May cause CNS depression. Postmarketing studies indicated that use of hypnotic/sedative agents for sleep has been associated with hypersensitivity reactions including anaphylaxis as well as angioedema. May cause paradoxical responses, including agitation and hyperactivity, particularly in acute pain, chronic pain and pediatric patients. Increased risk for hazardous sleep-related activities such as sleep-driving; cooking and eating food, and making phone calls while asleep also noted. Use with caution in cardiovascular disease (may cause hypotension), in depression or suicidal tendencies, and in history of drug abuse or acute alcoholism (risk of drug dependency). Tolerance, psychological and physical dependence may occur with prolonged use. Use with caution in hepatic/renal impairment, and in respiratory disease (may cause respiratory depression). Effects may be potentiated when used with other sedative drugs or ethanol. Use with caution in the elderly, and in children. Abrupt cessation may precipitate withdrawal symptoms, including status epilepticus in epileptic patients.