DORAL SIDE EFFECTS
- Generic Name: quazepam tablets
- Brand Name: Doral
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- CNS-depressant effects and next-day impairment.
- Benzodiazepine withdrawal syndrome.
- Abnormal thinking and behavior changes, and complex behaviors.
- Worsening of depression.
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 practice. The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of DORAL.
| NUMBER OF PATIENTS | DORAL 15 mg | PLACEBO |
| 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 DORAL 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.
SRC: NLM .