DORAL

Doral Generic Name & Formulations

Legal Class

CIV

General Description

Quazepam 15mg; scored tabs.

Pharmacological Class

Benzodiazepine.

How Supplied

Tabs—30, 100

Manufacturer

Galt Pharmaceuticals

Generic Availability

Mechanism of Action

Quazepam like other central nervous system agents of the 1,4-benzodiazepine class, presumably exerts its effects by binding to stereospecific receptors at several sites within the central nervous system. The exact mechanism of action is unknown.

Doral Indications

Indications

Insomnia.

Doral Dosage and Administration

Adult

Use lowest effective dose. Initially 7.5mg at bedtime; may increase to 15mg if needed.

Children

Not established.

Doral Contraindications

Contraindications

Sleep apnea. Pulmonary insufficiency.

Doral Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Doral Warnings/Precautions

Warnings/Precautions

Increased risk of drug-related mortality from concomitant use with opioids. Risk of CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses before initiation. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Abnormal thinking and behavioral changes. Write ℞ for smallest practical amount. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Elderly (higher risk of falls). Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

Doral Pharmacokinetics

Absorption

Doral is well absorbed from the gastrointestinal tract; absorption half-life is ~30 minutes. Peak plasma concentration occurs at about 2 hours and is ~20 ng/mL after a 15mg dose.

Distribution

Plasma protein bound: >95%.

Metabolism

Hepatic.

Elimination

Renal (31%), fecal (23%). Half-life: 39 hours.

Doral Interactions

Interactions

Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Concomitant other sedative/hypnotics: not recommended. Additive CNS depressant effects with alcohol, other CNS depressants (eg, other benzodiazepines, TCAs, psychotropics, anticonvulsants, antihistamines); consider dose reductions.

Doral Adverse Reactions

Adverse Reactions

Drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia; CNS effects, complex behaviors (eg, sleep-driving), anaphylaxis, angioedema; withdrawal reactions.

Doral Clinical Trials

See Literature

Doral Note

Not Applicable

Doral Patient Counseling