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Doral

What is insomnia?

Insomnia is defined as difficulty initiating or maintaining sleep, or both, despite adequate opportunity and time to sleep, leading to impaired daytime functioning. Insomnia may be due to poor quality or quantity of sleep.

Insomnia is very common and occurs in 30% to 50% of the general population. Approximately 10% of the population may suffer from chronic (long-standing) insomnia.

Insomnia affects people of all ages including children, although it is more common in adults and its frequency increases with age. In general, women are affected more frequently than men.

Insomnia may be divided into three classes based on the duration of symptoms.

  • Insomnia lasting one week or less may be termed transient insomnia;
  • short-term insomnia lasts more than one week but resolves in less than three weeks; and
  • long-term or chronic insomnia lasts more than three we...

Doral

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OVERDOSE

Manifestations of overdosage seen with other benzodiazepines include somnolence, confusion, and coma. In the event that an overdose occurs, the following is the recommended treatment. Respiration, pulse, and blood pressure should be monitored, as in all cases of drug overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be treated with the use of norepinephrine bitartrate or metaraminol bitartrate. Dialysis is of limited value. Animal experiments suggest that forced diuresis or hemodialysis are probably of little value in treating overdosage. As with the management of intentional overdosing with any drug, it should be borne in mind that multiple agents may have been ingested.

The oral LD50 in mice was greater than 5000 mg/kg.

CONTRAINDICATIONS

DORAL® (quazepam tablets) Tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines, and in patients with established or suspected sleep apnea.

Usage in Pregnancy

Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.

DORAL® (quazepam tablets) Tablets are contraindicated in pregnancy because the potential risks outweigh the possible advantages of their use during this period. If there is a likelihood of the patient becoming pregnant while receiving DORAL® (quazepam tablets) , she should be warned of the potential risk to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of child-bearing potential may be pregnant at the time of institution of therapy should be considered. (see Pregnancy, Teratogenic Effects: Pregnancy Category X).

Last reviewed on RxList: 4/30/2010
This monograph has been modified to include the generic and brand name in many instances.

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