About Doral®

DoralRX bottle
What is Doral®?

Doral® is a prescription sleep medicine indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Why Doral®?

Doral® is a medication for insomnia that helps with all three important components of sleep:1

  • Difficulty Falling Asleep (DFA)
  • Difficulty Staying Asleep (DSA)
  • Early Morning Awakening (EMA)

Doral® was proven effective in clinical studies for acute and chronic insomnia.1,2,3,4

How Doral® helps with Difficulty Falling Asleep?1,2,3,4,5

In clinical studies, Doral® was effective in:

  • Significantly increasing total sleep time and percent sleep time
  • Decreasing sleep latency and total wake time

How Doral® helps with Difficulty Staying Asleep?1,2,3,4,5

Doral’s unique pharmacokinetic profile helps patients with symptoms of frequent nocturnal awakening by:

  • Decreasing the number of nocturnal awakenings
  • Decreasing wake time after sleep onset

How Doral® helps with Early Morning Awakening?1,2,3,4,5

In clinical studies, Doral® was effective in:

  • Reducing wake time
  • Increase percent sleep time

Doral® 15mg starts working with first dose of administration. Recommended initial dose is 7.5mg. Split the 15 mg tablet along the score line to achieve 7.5 mg dose.

Doral® was also proven effective in a double-blind, controlled sleep lab study (N = 30) in elderly patients over a period of 7 days.

The main adverse events seen with Doral® during clinical trials are daytime drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia. Adverse events are dose related and can have additive effects when used with other CNS depressants, including alcohol. Complex sleep-related behaviors (e.g. sleep-driving with accompanying amnesia) have been reported with the use of sedative-hypnotics.

These behaviors can occur with initial treatment or in patients tolerant of Doral® or other sedative-hypnotics. Elderly and debilitated patients may be more sensitive to benzodiazepines, so caution is advised in their use. Avoid abrupt discontinuation in at-risk patients of benzodiazepine withdrawal syndrome, particularly patients taking higher than recommended doses over an extended time.


References:
  1. Doral® [package insert]. Atlanta, GA: Galt Pharmaceuticals; 2017.
  2. Kales A, Bixler EO, Soldatos CR, Vela-bueno A, Jacoby JA, Kales JD. Quazepam and temazepam: effects of short- and intermediate-term use and withdrawal. Clin Pharmacol Ther. 1986;39(3):345-52.
  3. Kales A, Bixler EO, Vela-bueno A, Soldatos CR, Niklaus DE, Manfredi RL. Comparison of short and long half-life benzodiazepine hypnotics: triazolam and quazepam. Clin Pharmacol Ther. 1986;40(4):378-86.
  4. Kales A, Bixler EO, Soldatos CR, Vela-bueno A, Jacoby J, Kales JD. Quazepam and flurazepam: long-term use and extended withdrawal. Clin Pharmacol Ther. 1982;32(6):781-8.
  5. Mendels J. Evaluation of the safety and efficacy of quazepam for the treatment of insomnia in psychiatric outpatients. J Clin Psychiatry. 1994;55(2):60-5.


Indications

DORAL® (Quazepam) is indicated for the treatment of insomnia characterized by difficulty 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.


What Pharmacies Carry Doral®?

Doral® is available at many independent and retail pharmacies. If you are unable to find this product locally, Sterling Specialty Pharmacy is able to mail to patients across the US.

Should your healthcare provider choose to prescribe Doral®, click here to download an information sheet to give to them.

E-scribe #: 2433693
Pharmacy Name: Sterling Specialty Pharmacy, Mendota Heights, MN
Phone Number: 888-618-4126
Fax Number: 866-588-0371



Important Safety Information ▲ expand
Indications & Usage ▲ expand

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).

CONTRAINDICATIONS

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.

 

ADVERSE REACTIONS

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.