Important Safety Imformation (ISI)
Doral is contraindicated in patients with known hypersensitivity to Doral or other benzodiazepines, established or suspected sleep apnea, or pulmonary insufficiency. Doral can produce CNS depressant effects, including daytime impairment. Patients should be cautioned against driving and other activities requiring complete mental alertness. There is an increased risk of next-day psychomotor impairment if Doral is taken with less than a full night of sleep remaining (7-8 hours). The use of Doral and concomitant CNS depressants may require downward dose adjustment and the concomitant use of Doral with other sleep-hypnotics is not recommended. If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness. Rare cases of severe anaphylactic reactions including angioedema involving the tongue, glottis or larynx and dyspnea have been reported after treatment with Doral and are potentially fatal. Patients experiencing an anaphylactic or anaphylactoid reaction should be treated in an emergency department and should not be rechallenged. Behavior changes and complex behaviors such as “sleep driving” and “sleep eating” can occur with the use of sleep-hypnotics, and Doral should be discontinued if these symptoms occur. Benzodiazepines may worsen depression and consequently, appropriate precautions (e.g., increased monitoring, limiting prescription size) should be considered. Avoid abrupt discontinuation in at-risk patients of benzodiazepine withdrawal syndrome, particularly patients taking higher than recommended doses over an extended time. The most common adverse reactions (>1%) observed with Doral were drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia. Doral is classified as a Schedule IV controlled substance and patients treated with Doral should be monitored for tolerance, abuse, and dependence. For a full list of warnings and precautions, please refer to the full prescribing information.