Two medicines, side by side
Zaleplon vs zolpidem
Zaleplon and zolpidem are both labeled for insomnia. Drugs@FDA records approvals of zaleplon since 1999 and of zolpidem since 1992. Pharmacies paid $0.141 per zaleplon 10 mg capsule and $0.0344 per zolpidem tartrate 5 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, zaleplon is a gamma-aminobutyric acid a receptor agonist and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Check it at the source: the zaleplon FDA label on DailyMed (effective May 8, 2024); the zolpidem FDA label on DailyMed (effective August 15, 2022).
Highlights of the zaleplon record
Zaleplon (Sonata) · label of May 8, 2024
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.
Used for
From the label: indicationsZaleplon 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. […]
On the market
- Earliest approval on file
- August 13, 1999
- Generic labelers
- 9 labelers
- Pharmacy cost
- $0.141 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the zolpidem record
Zolpidem (Ambien) · label of August 15, 2022
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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsEdluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. […]
On the market
- Earliest approval on file
- December 16, 1992
- Generic labelers
- 39 labelers
- Pharmacy cost
- $0.0344 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 6
Source: FDA drug labels via openFDA (Zaleplon label of May 8, 2024, Zolpidem label of August 15, 2022); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do zaleplon and zolpidem differ on the record?
In FDA's classes, zaleplon is a gamma-aminobutyric acid a receptor agonist and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Both labels carry a boxed warning; the records quote them.
Generics: zaleplon since 2008; zolpidem since 2007 (Drugs@FDA).
| Zaleplon | Zolpidem | |
|---|---|---|
| Labeled for | Insomnia | Insomnia |
| Pharmacologic class | gamma-Aminobutyric Acid A Receptor Agonist | gamma-Aminobutyric Acid A Receptor Positive Modulator, gamma-Aminobutyric Acid-ergic Agonist |
| How it works (label) | n/a | Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing GABA A receptors, increasing the … |
| Half-life (label) | n/a | Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem elimination half-life was 2.85 hours (range: 1.57-6.73 hr) and 2.65 hours (range: 1.75 to 3.77 hr) … |
| Earliest approval on file (Drugs@FDA) | August 13, 1999 | December 16, 1992 |
| First generic approved | June 6, 2008 | April 23, 2007 |
| Generic labelers (NDC) | 9 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.141 per capsule (Zaleplon 10 mg capsule) | $0.0344 per tablet (Zolpidem tartrate 5 mg tablet) |
| 12-month price change | -10% | -0.3% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 1,589 | 134,363 |
| DEA schedule | CIV | CIV |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Zaleplon label, warningsCoadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression.
Zolpidem label, drug interactionsCNS-active Drugs CNS Depressants Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1 , 5.2) ].
Source: FDA drug labels via openFDA
What next?
- Alternatives to zaleplon
- every medicine labeled for the same conditions