Restoril

Risks from Concomitant Use with Opioids

• 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. 

• Increased risk of drug-related mortality from concomitant use with opioids. 

• Inform patients not to drive or operate heavy machinery until the effects of concomitant use with opioids have been determined.

Abuse, Misuse, and Addiction 

• Assess patient's risk for abuse, misuse, addiction prior to and during therapy.

• It is recommended to counsel patients about the risks and proper use of Restoril especially in those at elevated risk, along with monitoring for signs and symptoms of abuse, misuse, and addiction.

• Evaluate and institute early treatment if a substance use disorder is suspected.

Dependence and Withdrawal Reactions

• Gradually taper to discontinue Restoril or reduce dose. Increased risk for withdrawal adverse reactions in patients who take higher doses and those with longer durations of use.

• Acute Withdrawal Reactions: Abrupt discontinuation or rapid dose reduction after continued use, or administration of flumazenil may cause acute withdrawal reactions.

• Protracted Withdrawal Syndrome: In some cases, this syndrome has lasted weeks to more than 12 months. Reevaluate for the presence of primary psychiatric and/or medical illness if insomnia fails to remit after 7–10 days of use. Worsening insomnia may be due to unrecognized psychiatric or physical disorder. 

Behavioral Changes

• Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. This may occur when using Restoril alone at recommended doses; increased risk for complex behaviors when used with alcohol and other CNS depressants. Strongly consider discontinuing Restoril in patients who report a “sleep-driving” episode.

• The use of sedative/hypnotics in primarily depressed patients may worsen depression including suicidal thinking.

• Evaluate immediately if any new behavioral sign or symptom of concern occurs.

Severe Anaphylactic and Anaphylactoid Reactions

• Do not rechallenge in patients who develop angioedema after treatment with Restoril.

Neonatal Sedation and Withdrawal Syndrome

• Use late in pregnancy can cause sedation and/or withdrawal symptoms in the neonate. Monitor neonates exposed during pregnancy or labor for signs of sedation and monitor for signs of withdrawal.

General

• Caution in severely depressed patients or those in whom there is any evidence of latent depression.

• Caution in patients with renal or hepatic impairment. 

• Caution in patients with chronic pulmonary insufficiency.

• There has been 1 case of stillbirth at term reported 8 hours after a pregnant patient received Restoril and diphenhydramine; the cause and effect of this has not yet been established.