Two medicines, side by side
Cyclobenzaprine vs diazepam
Cyclobenzaprine and diazepam are both labeled for muscle spasms and spasticity. Drugs@FDA records approvals of cyclobenzaprine since 1977 and of diazepam since 1963. Pharmacies paid $0.0171 per cyclobenzaprine 10 mg tablet and $0.0283 per diazepam 10 mg tablet (NADAC, October 7, 2026). Cyclobenzaprine's other strengths are brand-only: $29.61 per tablet (Tonmya 2.8 mg tablet sl). In FDA's classes, cyclobenzaprine is a muscle relaxant and diazepam a benzodiazepine.
Check it at the source: the cyclobenzaprine FDA label on DailyMed (effective February 21, 2025); the diazepam FDA label on DailyMed (effective August 11, 2026).
Highlights of the cyclobenzaprine record
Cyclobenzaprine (Flexeril) · label of February 21, 2025
Used for
From the label: indicationsCyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. […]
On the market
- Earliest approval on file
- August 26, 1977
- Generic labelers
- 59 labelers
- Pharmacy cost
- $0.0171 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Highlights of the diazepam record
Diazepam (Valium) · label of August 11, 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: indicationsValium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. […]
On the market
- Earliest approval on file
- November 15, 1963
- Generic labelers
- 45 labelers
- Pharmacy cost
- $0.0283 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Cyclobenzaprine label of February 21, 2025, Diazepam label of August 11, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do cyclobenzaprine and diazepam differ on the record?
In FDA's classes, cyclobenzaprine is a muscle relaxant and diazepam a benzodiazepine.
Half-life, in each label's words: Cyclobenzaprine, “Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8 to 37 hours; n=18); …”; Diazepam, “The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours.”
Only the diazepam label carries a boxed warning.
Generics: cyclobenzaprine since 1988; diazepam since 1985 (Drugs@FDA).
DEA schedule: cyclobenzaprine none; diazepam CIV.
| Cyclobenzaprine | Diazepam | |
|---|---|---|
| Labeled for | Muscle spasms and spasticity, Nerve pain and fibromyalgia | Anxiety, Muscle spasms and spasticity |
| Pharmacologic class | Muscle Relaxant | Benzodiazepine |
| How it works (label) | n/a | n/a |
| Half-life (label) | Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8 to 37 hours; n=18); plasma clearance is 0.7 L/min. | The initial distribution phase has a half-life of approximately 1 hour, although it may range up to >3 hours. |
| Earliest approval on file (Drugs@FDA) | August 26, 1977 | November 15, 1963 |
| First generic approved | February 29, 1988 | September 4, 1985 |
| Generic labelers (NDC) | 59 labelers | 45 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0171 per tablet (Cyclobenzaprine 10 mg tablet) | $0.0283 per tablet (Diazepam 10 mg tablet) |
| 12-month price change | -10% | -5% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 5 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 50,442 | 121,010 |
| DEA schedule | none | 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?
Cyclobenzaprine label, warningsIf concomitant treatment with cyclobenzaprine hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see PRECAUTIONS :
Diazepam label, drug interactionsCentrally Acting Agents If Valium is to be combined with other centrally acting agents, careful consideration should be given to the pharmacology of the agents employed particularly with compounds that may potentiate or be potentiated by the action of Valium, such as phenothiazines, antipsychotics, anxiolytics/sedatives, hypnotics, anticonvulsants, narcotic analgesics, anesthetics, sedative antihistamines …
Source: FDA drug labels via openFDA
What next?
- Alternatives to cyclobenzaprine
- every medicine labeled for the same conditions