No

Hypnotic, Miscellaneous

Short-term management of insomnia

C-IV

C

Porphyria; hypersensitivity to ethchlorvynol or any component

Administer with caution to depressed or suicidal patients or to patients with a history of drug abuse; intoxication symptoms may appear with prolonged daily doses of as little as 1 g; withdrawal symptoms may be seen upon abrupt discontinuation; use with caution in the elderly and in patients with hepatic or renal dysfunction; use with caution in patients who have a history of paradoxical restlessness to barbiturates or alcohol; some products may contain tartrazine

Cardiovascular: Hypotension, syncope

Central nervous system: Dizziness, facial numbness, mild hangover, excitement, ataxia, hysteria, prolonged hypnosis, mild stimulation, giddiness

Dermatologic: Rash, urticaria

Gastrointestinal: Indigestion, nausea, stomach pain, unpleasant aftertaste, vomiting

Hematologic: Thrombocytopenia

Hepatic: Cholestatic jaundice

Neuromuscular & skeletal: Weakness (severe)

Ocular: Blurred vision

Symptoms of overdose include prolonged deep coma, respiratory depression, hypothermia, bradycardia, hypotension, nystagmus

Treatment is supportive in nature; hemoperfusion may be helpful in enhancing elimination

Increased toxicity (CNS depression) with alcohol, CNS depressants

May inhibit the hypoprothrombinemic response to warfarin via an unknown mechanism; monitor for altered anticoagulant effect or consider using a benzodiazepine

Capsules should not be crushed and should not be refrigerated

Unknown; causes nonspecific depression of the reticular activating system

Onset of action: 15-60 minutes

Duration: 5 hours

Absorption: Rapid from GI tract

Metabolism: In the liver

Half-life: 10-20 hours

Time to peak serum concentration: 2 hours

Adults: Oral: 500-1000 mg at bedtime

Alcohol: Additive CNS effect, avoid use

Cardiac and respiratory function and abuse potential

Therapeutic: 2-9 mg/mL; Toxic: >20 mg/mL

No information available to require special precautions

No effects or complications reported

Use exactly as directed (do not increase dose or frequency or discontinue without consulting prescriber); may cause physical and/or psychological dependence. While using this medication, do not use alcohol or other prescription or OTC medications (especially, pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or nausea, vomiting, unpleasant taste (small frequent meals, good mouth care, chewing gum, or sucking lozenges may help). Report rash or skin irritation, CNS changes (confusion, depression, increased sedation, excitation, headache, abnormal thinking, insomnia, or nightmares), muscle pain or weakness, difficulty breathing, chest pain or palpitations, yellow skin or change in color of urine or stool, or ineffectiveness of medication. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Raise bed rails, institute safety measures, assist with ambulation

Capsule: 200 mg, 500 mg, 750 mg

Bertino JS Jr and Reed MD, "Barbiturate and Nonbarbiturate Sedative Hypnotic Intoxication in Children," Pediatr Clin North Am, 1986, 33(3):703-22.

Kathpalia SC, Haslitt JH, and Lim VS, "Charcoal Hemoperfusion for Treatment of Ethchlorvynol Overdose," Artif Organs, 1983, 7(2):246-8.

Kelner MJ and Bailey DN, "Ethchlorvynol Ingestion: Interpretation of Blood Concentrations and Clinical Findings," J Toxicol Clin Toxicol, 1983-84, 21(3):399-408.

Yell RP, "Ethchlorvynol Overdose," Am J Emerg Med, 1990, 8(3):246-50.