DORAL (Quazepam) is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Important Safety Information ▲ expand

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug Interactions (7)]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Doral can produce daytime impairment, and this risk increases with dose and concomitant use of other CNS depressants. If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness. Doral is contraindicated in patients with a known hypersensitivity to quazepam or other benzodiazepines, established or suspected sleep apnea, or chronic pulmonary insufficiency. Rare cases of severe anaphylactic reactions including angioedema and dyspnea have been reported. Complex behaviors, such as sleep driving or sleep eating, have been reported with the use of sedative-hypnotics. Immediately evaluate the onset of any new behavioral changes. Benzodiazepines may worsen depression, and appropriate precautions should be considered in at risk patients. For a full list of warnings and precautions, please refer to the full prescribing information.