Prescription medicine
Amitriptyline and chlordiazepoxide First approved as Limbitrol
Amitriptyline and chlordiazepoxide (Limbitrol) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $1.20 per unit (Chlordiazepo-amitriptyl 5-12.5) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the amitriptyline and chlordiazepoxide FDA label on DailyMed (effective March 15, 2026, Mylan Pharmaceuticals Inc.); the NDA 16949 record on Drugs@FDA; every amitriptyline and chlordiazepoxide label on DailyMed.
Highlights of the record
FDA label of March 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; DEPENDENCE AND WITHDRAWAL REACTIONS.
and SUICIDAL THOUGHTS AND BEHAVIORS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ).
The use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing chlordiazepoxide and amitriptyline hydrochloride tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ).
The continued use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. […]
Used for
From the label: indications and usageChlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.
Forms and strengths
- 5 mg / 14 mg
- 10 mg / 27.98 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 23, 1977 Limbitrol, Chartwell Rx; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first December 10, 1986; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.20 per unit Chlordiazepo-amitriptyl 5-12.5
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4 through July 30, 2026
What is amitriptyline and chlordiazepoxide used for?
From the label: indications and usageChlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
Conditions named in the indications of amitriptyline and chlordiazepoxide's FDA labels, with every medicine labeled for each:
From other amitriptyline and chlordiazepoxide labelsAnxiety: INDICATIONS AND USAGE Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.
FDA pharmacologic class: Benzodiazepine and Tricyclic Antidepressant.
Source: FDA drug label (Chlordiazepoxide and Amitriptyline Hydrochloride), Mylan Pharmaceuticals Inc., effective March 15, 2026 (SPL set 66a756f2-ac77-451c-a19a-08896d73b15c), via openFDA; the full label on DailyMed
What does the patient leaflet for amitriptyline and chlordiazepoxide 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 chlordiazepoxide and amitriptyline hydrochloride tablets?Chlordiazepoxide is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: o shallow or slowed breathing o breathing stops (which may lead to the heart stopping) o excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking chlordiazepoxide and amitriptyline hydrochloride tablets with opioids affect you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, which can lead to overdose and serious side effects including coma and death. o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. o You can develop an addiction even if you take chlordiazepoxide and amitriptyline hydrochloride tablets exactly as prescribed by your healthcare provider. o Take chlordiazepoxide and amitriptyline hydrochloride tablets exactly as your healthcare provider prescribed. o Do not share your chlordiazepoxide and amitriptyline hydrochloride tablets with other people. o Keep chlordiazepoxide and amitriptyline hydrochloride tablets in a safe place and away from children. […]
From the patient leaflet: How should I store chlordiazepoxide and amitriptyline hydrochloride tablets?Store chlordiazepoxide and amitriptyline hydrochloride tablets at room temperature between 20° to 25°C (68° to 77°F). • Store in a dry place. • Keep chlordiazepoxide and amitriptyline hydrochloride tablets in a tightly closed, child-resistant container and out of the light. Keep chlordiazepoxide and amitriptyline hydrochloride tablets and all medicines out of the reach of children.
Source: FDA drug label (Chlordiazepoxide and Amitriptyline Hydrochloride), Mylan Pharmaceuticals Inc., effective March 15, 2026 (SPL set 66a756f2-ac77-451c-a19a-08896d73b15c), via openFDA; the full label on DailyMed
Is there a generic for amitriptyline and chlordiazepoxide (Limbitrol)?
The FDA approved the first generic amitriptyline and chlordiazepoxide on December 10, 1986. 9 generic applications are approved; 2 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 amitriptyline and chlordiazepoxide from 1 labeler 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.
- 1977 earliest approval on file
- 1986 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amitriptyline and chlordiazepoxide (Limbitrol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.20 per unit (Chlordiazepo-amitriptyl 5-12.5), up 2% from $1.18 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.
- Chlordiazepo-amitriptyl 5-12.5 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chlordiazepo-amitriptyl 5-12.5 | Generic | $1.20 per unit | n/a | +2% |
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 amitriptyline and chlordiazepoxide label say about other medicines?
The amitriptyline and chlordiazepoxide label names 7 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 |
|---|---|---|
| Buspirone | warnings | … drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous … |
| Fentanyl | warnings | … with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also … |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: |
| Linezolid | warnings | … serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Lithium | warnings | … concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others … |
| Methylene blue | warnings | … MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Tramadol | warnings | … of other serotonergic drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid … |
Check amitriptyline and chlordiazepoxide against other medicines
Source: FDA drug label (Chlordiazepoxide and Amitriptyline Hydrochloride), Mylan Pharmaceuticals Inc., effective March 15, 2026 (SPL set 66a756f2-ac77-451c-a19a-08896d73b15c), via openFDA; the full label on DailyMed
What do FAERS reports show for amitriptyline and chlordiazepoxide?
The FDA Adverse Event Reporting System holds 4 reports that list amitriptyline and chlordiazepoxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 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.
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 amitriptyline and chlordiazepoxide?
11 other medicines are given the same way (oral) and in the same FDA class as amitriptyline and chlordiazepoxide or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 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 |
|---|---|---|---|---|
| Doxepin | Anxiety | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
| Clonazepam | Anxiety | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Amoxapine | Anxiety | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as amitriptyline and chlordiazepoxide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amitriptyline and chlordiazepoxide
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Amitriptyline and chlordiazepoxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other