Zaleplon

DEA Class;  Rx

Common Brand Names; Sonata

Hypersensitivity

Patients who have experienced complex sleep behaviors after taking zaleplon

• Headache (38%)
• Dizziness (7-9%)
• Nausea (6-8%)
• Abdominal pain (6%)
• Weakness (5-7%)
• Dysmenorrhea (3-4%)
• Eye pain (3-4%)
• Amnesia (2-4%)
• Parasthesia (3%)
• Tremor (2%)
• Fever
• Photosensitivity
• Anorexia
• Colitis
• Periphipheral edema
• Amnesia
• Anxiety
• Depersonalization
• Hallucination
• Hypesthesia
• Vertigo
• Epistaxis
• Abnl vision
• Ear pain
• Hyperacusis
• Parosmia

Use caution in mild-to-moderate hepatic impairment; not recommended with severe hepatic impairment

Amnesia may occur

Use caution in patients respiratory diseases or patients experiencing clinical depression (condition may worsen)

Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls

In primarily depressed patients treated with sedative-hypnotics, worsening of depression, including suicidal thoughts and actions (including completed suicides), reported

Post-marketing reports have shown complex sleep behaviors may occur with drug alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants

Dosage adjustments of drug and of other concomitant CNS depressants may be necessary when drug administered with such agents because of potentially additive effects

Use with other sedative-hypnotics at bedtime or the middle of the night not recommended

Risk of next-day psychomotor impairment, including impaired driving, is increased if drug taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than recommended dose taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase blood levels of zaleplon; warn patients against driving and other activities requiring complete mental alertness if drug taken in these circumstances

Signs and symptoms associated with withdrawal from other CNS depressant drugs reported following rapid dose decrease or abrupt discontinuation of use of sedative/hypnotics

Pregnancy Category: C

Lactation: small amount secreted in breast milk, not recommended