Two medicines, side by side
Temazepam vs zolpidem
Temazepam and zolpidem are both labeled for insomnia. Drugs@FDA records approvals of temazepam since 1981 and of zolpidem since 1992. Pharmacies paid $0.0767 per temazepam 15 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, temazepam is a benzodiazepine and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Check it at the source: the temazepam FDA label on DailyMed (effective June 9, 2026); the zolpidem FDA label on DailyMed (effective August 15, 2022).
Highlights of the temazepam record
Temazepam (Restoril) · label of June 9, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Used for
From the label: indicationsRestoril ® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Restoril ® (temazepam) should be used for short periods of time (7 to 10 days). […]
On the market
- Earliest approval on file
- February 27, 1981
- Generic labelers
- 20 labelers
- Pharmacy cost
- $0.0767 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
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 (Temazepam label of June 9, 2026, Zolpidem label of August 15, 2022); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do temazepam and zolpidem differ on the record?
In FDA's classes, temazepam is a benzodiazepine and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Half-life, in each label's words: Temazepam, “The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the …”; Zolpidem, “Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem …”
Both labels carry a boxed warning; the records quote them.
Generics: temazepam since 1986; zolpidem since 2007 (Drugs@FDA).
| Temazepam | Zolpidem | |
|---|---|---|
| Labeled for | Insomnia | Insomnia |
| Pharmacologic class | Benzodiazepine | 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) | The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study population and … | 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) | February 27, 1981 | December 16, 1992 |
| First generic approved | July 10, 1986 | April 23, 2007 |
| Generic labelers (NDC) | 20 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0767 per capsule (Temazepam 15 mg capsule) | $0.0344 per tablet (Zolpidem tartrate 5 mg tablet) |
| 12-month price change | +0.5% | -0.3% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 37,475 | 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?
Temazepam label, drug interactionsThe benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.
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 temazepam
- every medicine labeled for the same conditions