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 the only branded medication for Insomnia that helps with all three important components of sleep:

  • Difficulty Falling Asleep
  • Difficulty Staying Asleep
  • Early Morning Awakening

Doral was proven effective in clinical studies for acute and chronic insomnia

How Doral helps with Difficulty Falling Asleep?

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?

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?

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.


Indication

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

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 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.