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The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • CNS-depressant effects and next-day impairment [see WARNINGS AND PRECAUTIONS]
  • Benzodiazepine withdrawal syndrome[see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking and behavior changes, and complex behaviors[see WARNINGS AND PRECAUTIONS]
  • Worsening of depression[see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of Doral. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.

  DORAL 15 mg PLACEBO
NUMBER OF PATIENTS 267 268
  % OF PATIENTS REPORTING
Central Nervous System
  Daytime Drowsiness 12 3
  Headache 5 2
  Fatigue 2 0
  Dizziness 2 < 1
Autonomic Nervous System
  Dry Mouth 2 < 1
Gastrointestinal System
  Dyspepsia 1 < 1

A double-blind, controlled sleep laboratory study (N=30) in elderly patients compared the effects of quazepam 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be well tolerated. Caution must be used in interpreting this data due to the small size of the study.