Zaleplon

Hypnotics/sedatives have been associated with abnormal thinking and behavior changes including decreased inhibition, aggression, bizarre behavior, agitation, hallucinations, and depersonalization. These changes may occur unpredictably and may indicate previously unrecognized psychiatric disorders; evaluate appropriately.

May cause CNS depression impairing physical and mental capabilities; patients must be cautioned about performing tasks which require mental alertness (operating machinery or driving); an increased risk of next-day psychomotor impairment may also occur. Additive CNS-depressant effects may also occur if a higher than recommended dose is taken and/or if coadministered with other CNS depressants. Dose adjustment may be necessary if taking concomitant CNS depressants; use with alcohol is not recommended.

Hypersensitivity reactions, including anaphylaxis, as well as angioedema have been reported. Do not rechallenge patient if such reactions occur.

An increased risk for hazardous sleep-related activities such as sleep-driving, cooking and eating food, having sex, and making phone calls while asleep have been noted; amnesia may also occur. The use of alcohol, other CNS depressants, and exceeding the recommended maximum dose may increase the risk of these activities. Discontinue treatment in patients who report any sleep-driving episodes. Disease-related concerns:

Use with caution in patients with depression; worsening of depression, including suicide or suicidal ideation, has been reported with the use of hypnotics. Intentional overdose may be an issue in this population. The minimum dose that will effectively treat the individual patient should be used. Prescriptions should be written for the smallest quantity consistent with good patient care.

Use with caution in patients with a history of drug dependence, benzodiazepine abuse, or benzodiazepine-like hypnotic abuse.

Use with caution in patients with hepatic impairment; dosage adjustment recommended in mild to moderate impairment. Use is not recommended in patients with severe impairment.

Use with caution in patients with respiratory compromise, COPD, or sleep apnea. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use with caution in debilitated patients; potential for oversedation, impaired coordination, and confusion with use; dosage adjustment recommended.

Use with caution in elderly patients; dosage adjustment recommended. Monitor for impaired cognitive and/or motor performance, confusion, and potential for falling. Dosage form specific issues:

Capsules contain tartrazine; avoid in patients with sensitivity; reactions may be more frequently seen in patients with aspirin hypersensitivity; use caution in patients with asthma. Other warnings/precautions:

Symptomatic treatment of insomnia should be initiated only after careful evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7 to 10 days may indicate psychiatric and/or medical illness.

Because of the rapid onset of action, administer immediately prior to bedtime or after the patient has gone to bed and is having difficulty falling asleep.

Abrupt discontinuance or rapid dose decreases may lead to withdrawal symptoms.