk
    Indication: Insomnia

Sonata
    Dosage: 30mg, 1x/day
    Administration route: Oral

Zolpidem
    Dosage: 30 mg, unk
    Administration route: Oral
    Indication: Insomnia



Possible Sonata side effects in 24 year old female

Reported by a physician from United States on 2012-03-05

Patient: 24 year old female

Reactions: Victim of Sexual Abuse, Amnesia

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-02

Patient: female

Reactions: Fatigue, Dizziness

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-02

Patient: female

Reactions: Dysphagia

Drug(s) suspected as cause:
Omeprazole
    Dosage: unk

Sonata
    Dosage: unk



Possible Sonata side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-02

Patient: female, weighing 83.9 kg (184.6 pounds)

Reactions: Pruritus, Urticaria, Erythema, Pallor

Drug(s) suspected as cause:
Sonata
    Dosage: unk
    Administration route: Oral
    Start date: 2011-03-08
    End date: 2011-03-08

Sonata
    Dosage: unk
    Administration route: Oral
    Start date: 2011-03-03
    End date: 2011-03-03

Sonata
    Dosage: unk
    Start date: 2011-03-03
    End date: 2011-03-08

Velcade
    Dosage: unk
    Start date: 2011-02-10
    End date: 2011-03-03

Velcade
    Dosage: unk
    Start date: 2011-03-08

Velcade
    Dosage: unk
    Indication: Multiple Myeloma
    Start date: 2008-01-01
    End date: 2008-01-01

Other drugs received by patient: Decadron; Decadron



Possible Sonata side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: male, weighing 90.7 kg (199.5 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Sonata
    Dosage: 10 mg, as needed
    Administration route: Oral
    Indication: Insomnia

Zaleplon
    Dosage: 10 mg, as needed
    Administration route: Oral

Zaleplon
    Dosage: 10 mg, as needed
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-08-16

Other drugs received by patient: Levothyroxine; Adderall 5; Levothyroxine; Calcium; Fish OIL



Possible Sonata side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-09

Patient: male

Reactions: Drug Dependence

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-19

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-19

Patient: male, weighing 68.0 kg (149.7 pounds)

Reactions: Drug Screen False Positive

Drug(s) suspected as cause:
Sonata



Possible Sonata side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-13

Patient: female, weighing 68.9 kg (151.6 pounds)

Reactions: Vaginal Odour, Insulin Resistance

Drug(s) suspected as cause:
Lovastatin
    Dosage: 20 mg daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Lyrica
    Dosage: 150 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2010-01-01

Sonata
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Insomnia
    Start date: 2010-01-01

Triazolam
    Dosage: 0.25 mg daily
    Administration route: Oral
    Indication: Insomnia
    Start date: 2010-01-01

Other drugs received by patient: Calcium Carbonate



Possible Sonata side effects in 45 year old male

Reported by a physician from United States on 2012-01-10

Patient: 45 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakote
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Geodon
    Dosage: 120 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-01

Sonata
    Dosage: unk
    Administration route: Oral
    Indication: Sleep Disorder



Possible Sonata side effects in 45 year old male

Reported by a physician from United States on 2012-01-10

Patient: 45 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakote
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Geodon
    Dosage: 120 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-01

Sonata
    Dosage: unk
    Administration route: Oral
    Indication: Sleep Disorder



Possible Sonata side effects in 45 year old male

Reported by a physician from United States on 2012-01-09

Patient: 45 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakote
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Geodon
    Dosage: 120 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-01

Sonata
    Dosage: unk
    Administration route: Oral
    Indication: Insomnia

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