zaleplon

Adjunctive therapy

Brands: SONATA

Last reviewed 2025-12-28

Reviewed by PsychMed Editorial Team.

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Quick answers

What is zaleplon?
Zaleplon (brand Sonata) is a short-acting non-benzodiazepine hypnotic (“Z-drug”) approved for insomnia, primarily targeting sleep onset.
What is SONATA?
SONATA is a brand name for zaleplon.
What is SONATA (zaleplon) used for?
Label indications include: Insomnia (label).
What drug class is SONATA (zaleplon)?
Non-benzodiazepine hypnotic (“Z-drug”); GABA-A receptor positive allosteric modulator.
What strengths does SONATA (zaleplon) come in?
Capsules: 5 mg, 10 mg (some products also include 20 mg).

Snapshot

Class: Adjunctive therapy
Common US brands: SONATA
Therapeutic drug monitoring not routinely recommended.
Last reviewed: 2025-12-28

Label indications

Insomnia (label).

View labelExact

Clinical Highlights

Zaleplon (brand Sonata) is a short-acting non-benzodiazepine hypnotic (“Z-drug”) approved for insomnia, primarily targeting sleep onset. Because duration is short, zaleplon is generally a better fit for difficulty falling asleep than for frequent nighttime awakenings; if sleep maintenance is the primary problem, consider other options rather than increasing hypnotic burden.

The key safety issues are complex sleep behaviors (boxed warning), next-day impairment (especially if taken with less than a full night of sleep remaining), and additive sedation with alcohol or other CNS depressants—risks that are magnified in older adults and with polypharmacy.
Treat zaleplon as a time-limited adjunct alongside CBT-I and sleep hygiene, and reassess ongoing need at every refill decision.
The compare view, zaleplon evidence feed, and zaleplon print page can help weigh alternatives and support safety counseling.
Approved for insomnia (primarily sleep onset); treat as a time-limited adjunct to CBT-I and sleep hygiene rather than a chronic nightly default.
Generic formulations are widely available; clear guardrails (short course, refill checkpoints, stop plan) help prevent long-term continuation without reassessment.

Dosing & Formulations

Capsules: 5 mg, 10 mg (some products also include 20 mg). Recommended dose is 10 mg immediately before bedtime or after going to bed and having difficulty falling asleep; elderly/debilitated patients generally use 5 mg (label).

Do not take unless able to get a full night’s sleep (7–8 hours) before needing to be active again; avoid taking with or immediately after a heavy, high-fat meal (label).
Avoid redosing if sleep does not occur quickly; instead reassess the insomnia diagnosis and drivers (sleep apnea, substances, mood episodes) before escalating or adding sedatives.

Monitoring & Risks

Boxed warning: Complex sleep behaviors (sleepwalking, sleep driving) can cause serious injuries—discontinue if they occur (label). Next-day impairment: risk rises with higher doses, polypharmacy, or if taken with less than a full night of sleep remaining; assess driving and work safety (label).

Misuse and dependence risk (Schedule IV): screen for substance use disorders and avoid open-ended refills.
Tolerance and rebound insomnia can occur with chronic use; plan periodic taper attempts rather than indefinite continuation.
In patients with depression or suicidality risk, monitor mood closely; worsening depression has been reported with sedative-hypnotics (label).

Drug Interactions

Avoid alcohol and other CNS depressants when possible. Inhibitors/inducers of aldehyde oxidase and CYP3A4 can alter exposure; reassess efficacy and tolerability with major interaction changes (label).

Avoid combining with other sedative-hypnotics, opioids, or benzodiazepines when possible due to additive impairment and safety risks.

Practice Notes

Favor CBT-I and sleep hygiene first; use zaleplon for short, clearly bounded courses with stop plans. If insomnia is chronic, treat underlying drivers (depression, PTSD, substances, pain, sleep apnea) rather than escalating hypnotic doses.

Because of its short duration, zaleplon is best reserved for sleep-onset insomnia; if repeated awakenings predominate, consider other options rather than increasing hypnotic burden.

References

Zaleplon prescribing information — DailyMed (2025)
Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline — Journal of Clinical Sleep Medicine (2017)
Efficacy and Acceptability of Pharmacological Interventions for Insomnia in Patients With Severe Mental Illness — Acta Psychiatrica Scandinavica (2025)
Residual effects of medications for sleep disorders on driving performance — European Neuropsychopharmacology (2024)