Dosing and uses of Zaleplon (Sonata)
Adult dosage forms and strengths
capsule: Schedule IV
- 5mg
- 10mg
Insomnia (Short-term Use)
10-20 mg PO qHS, range 5-20 mg/day
Renal Impairment
Mild to moderate impairmet: No dose adjustment necessary
Severe impairment: Not studied
Hepatic Impairment
Mild to moderate impairment: 5 mg at bedtime
Severe impairment: Not recommended
Pediatric dosage forms and strengths
Not recommended
Geriatric dosage forms and strengths
5 mg PO qHS; not to exceed 10 mg/day
Zaleplon (Sonata) adverse (side) effects
>10%
Headache (38%)
1-10%
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%)
<1%
Fever
Photosensitivity
Anorexia
Colitis
Periphipheral edema
Amnesia
Anxiety
Depersonalization
Hallucination
Hypesthesia
Vertigo
Epistaxis
Abnl vision
Ear pain
Hyperacusis
Parosmia
Postmarketing Reports
Anaphylactic/anaphylactoid reactions, including severe reactions
Nightmares
Warnings
Contraindications
Hypersensitivity
Severe hepatic impairment
Cautions
May impair ability to perform hazardous tasks
Depression, hepatic impairment
Amnesia may occur
Sleep related activities may occur
Use caution in patients respiratory diseases or patients experiencing clinical depression (condition may worsen)
Effects of other CNS depressants being taken concurrently may be potentiated
Pregnancy and lactation
Pregnancy category: C
Lactation: small amount secreted in breast milk, not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Zaleplon (Sonata)
Mechanism of action
Pyrazolopyrimidine; GABA-BZD receptor complex agonist
Pharmacokinetics
Half-life elimination: 1 hr
Duration: Shorter than zolpidem
Peak Plasma Time: 1 hr
Bioavailability: 30% (undergoes extensive presystemic metabolism)
Protein Bound: 45-75%
Vd: 1.4 L/kg
Metabolism: mostly by aldehyde oxidase; some by CYP3A4
Metabolites: Inactive
Total Body Clearance: 3 L/hr/kg
Excretion: urine 70%; feces 17%
