Prescription medicine
Zaleplon First approved as Sonata
Zaleplon (Sonata) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.141 per zaleplon 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the zaleplon FDA label on DailyMed (effective May 8, 2024, Aurobindo Pharma Limited); the NDA 20859 record on Drugs@FDA; every zaleplon label on DailyMed.
Highlights of the record
FDA label of May 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
COMPLEX SLEEP BEHAVIORS.
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior (see CONTRAINDICATIONS and Complex Sleep Behaviors under WARNINGS ). Zaleplon is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zaleplon in a safe place to prevent misuse and abuse. Selling or giving away zaleplon may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Used for
From the label: indications and usageZaleplon capsules are indicated for the short-term treatment of insomnia.
Forms and strengths
- 5 mg
- 10 mg
Capsule.
On the market
- Earliest approval on file
- August 13, 1999 Sonata, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first June 6, 2008; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.141 per capsule Zaleplon 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,589 through July 30, 2026
What is zaleplon used for?
From the label: indications and usageZaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). They have not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
Conditions named in the indications of zaleplon's FDA labels, with every medicine labeled for each:
From other zaleplon labelsInsomnia: INDICATIONS AND USAGE Zaleplon capsules are indicated for the short-term treatment of insomnia.
FDA pharmacologic class: gamma-Aminobutyric Acid A Receptor Agonist.
Source: FDA drug label (ZALEPLON), Aurobindo Pharma Limited, effective May 8, 2024 (SPL set e092f3ca-bf44-4568-a72c-3fb2cf5b192b), via openFDA; the full label on DailyMed
What does the patient leaflet for zaleplon say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about zaleplon?Zaleplon may cause serious side effects including complex sleep behaviors that may cause serious injury and death. After taking zaleplon, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with zaleplon whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include: driving a car ("sleep-driving") making and eating food talking on the phone having sex sleep-walking Important: 1. Take zaleplon exactly as prescribed Do not take more zaleplon than prescribed. Take zaleplon right before you get in bed, not sooner. 2. Do not take zaleplon if you: have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking zaleplon drink alcohol take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zaleplon with your other medicines cannot get a full night’s sleep 3. Stop taking zaleplon and call your doctor right away if you find out that you have done any of the above activities after taking zaleplon.
From the patient leaflet: How should I store zaleplon?Store zaleplon at room temperature between 68° and 77°F (20º to 25ºC). Protect from light. Keep zaleplon and all medicines out of the reach of children. General Information about zaleplon Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use zaleplon for a condition for which it was not prescribed. Do not give zaleplon to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about zaleplon. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zaleplon that was written for healthcare professionals. If you would like more information, contact the Aurobindo Pharma USA, Inc. at 1-866-850-2876.
Source: FDA drug label (ZALEPLON), Aurobindo Pharma Limited, effective May 8, 2024 (SPL set e092f3ca-bf44-4568-a72c-3fb2cf5b192b), via openFDA; the full label on DailyMed
Is there a generic for zaleplon (Sonata)?
The FDA approved the first generic zaleplon on June 6, 2008. 10 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists zaleplon from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2008 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for zaleplon (Sonata)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.141 per Zaleplon 10 mg capsule, down 10% from $0.157 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zaleplon 10 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Zaleplon 10 mg capsule | Generic | $0.141 per capsule | $4.23 | -10% |
| Zaleplon 5 mg capsule | Generic | $0.157 per capsule | $4.70 | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the zaleplon label say about other medicines?
The zaleplon label names 16 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital. |
| Cimetidine | drug interactions | Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4 Cimetidine: Cimetidine inhibits both aldehyde oxidase ( in vitro ) and CYP3A4 ( in vitro and in vivo ), the primary and secondary enzymes, respectively, responsible for zaleplon metabolism. |
| Digoxin | drug interactions | Drugs with a Narrow Therapeutic Index Digoxin: Zaleplon (10 mg) did not affect the pharmacokinetic or pharmacodynamic profile of digoxin (0.375 mg q24h for 8 days). |
| Diphenhydramine | drug interactions | Diphenhydramine: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known. |
| Erythromycin | drug interactions | Coadministration of single, oral doses of zaleplon with erythromycin (10 mg and 800 mg respectively), a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon’s maximal plasma concentrations and a 20% increase in the area under the plasma concentration-time curve. |
| Ibuprofen | drug interactions | Drugs That Alter Renal Excretion Ibuprofen: Ibuprofen is known to affect renal function and, consequently, alter the renal excretion of other drugs. |
| Imipramine | drug interactions | Imipramine Coadministration of single doses of zaleplon 20 mg and imipramine 75 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. |
| Ketoconazole | drug interactions | Other strong selective CYP3A4 inhibitors such as ketoconazole can also be expected to increase the exposure of zaleplon. |
| Paroxetine | drug interactions | Paroxetine Coadministration of a single dose of zaleplon 20 mg and paroxetine 20 mg daily for 7 days did not produce any interaction on psychomotor performance. |
| Phenobarbital | drug interactions | An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital. |
| Phenytoin | drug interactions | An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital. |
| Promethazine | drug interactions | Promethazine Coadministration of a single dose of zaleplon and promethazine (10 and 25 mg, respectively) resulted in a 15% decrease in maximal plasma concentrations of zaleplon, but no change in the area under the plasma concentration-time curve. |
| Rifampin | drug interactions | Drugs That Induce CYP3A4 Rifampin CYP3A4 is ordinarily a minor metabolizing enzyme of zaleplon. |
| Thioridazine | drug interactions | Thioridazine Coadministration of single doses of zaleplon 20 mg and thioridazine 50 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. |
Every other medicine the zaleplon label names
| Medicine named | Section | What the label says |
|---|---|---|
| Venlafaxine | drug interactions | Venlafaxine Coadministration of a single dose of zaleplon 10 mg and multiple doses of venlafaxine ER (extended release) 150 mg did not result in any significant changes in the pharmacokinetics of … |
| Warfarin | drug interactions | Multiple oral doses of zaleplon (20 mg q24h for 13 days) did not affect the pharmacokinetics of warfarin (R+)- or (S-)-enantiomers or the pharmacodynamics (prothrombin time) following a single 25 mg … |
Source: FDA drug label (ZALEPLON), Aurobindo Pharma Limited, effective May 8, 2024 (SPL set e092f3ca-bf44-4568-a72c-3fb2cf5b192b), via openFDA; the full label on DailyMed
What do FAERS reports show for zaleplon?
The FDA Adverse Event Reporting System holds 1,589 reports that list zaleplon among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 176 are coded as a death and 347 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as zaleplon?
11 other medicines are given the same way (oral) and in the same FDA class as zaleplon or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Zolpidem | Insomnia | 39 labelers | $0.0344 per tablet 5 mg tablet | No current entry |
| Eszopiclone | Insomnia | 26 labelers | $0.0993 per tablet 1 mg tablet | No current entry |
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Ramelteon | Insomnia | 27 labelers | $0.660 per tablet 8 mg tablet | A presentation being discontinued |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
| Estazolam | Insomnia | 3 labelers | $0.839 per tablet 2 mg tablet | No current entry |
| Suvorexant | Insomnia | none listed | $15.21 per tablet 10 mg tablet | No current entry |
| Daridorexant | Insomnia | none listed | $16.70 per tablet 25 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does zaleplon compare with medicines for the same use?
3 side-by-side pages set zaleplon beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to zaleplon
- 11 medicines for the same use
- Zaleplon side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other