Drug information for ZALEPLON
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
ROXANE
77237
2008-07-01 Other Important Information from FDA
2005-11-18 Letter
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
ROXANE
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
MYLAN
77238
2008-07-01 Other Important Information from FDA
2008-06-09 Letter
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
MYLAN
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
TEVA PHARMS
77239
2008-07-14 Label
2008-07-01 Other Important Information from FDA
2008-06-10 Letter
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
TEVA PHARMS
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
CIPLA LTD
77505
2008-07-01 Other Important Information from FDA
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
CIPLA LTD
"
CAPSULE; ORAL
10MG
Discontinued
ZALEPLON
zaleplon
SANDOZ
78095
2008-07-01 Healthcare Professional Sheet
2008-06-10 Letter
CAPSULE; ORAL
5MG
Discontinued
ZALEPLON
zaleplon
SANDOZ
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
WEST WARD
78147
2009-01-06 Other Important Information from FDA
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
WEST WARD
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
UPSHER SMITH
78706
2008-07-01 Other Important Information from FDA
2008-06-10 Letter
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
UPSHER SMITH
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
AUROBINDO PHARMA
78829
2008-07-01 Other Important Information from FDA
2008-06-10 Letter
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
Quaternary Ammonium Compounds
AUROBINDO PHARMA
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
UNICHEM
78989
2008-07-01 Other Important Information from FDA
2008-06-10 Letter
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
UNICHEM
"
CAPSULE; ORAL
10MG
Prescription
AB
ZALEPLON
zaleplon
ORCHID HLTHCARE
90374
CAPSULE; ORAL
5MG
Prescription
AB
ZALEPLON
zaleplon
ORCHID HLTHCARE
"
Drug Adverse Effects information for ZALEPLON
Role code
Indications
Reaction
# Reports
PS
INSOMNIA
DRUG INEFFECTIVE
3
PS
INSOMNIA
INSOMNIA
2
SS
DEPRESSION
DRUG INEFFECTIVE
7
SS
DEPRESSION
FRONTOTEMPORAL DEMENTIA
7
SS
MAJOR DEPRESSION
DRUG INEFFECTIVE
2
SS
MAJOR DEPRESSION
FRONTOTEMPORAL DEMENTIA
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INEFFECTIVE
5
SS
PRODUCT USED FOR UNKNOWN INDICATION
FRONTOTEMPORAL DEMENTIA
5
C
CARDIAC ENZYMES INCREASED
CARDIOGENIC SHOCK
4
C
CARDIAC ENZYMES INCREASED
CONGESTIVE CARDIOMYOPATHY
4
C
CARDIAC ENZYMES INCREASED
RESPIRATORY FAILURE
4
C
CATAPLEXY
ACCIDENTAL OVERDOSE
1
C
CATAPLEXY
APNOEA
1
C
CATAPLEXY
DEHYDRATION
2
C
CATAPLEXY
DRUG INEFFECTIVE
1
C
CATAPLEXY
DRY EYE
2
C
CATAPLEXY
DYSSTASIA
1
C
CATAPLEXY
FALL
1
C
CATAPLEXY
MENTAL STATUS CHANGES
2
C
CATAPLEXY
MULTIPLE DRUG OVERDOSE
1
C
CATAPLEXY
MUSCULAR WEAKNESS
2
C
CATAPLEXY
OVERDOSE
1
C
CATAPLEXY
RESPIRATORY ARREST
1
C
CONTRACEPTION
CHOLECYSTITIS CHRONIC
2
C
CONTRACEPTION
CHOLELITHIASIS
2
C
CONTRACEPTION
GALLBLADDER DISORDER
2
C
CONTRACEPTION
PAIN
2
C
CROHN'S DISEASE
ASCITES
1
C
CROHN'S DISEASE
ATELECTASIS
1
C
CROHN'S DISEASE
BLOOD GLUCOSE INCREASED
1
C
CROHN'S DISEASE
BLOOD POTASSIUM DECREASED
1
C
CROHN'S DISEASE
CATHETER SITE HAEMORRHAGE
1
C
CROHN'S DISEASE
CHOLELITHIASIS
1
C
CROHN'S DISEASE
CULTURE WOUND POSITIVE
1
C
CROHN'S DISEASE
CYST
1
C
CROHN'S DISEASE
HAEMOGLOBIN DECREASED
1
C
CROHN'S DISEASE
HAEMORRHAGE SUBCUTANEOUS
1
C
CROHN'S DISEASE
PLATELET COUNT DECREASED
1
C
CROHN'S DISEASE
PLEURAL EFFUSION
1
C
CROHN'S DISEASE
PNEUMOPERITONEUM
1
C
CROHN'S DISEASE
PYREXIA
1
C
CROHN'S DISEASE
RED BLOOD CELL COUNT DECREASED
1
C
CROHN'S DISEASE
WHITE BLOOD CELL COUNT INCREASED
1
C
FIBROMYALGIA
ACCIDENTAL OVERDOSE
1
C
FIBROMYALGIA
APATHY
1
C
FIBROMYALGIA
APNOEA
1
C
FIBROMYALGIA
DEHYDRATION
2
C
FIBROMYALGIA
DEPRESSION
1
C
FIBROMYALGIA
DRUG INEFFECTIVE
1
C
FIBROMYALGIA
DRY EYE
2
C
FIBROMYALGIA
DYSSTASIA
1
C
FIBROMYALGIA
EMOTIONAL POVERTY
1
C
FIBROMYALGIA
FALL
1
C
FIBROMYALGIA
INSOMNIA
1
C
FIBROMYALGIA
MENTAL STATUS CHANGES
2
C
FIBROMYALGIA
MULTIPLE DRUG OVERDOSE
1
C
FIBROMYALGIA
MUSCULAR WEAKNESS
2
C
FIBROMYALGIA
OVERDOSE
1
C
FIBROMYALGIA
RESPIRATORY ARREST
1
C
FIBROMYALGIA
SEDATION
1
C
FIBROMYALGIA
SOMNAMBULISM
1
C
FIBROMYALGIA
SOMNOLENCE
1
C
FIBROMYALGIA
SPINAL DISORDER
1
C
FIBROMYALGIA
WEIGHT DECREASED
1
C
INSOMNIA
APATHY
1
C
INSOMNIA
DEPRESSION
1
C
INSOMNIA
EMOTIONAL POVERTY
1
C
INSOMNIA
INSOMNIA
1
C
INSOMNIA
SEDATION
1
C
INSOMNIA
SOMNAMBULISM
1
C
INSOMNIA
SOMNOLENCE
1
C
INSOMNIA
SPINAL DISORDER
1
C
INSOMNIA
WEIGHT DECREASED
1
C
MIDDLE INSOMNIA
APATHY
1
C
MIDDLE INSOMNIA
DEPRESSION
1
C
MIDDLE INSOMNIA
EMOTIONAL POVERTY
1
C
MIDDLE INSOMNIA
INSOMNIA
1
C
MIDDLE INSOMNIA
SEDATION
1
C
MIDDLE INSOMNIA
SOMNAMBULISM
1
C
MIDDLE INSOMNIA
SOMNOLENCE
1
C
MIDDLE INSOMNIA
SPINAL DISORDER
1
C
MIDDLE INSOMNIA
WEIGHT DECREASED
1
C
PREMENSTRUAL SYNDROME
CHOLECYSTITIS CHRONIC
2
C
PREMENSTRUAL SYNDROME
CHOLELITHIASIS
2
C
PREMENSTRUAL SYNDROME
GALLBLADDER DISORDER
2
C
PREMENSTRUAL SYNDROME
PAIN
2
C
PRODUCT USED FOR UNKNOWN INDICATION
ACCIDENTAL OVERDOSE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
APATHY
2
C
PRODUCT USED FOR UNKNOWN INDICATION
APNOEA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
CARDIOGENIC SHOCK
40
C
PRODUCT USED FOR UNKNOWN INDICATION
CONGESTIVE CARDIOMYOPATHY
40
C
PRODUCT USED FOR UNKNOWN INDICATION
DEHYDRATION
4
C
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INEFFECTIVE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DRY EYE
4
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSSTASIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
EMOTIONAL POVERTY
2
C
PRODUCT USED FOR UNKNOWN INDICATION
FALL
2
C
PRODUCT USED FOR UNKNOWN INDICATION
INSOMNIA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
MENTAL STATUS CHANGES
4
C
PRODUCT USED FOR UNKNOWN INDICATION
MULTIPLE DRUG OVERDOSE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
MUSCULAR WEAKNESS
4
C
PRODUCT USED FOR UNKNOWN INDICATION
OVERDOSE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
RESPIRATORY ARREST
2
C
PRODUCT USED FOR UNKNOWN INDICATION
RESPIRATORY FAILURE
40
C
PRODUCT USED FOR UNKNOWN INDICATION
SEDATION
2
C
PRODUCT USED FOR UNKNOWN INDICATION
SOMNAMBULISM
2
C
PRODUCT USED FOR UNKNOWN INDICATION
SOMNOLENCE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
SPINAL DISORDER
2
C
PRODUCT USED FOR UNKNOWN INDICATION
WEIGHT DECREASED
2
C
PULMONARY ARTERIAL HYPERTENSION
BLOOD CULTURE POSITIVE
1
C
PULMONARY ARTERIAL HYPERTENSION
DEATH
1
C
PULMONARY ARTERIAL HYPERTENSION
DYSPNOEA
1
C
PULMONARY ARTERIAL HYPERTENSION
INTERSTITIAL LUNG DISEASE
1
C
PULMONARY ARTERIAL HYPERTENSION
RENAL FAILURE ACUTE
1
C
PULMONARY ARTERIAL HYPERTENSION
STAPHYLOCOCCUS TEST POSITIVE
1
C
TYPE 2 DIABETES MELLITUS
PANCREATITIS
1
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