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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