Important Safety Imformation (ISI)

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
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 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.



Indications And Usage

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

The effectiveness of DORAL has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of DORAL has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of DORAL Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.


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