Sleep-wake disorders:

Indications for: DORAL


Adult Dosage:

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

Children Dosage:

Not established.

DORAL Contraindications:

Sleep apnea. Pulmonary insufficiency.

Boxed Warning:

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

DORAL 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 Classification:


DORAL 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.

Adverse Reactions:

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



Drug Elimination:

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

Generic Drug Availability:


How Supplied:

Tabs—30, 100