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zaleplon (Sonata)
Tradename: Sonata. DEA-controlled substance: class 4.
Indications:
- treatment of insomnia
Dosage: 5-20 mg PO QHS.
Tabs: 5 & 10 mg.
Pharmacokinetics:
1) bioavailability is 30%
2) peak serum levels one hour after oral dose
3) peak serum concentration of 27 ng/mL after 15 mg PO
4) metabolized in the liver by cytochrome P450 3A4 to desmethylzaleplon (active) plus other inactive metabolites
5) elimination 1/2life of 1 hour (unchanged in older adults)
6) 20 mg of zaleplon is comparable to 10 mg of zolpidem
Adverse effects:
1) most common
a) headache
b) somnolence
c) dizziness
2) psychomotor impairment at doses > 15-20 mg
3) transient leukopenia (rare)
4) increase serum transaminases (rare)
5) blurred vision (> 40 mg)
6) minimal abuse potential
* Boxed warning:
- rare risks for sleepwalking, sleepdriving, & other unusual behaviors (i.e., using a stove while sleeping) [3]
Drug interactions:
1) any drug that inhibits cyt P450 3A4 may increase levels of zaleplon
2) any drug that induces cyt P450 3A4 may diminish levels of zaleplon
Mechanism of action:
1) non-benzodiazepine GABA receptor agonist
2) pyrazolopyrimidine
Interactions
drug adverse effects (more general classes)
General
sedative/hypnotic (tranquilizer)
Properties
MISC-INFO: elimination route LIVER
pregnancy-category B
safety in lactation -
Database Correlations
PUBCHEM cid=5719
References
- Drugdex(R) Drug Evaluation
- Prescriber's Letter 13(3): 2006
Cytochrome P450 drug interactions
Detail-Document#: 220233
(subscription needed) http://www.prescribersletter.com
- FDA News Release. April 30, 2019
FDA requires stronger warnings about rare but serious incidents
related to certain prescription insomnia medicines.
Updated warnings for eszopiclone, zaleplon and zolpidem.
https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warnings-about-rare-serious-incidents-related-certain-prescription-insomnia
- Marbin A et al
Zaleplon Versus Zolpidem Use in Older Adults Being Treated for Insomnia: A Review.
Am J Geriatr Psychiatr. 2023. 31(3)S68-S69
Not indexed in PubMed
https://www.sciencedirect.com/science/article/abs/pii/S1064748123000544