WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS. See full prescribing information for complete boxed warning.
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. 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 (5.1, 7).
- The use of benzodiazepines, including DORAL®, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing DORAL® and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (5.2).
- Abrupt discontinuation or rapid dosage reduction of DORAL® after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue DORAL® or reduce the dosage (2.3, 5.3).
DORAL® is contraindicated in patients with known hypersensitivity to DORAL® or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of DORAL®. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should be treated in an emergency department and should not be rechallenged with DORAL®.
DORAL® is contraindicated in patients with established or suspected sleep apnea, or with pulmonary insufficiency.
WARNINGS AND PRECAUTIONS
CNS-Depressant Effects and Daytime Impairment: Doral® can produce CNS depressant effects, including daytime impairment. Patients should be cautioned against driving and other activities requiring complete mental alertness. Alcohol generally should not be used during treatment with DORAL®. Additive effects occur with concomitant use of other CNS depressants. There is an increased risk of next-day psychomotor impairment if higher than the recommended dose is taken, if co-administered with other CNS depressants, or if 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.
Because DORAL® can cause drowsiness and a decreased level of consciousness, patients particularly the elderly, are at higher risk of falls.
Need to Evaluate for Co-morbid Diagnoses: If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness that should be evaluated.
Abnormal Thinking and Behavior Changes: Abnormal thinking, behavior changes, and complex behaviors such as “sleep driving” (i.e., driving while not fully awake, with amnesia for the event) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Some of these changes include decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), bizarre behavior, and depersonalization. Visual and auditory hallucinations have also been reported. Doral® should be discontinued if these symptoms occur.
Worsening of Depression: Benzodiazepines may worsen depression and consequently, appropriate precautions (e.g., increased monitoring for suicidal ideation, limiting prescription size) should be considered.
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.
DORAL® contains quazepam, a Schedule IV controlled substance.