Zaleplon

Pronunciation: ZAL-eh-plon.

Generic name
zaleplon
Drug class
Non-benzodiazepine sedative-hypnotic ('Z-drug', pyrazolopyrimidine class)
Form
Capsule (5 mg and 10 mg)
Route
Oral
Legal status
Prescription-only, Schedule IV controlled substance in the United States, where it remains currently authorised and marketed (as a generic). Previously authorised but now withdrawn/cancelled in the European Union, Canada, and Australia. United Kingdom status is inferred from the shared pre-Brexit EU authorisation, not independently confirmed. New Zealand status could not be confirmed this session.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Sonata (6) · Full directory

What zaleplon is and how it works

Zaleplon is a non-benzodiazepine sedative-hypnotic ('Z-drug') used for the short-term treatment of insomnia, specifically difficulty falling asleep. It has a very short half-life, and studies have shown it decreases the time it takes to fall asleep for up to 30 days, but has not been shown to increase total sleep time or reduce nighttime awakenings. (1) (2)

Zaleplon carries the same current, mandatory FDA Boxed Warning added in 2019 to all three widely-used Z-drugs (zaleplon, zolpidem, eszopiclone): complex sleep behaviors such as sleepwalking, sleep-driving, or other activities while not fully awake, which have caused serious injuries and deaths. Zaleplon's commercial availability has also receded substantially worldwide: of the six markets checked, it remains authorised and actively marketed (as a generic) only in the United States; it has been withdrawn or had its registration cancelled in the European Union, Canada, and Australia.

Mechanism of action: how zaleplon works

Zaleplon is a pyrazolopyrimidine non-benzodiazepine hypnotic that binds selectively to the benzodiazepine-1 (omega-1) receptor subtype within the GABA-A receptor complex, with a very short elimination half-life (approximately 1 hour). (1)

What zaleplon is used for

Short-term treatment of insomnia

Used for the short-term treatment of insomnia in adults, specifically for difficulty falling asleep. Has been shown to decrease the time to sleep onset for up to 30 days in controlled studies, but has not been shown to increase total sleep time or decrease nighttime awakenings. (1)

Before taking zaleplon

Do not take / not appropriate for

  • Do not take if you have previously had an episode of complex sleep behavior (sleepwalking, sleep-driving, or similar) after taking zaleplon, zolpidem, or eszopiclone. (all countries) (1) (2)
  • Do not take if you are allergic to zaleplon or any ingredient in the capsule. (all countries) (1)
  • Do not take unless you can devote a full night (7-8 hours) to sleep before you need to be active again. (all countries) (1)

Tell your clinician about

  • Any prior episode of sleepwalking, sleep-driving, or similar activity while not fully awake, on any sedative-hypnotic medicine.
  • If you have depression or a history of suicidal thoughts.
  • If you have breathing problems, such as sleep apnoea or other respiratory conditions.
  • If you have a history of alcohol or substance misuse.
  • If you have an aspirin/sulfite sensitivity, since this product contains FD&C Yellow No. 5 (tartrazine).
  • If you are pregnant, planning pregnancy, or breastfeeding.
  • All other medicines you take, especially other sedatives, opioids, or anything that causes drowsiness.
(1)

How to take zaleplon

  • Take immediately before bedtime, only when you are able to get a full night's sleep (7-8 hours) before you need to be active again.
  • Do not take with or immediately after a high-fat/heavy meal, as this can delay onset of action.
  • Do not take more than prescribed, and do not take it earlier in the evening than directed.
  • Never combine with alcohol or other sedating medicines.
  • Do not drive or operate machinery after taking zaleplon and until you are fully awake the next day.
  • Whether to stop or change the dose is a decision for your prescriber -- abrupt discontinuation can cause withdrawal symptoms.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Zaleplon is taken only at bedtime, as needed, not on a fixed daily schedule -- there is no 'missed dose' to make up. Only take it when you are about to go to sleep and can devote a full night to sleep.

Overdose

Seek urgent medical attention if an overdose is suspected. Symptoms can include marked drowsiness, confusion, impaired coordination, slowed or difficult breathing, and, in severe cases, coma. Do not wait for symptoms to worsen before seeking help. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Drowsiness.

What to notice: Drowsiness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Dizziness, lightheadedness.

What to notice: Dizziness, lightheadedness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Difficulty with coordination.

What to notice: Difficulty with coordination.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Paresthesia (pins-and-needles sensation).

What to notice: Paresthesia (pins-and-needles sensation).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Complex sleep behaviors (current, mandatory FDA Boxed Warning) — high caution

Symptoms: Sleepwalking, sleep-driving, preparing and eating food, making phone calls, or other activities while not fully awake, with no memory of the event afterward.

Action: If this happens, contact your prescriber immediately -- continuing zaleplon after such an episode is contraindicated. This can occur even at the lowest recommended dose, after just one dose, and in people with no prior history of it. Serious injuries and deaths have occurred. (1) (2)

Next-day impairment — high caution

Symptoms: Impaired alertness, coordination, or driving ability the next day, especially if you did not get a full night's sleep, took more than the recommended dose, or combined it with other sedating substances.

Action: Do not drive or perform activities requiring full alertness until you know how zaleplon affects you the next day; never take it unless you can devote a full 7-8 hours to sleep. (1)

Worsening depression or suicidal thoughts — high caution

Symptoms: New or worsening depression, thoughts of self-harm, or suicidal thoughts/actions.

Action: Seek urgent medical help if these occur -- reported primarily in people with depression treated with sedative-hypnotics. (1)

Abnormal thinking or behavioural changes — moderate caution

Symptoms: Decreased inhibition, unusual or bizarre behaviour, agitation, hallucinations, or feeling detached from yourself.

Action: Tell your prescriber promptly if these occur. (1)

Withdrawal symptoms — moderate caution

Symptoms: Symptoms similar to other sedative withdrawal (e.g. anxiety, agitation) after rapid dose reduction or abrupt stopping.

Action: Never stop taking zaleplon abruptly on your own -- talk to your prescriber about how to stop safely. (1)

Respiratory depression — moderate caution

Symptoms: Slowed or shallow breathing, particularly in people with compromised respiratory function.

Action: Tell your prescriber if you have any breathing problems, such as sleep apnoea, before starting. (1)

Tartrazine (FD&C Yellow No. 5) allergy — moderate caution

Symptoms: Allergic-type reactions, particularly in people with aspirin sensitivity.

Action: Tell your prescriber if you have a known sensitivity to tartrazine or aspirin before starting. (1)

Interactions

  • Alcohol and other CNS depressants (opioids, other sedatives) increase sedation and next-day impairment risk -- avoid combining. (1)
  • This dossier's sources did not detail an exhaustive list of drug-drug interactions beyond CNS depressants/alcohol. Tell your prescriber about all other medicines you take.

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Not recommended during pregnancy -- no adequate studies in pregnant women per the US label reviewed. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Nursing mothers are advised not to take zaleplon, since it is excreted in breast milk and its effects on nursing infants are unknown. (1) (2) (3) (4) (5) (6) (7)

Children

This dossier's sources did not detail paediatric-specific dosing or safety information; not indicated for use in children per the sources reviewed. (1) (2) (3) (4) (5) (6) (7)

Elderly

Lower doses are generally recommended in the elderly per the sources reviewed, given increased sensitivity to sedative-hypnotic effects. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Lower doses are generally recommended in people with hepatic impairment per the sources reviewed. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

This dossier's sources did not detail specific renal dosing guidance. (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Screen for prior complex sleep behavior episodes on any Z-drug.
  • Screen for depression, respiratory conditions, and substance-use history.
  • Confirm the person can devote a full night's sleep before taking a dose.

During treatment

  • Watch for any signs of complex sleep behaviors, ideally with input from a partner or household member.
  • Watch for next-day impairment before driving or operating machinery.
  • Watch for worsening depression or new suicidal thoughts.
  • Reassess regularly, since zaleplon is intended for short-term use only.
(1)

Storage

Store at room temperature, away from moisture and heat, out of reach of children. As a controlled substance, keep secure from unauthorised access.

Study the drug class: Z-drugs and other hypnotics

Professional information

Clinician-facing context only, sourced from the current US DailyMed generic zaleplon capsule label, the FDA's 2019 class-wide boxed-warning communication, EMA, Health Canada, and TGA Australia sources reviewed for this dossier; verify against the current full label for the specific product before prescribing.

United States

Indication: Short-term insomnia treatment

Dose summary: Individualised, commonly 5-10 mg immediately before bedtime; lower doses (e.g. 5 mg) generally recommended in the elderly and in hepatic impairment.

Renal context: Sources reviewed for this dossier did not detail specific renal dosing guidance. (1)

Mechanism of action

Hepatic guidance

Lower doses are generally recommended in hepatic impairment per the sources reviewed for this dossier.

Overdose note

Manage supportively (airway protection, monitoring); flumazenil has been used as a benzodiazepine-receptor-site antagonist in some sedative-hypnotic overdoses, though specific zaleplon overdose antidote data were not detailed in the sources reviewed for this dossier -- follow current poison-control/emergency guidance. (1)

Frequently asked questions

Is zaleplon available in the US, UK, EU, Canada, Australia, and New Zealand?

Zaleplon's availability has receded substantially worldwide. Of the six markets checked this session, it remains authorised and marketed (as a generic; the original Sonata brand is discontinued) only in the United States. It was withdrawn from the European Union in 2015 (commercial reasons, not a safety recall), from Canada in 2007, and from Australia in 2019/2022. The United Kingdom shared the same pre-Brexit EU authorisation withdrawn in 2015, with no separate UK-specific action independently confirmed this session. New Zealand's status could not be confirmed via a direct official search this session. (1) (3) (5) (6) (4) (7)

What is the most important safety warning for zaleplon?

The FDA added a mandatory Boxed Warning to zaleplon (and to zolpidem and eszopiclone) on 30 April 2019 for complex sleep behaviors -- sleepwalking, sleep-driving, and other activities while not fully awake, some of which have resulted in serious injuries or death. This is current and applies to zaleplon specifically, not an old or optional warning. Zaleplon is contraindicated in anyone who has previously had such an episode on any of these three medicines. (1) (2)

Can I buy zaleplon/Sonata online in the UK?

Be cautious. Zaleplon's UK/EU-wide marketing authorisation was withdrawn in 2015, and no separate current UK licensing action was independently confirmed this session. Online pharmacy websites advertising zaleplon/Sonata for sale in the UK were found during this research, but they are not relied upon here as evidence of legitimate current availability -- purchasing a lapsed, controlled-substance-adjacent medicine from an unverified online source carries real grey-market and counterfeit-product risk. Speak to a UK-licensed prescriber about currently approved alternatives instead. (4)

What is the mechanism of action of zaleplon?

Zaleplon is a pyrazolopyrimidine non-benzodiazepine hypnotic that binds selectively to the benzodiazepine-1 (omega-1) receptor subtype within the GABA-A receptor complex, with a very short elimination half-life (approximately 1 hour). (1)

What is the generic name of Zaleplon?

The generic name is zaleplon. (1)

What class of drug is zaleplon?

Zaleplon is classed as: Non-benzodiazepine sedative-hypnotic ('Z-drug', pyrazolopyrimidine class). (1)

References

  1. ZALEPLON capsule -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved prescribing information (generic zaleplon capsule label) · United States · accessed 2026-07-30 · source 1
  2. FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines (30 April 2019)U.S. Food and Drug Administration -- Drug Safety Communication · United States · accessed 2026-07-30 · source 2
  3. Sonata (zaleplon) -- EPAR overview and 2015 EU marketing-authorisation withdrawalEuropean Medicines Agency (EMA) -- EPAR overview and public withdrawal statement · European Union · accessed 2026-07-30 · source 3
  4. UK status not independently confirmed beyond the shared EU-era authorisation and its 2015 withdrawalInferred from the EU-wide 2015 withdrawal (United Kingdom was an EU member state at the time); no separate/distinct MHRA action found · United Kingdom · accessed 2026-07-30 · source 4
  5. STARNOC (zaleplon) -- Cancelled Post Market, DINs 02242219 / 02242220Health Canada -- Drug Product Database (DPD) · Canada · accessed 2026-07-30 · source 5
  6. SONATA zaleplon 5mg and 10mg capsule blister pack -- Cancelled under Section 30(1)(c) of the ActTherapeutic Goods Administration (TGA), Australia -- ARTG cancellation notices · Australia · accessed 2026-07-30 · source 6
  7. New Zealand availability could not be directly confirmed via an official Medsafe source this sessionn/a -- no direct official Medsafe register search performed successfully this session; only secondary/AI-search-synthesised claims found · New Zealand · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient zaleplon names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Zaleplon (generic, multiple manufacturers) (1)FDA approved currently marketed confirmed · 5 mg, 10 mg · multiple generic manufacturers (e.g. Pfizer, Aurobindo, Teva)
  • Sonata (original brand) (1)brand discontinued confirmed · 5 mg, 10 mg · n/a -- discontinued

United Kingdom

  • Sonata (4)shared eu era authorisation withdrawn 2015 uk specific action not independently confirmed · 5 mg, 10 mg · Meda AB (EU-wide era)

Canada

  • Starnoc (5)Health Canada cancelled post market 2007-09-27 confirmed · 5 mg, 10 mg · Servier Canada Inc.

Australia

  • Sonata (6)TGA ARTG cancelled confirmed · 5 mg, 10 mg · Pfizer Australia Pty Ltd
View brands in additional countries.

European Union

Sonata (3)

This page provides general reference information about zaleplon and is not a substitute for advice from your pharmacist or clinician. Zaleplon carries a current, mandatory FDA warning about complex sleep behaviors -- if you experience sleepwalking, sleep-driving, or similar activity while not fully awake, contact your prescriber immediately.

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