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: 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 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 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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