Sleep-wake disorders:

Indications for: RESTORIL

Short-term (7–10 days) treatment of insomnia.

Clinical Trials:

  • The approval of Restoril was based on 2 week, placebo-controlled sleep laboratory studies in patients with chronic insomnia. Patients received either Restoril 7.5 mg, 15 mg, 30 mg, or placebo give 30 minutes before bedtime.

  • Results showed a linear dose-response improvement in total sleep time and sleep latency, with significant drug-placebo differences at 2 weeks occurring only for total sleep time at the 2 higher doses, and for sleep latency only at the highest dose. 

  • REM sleep was essentially unchanged and slow wave sleep was decreased.

  • There was no evidence of tolerance development in sleep parameters.

  • There was a linear dose-response improvement in total sleep time, sleep latency and number of awakenings, with significant drug-placebo differences occurring for sleep latency at all doses, for total sleep time at the 2 higher doses and for number of awakenings only at the 30 mg dose.

Adult Dosage:

Use lowest effective dose. Usual dose: 7.5mg–30mg at bedtime. Elderly or debilitated: initially 7.5mg.

Children Dosage:

Not established.

Boxed Warning:

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

RESTORIL 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. Chronic pulmonary insufficiency. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Write ℞ for smallest practical amount. Renal or hepatic impairment. 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.

RESTORIL Classification:

Benzodiazepine.

RESTORIL 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. Additive CNS depressant effects with alcohol, other CNS depressants.

Adverse Reactions:

Drowsiness, headache, fatigue, nervousness, lethargy, dizziness, nausea, hangover; CNS effects, complex behaviors (eg, sleep-driving), anaphylaxis, angioedema, withdrawal reactions.

Metabolism:

Conjugation. 

Drug Elimination:

Renal (80–90%). Half-life: 3.5–18.4 hours.

Generic Drug Availability:

YES

How Supplied:

Caps 7.5mg—30, 100; 22.5mg—30; 15mg, 30mg—100