Temazepam 30 mg Capsule, 500-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Benzodiazepine class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Temazepam is used to treat insomnia (difficulty falling asleep or staying asleep). Temazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow sleep.
Read the full MedlinePlus article ↗- Temazepam is approved for short-term use only — generally 7 to 10 days. It's not meant to be a long-term sleep solution. If you're still having trouble sleeping after that time, th...
- Please don't. Alcohol and temazepam are both sedatives, and combining them makes the effects of both much stronger — not just extra sleepiness, but real risks like dangerously slow...
- Can I take temazepam with a glass of wine or a beer?
- Stopping temazepam abruptly after taking it regularly — even for a short time — can trigger withdrawal reactions. These can range from rebound insomnia and anxiety to, in more seve...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Temazepam — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.092 | $45.95 / 500 capsules |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1632 | $81.60 / 500 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Temazepam 30 mg 00228-2077-10 | Actavis | 100 capsules | $0.091 | AB | Availability likely | save 1% |
| Temazepam 30 mg 00406-9962-01 | SpecGx | 100 capsules | $0.091 | AB | Availability likely | save 1% |
| Temazepam 30 mg 43547-0614-10 | Solco | 100 capsules | $0.091 | AB | Availability likely | save 1% |
| temazepam 30 mg 50268-0780-13 | AvPAK | 30 capsules | $0.091 | AB | Availability likely | save 1% |
| Temazepam 30 mg 53746-0557-01 | Amneal | 100 capsules | $0.091 | AB | Availability likely | save 1% |
| temazepam 30 mg 67877-0147-01 | Ascend | 100 capsules | $0.091 | AB | Availability likely | save 1% |
| Temazepam 30 mgthis 65162-0557-50 | Amneal | 500 capsules | $0.092 | AB | FDA listed | — |
| Restoril 30 mg 00406-9917-01 | SpecGx | 100 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 43353-0260-15 | Aphena | 15 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 46708-0382-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 50090-0285-01 | A-S | 30 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 51407-0508-05 | Golden | 500 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 55289-0660-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 62332-0382-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 63187-0497-00 | Proficient | 100 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 63629-1057-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 63629-1621-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| temazepam 30 mg 63629-8605-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 63629-8606-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 66267-0321-30 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 68071-4083-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 68788-8081-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 71205-0915-00 | Proficient | 100 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 71335-1901-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 71335-2302-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 71335-2910-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 71335-2965-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 71610-0626-15 | Aphena | 15 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 71610-0986-28 | Aphena | 28 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 72162-1825-05 | Bryant | 500 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 72789-0449-30 | PD-Rx | 30 capsules | — | AB | FDA listed | — |
| temazepam 30 mg 76420-0475-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Temazepam 30 mg 80425-0295-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 65162-0557-03 | 30 CAPSULE in 1 BOTTLE (65162-557-03) | — | — | 2016-05-23 | Active |
| 65162-0557-10 | 100 CAPSULE in 1 BOTTLE (65162-557-10) | $0.0919 / ea | $9.19 | 2016-05-23 | Active |
| 65162-0557-11 | 1000 CAPSULE in 1 BOTTLE (65162-557-11) | — | — | 2016-05-23 | Active |
| 65162-0557-50 You're viewing this | 500 CAPSULE in 1 BOTTLE (65162-557-50) | $0.0919 / ea | $45.96 | 2016-05-23 | Active |
You're viewing one of 4 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0919 NADAC).
Pack size FAQ
What quantity is in NDC 65162-0557-50?
What is the difference between NDC 65162-0557-50 and NDC 65162-0557-03?
What NDC number is used to bill for this package of Temazepam 30 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: 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.
Follow patients for signs and symptoms of respiratory depression and sedation ( see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including temazepam, 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 temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( see WARNINGS ). The continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.
Abrupt discontinuation or rapid dosage reduction of temazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage ( see DOSAGE AND ADMINISTRATION and WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Temazepam capsules are 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 temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.
Discontinuation or Dosage Reduction of Temazepam To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly ( see WARNINGS , Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE : Dependence ).
⚠️ Warnings ▾
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe temazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of temazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking temazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when temazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see PRECAUTIONS , Drug Interactions ). Abuse, Misuse, and Addiction The use of benzodiazepines, including temazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death ( see DRUG ABUSE AND DEPENDENCE , Abuse ). Before prescribing temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
Use of temazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of temazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) ( see DOSAGE AND ADMINISTRATION , Discontinuation or Dosage Reduction of Temazepam ). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence.
Abrupt discontinuation or rapid dosage reduction of temazepam 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 , Dependence ) . Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months ( see DRUG ABUSE AND DEPENDENCE , Dependence ). Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder.
Consequently, a decision to…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1
5.6Headache 8.5
9.1Fatigue 4.8
4.7Nervousness 4.6
8.2Lethargy 4.5
3.4Dizziness 4.5
3.3Nausea 3.1
3.8Hangover 2.5
1.1Anxiety 2.0
1.5Depression 1.7
1.8Dry Mouth 1.7
2.2Diarrhea 1.7
1.1Abdominal Discomfort 1.5
1.9Euphoria 1.5
0.4Weakness 1.4
0.9Confusion 1.3
0.5Blurred Vision 1.3
1.3Nightmares 1.2
1.7Vertigo 1.2
0.8The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System – anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular – dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses – hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur.
In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal ( see WARNINGS, Abuse, Misuse, and Addiction ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.
In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency.
The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.
See the flumazenil injection Prescribing Information. Consider contacting the Poison Help line (1-800-222-12222) or a medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using 3 H labeled drug, temazepam was well absorbed and found to have minimal (8%) first pass metabolism. There were no active metabolites formed and the only significant metabolite present in blood was the O-conjugate. The unchanged drug was 96% bound to plasma proteins.
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 method of determination. Metabolites were formed with a half-life of 10 hours and excreted with a half-life of approximately 2 hours. Thus, formation of the major metabolite is the rate limiting step in the biodisposition of temazepam.
There is no accumulation of metabolites. A dose-proportional relationship has been established for the area under the plasma concentration/time curve over the 15 to 30 mg dose range. Temazepam was completely metabolized through conjugation prior to excretion; 80% to 90% of the dose appeared in the urine.
The major metabolite was the O-conjugate of temazepam (90%); the O-conjugate of N-desmethyl temazepam was a minor metabolite (7%). Bioavailability, Induction, and Plasma Levels Following ingestion of a 30 mg temazepam capsule, measurable plasma concentrations were achieved 10 to 20 minutes after dosing with peak plasma levels ranging from 666 to 982 ng/mL (mean 865 ng/mL) occurring approximately 1.2 to 1.6 hours (mean 1.5 hours) after dosing. In a 7 day study, in which subjects were given a 30 mg temazepam capsule 1 hour before retiring, steady-state (as measured by the attainment of maximal trough concentrations) was achieved by the third dose.
Mean plasma levels of temazepam (for days 2 to 7) were 260±210 ng/mL at 9 hours and 75±80 ng/mL at 24 hours after dosing. A slight trend toward declining 24 hour plasma levels was seen after day 4 in the study, however, the 24 hour plasma levels were quite variable. At a dose of 30 mg once-a-day for 8 weeks, no evidence of enzyme induction was found in man.
Elimination Rate of Benzodiazepine Hypnotics and Profile of Common Untoward Effects The type and duration of hypnotic effects and the profile of unwanted effects during administration of benzodiazepine hypnotics may be influenced by the biologic half-life of the administered drug and for some hypnotics, the half-life of any active metabolites formed. Benzodiazepine hypnotics have a spectrum of half-lives from short (<4 hours) to long (>20 hours). When half-lives are long, drug (and for some drugs their active metabolites) may accumulate during periods of nightly administration and be associated with impairments of cognitive and/or motor performance during waking hours; the possibility of interaction with other psychoactive drugs or alcohol will be enhanced.
In contrast, if half-lives are shorter, drug (and, where appropriate, its active metabolites) will be cleared before the next dose is ingested, and carry-over effects related to excessive sedation or CNS depression should be minimal or absent. However, during nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of benzodiazepine hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug, or, if appropriate, its active metabolites (i.e., in relationship to the receptor site) may occur at some point in the interval between each night’s use.
This sequence of events may account for 2 clinical findings reported to occur after several weeks of nightly use of rapidly eliminated benzodiazepine hypnotics, namely, increased wakefulness during the last third of the night, and the appearance of increased signs of daytime anxiety. Controlled Trials Supporting Efficacy Temazepam improved sleep parameters in clinical studies. Residual medication ef…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Temazepam capsules, USP 7.5 mg are hard gelatin capsules with white opaque body printed radially “583” with black ink and blue opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-583-03 Bottles of 100: NDC 65162-583-10 Bottles of 500: NDC 65162-583-50 Bottles of 1000: NDC 65162-583-11 Temazepam capsules, USP 15 mg are hard gelatin capsules with white opaque body printed radially “556” with black ink and blue green opaque cap printed radially “AMNEAL” with black ink.
They are available as follows: Bottles of 30: NDC 65162-556-03 Bottles of 100: NDC 65162-556-10 Bottles of 500: NDC 65162-556-50 Bottles of 1000: NDC 65162-556-11 Temazepam capsules, USP 22.5 mg are hard gelatin capsules with white opaque body printed radially “584” with black ink and dark pink opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-584-03 Bottles of 100: NDC 65162-584-10 Bottles of 500: NDC 65162-584-50 Bottles of 1000: NDC 65162-584-11 Temazepam capsules, USP 30 mg are hard gelatin capsules with white opaque body printed radially “557” with black ink and white opaque cap printed radially “AMNEAL” with black ink.
They are available as follows: Bottles of 30: NDC 65162-557-03 Bottles of 100: NDC 65162-557-10 Bottles of 500: NDC 65162-557-50 Bottles of 1000: NDC 65162-557-11 Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev.
02-2023-05
📋 Description ▾
DESCRIPTION Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is: C 16 H 13 ClN 2 O 2 MW = 300.74 Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.
Each capsule for oral administration contains either 7.5 mg, 15 mg, 22.5 mg or 30 mg temazepam, USP. The inactive ingredients include: ammonia, black iron oxide, butyl alcohol, croscarmellose sodium, dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Additionally, the 7.5 mg capsule contains D&C Red #28 and FD&C Blue #1 and the 15 mg and 22.5 mg capsules contain FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6.
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💬 Medication Guide ▾
MEDICATION GUIDE Temazepam (tem az’ e pam) Capsules, USP CIV What is the most important information I should know about temazepam capsules? Temazepam capsules are 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: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking temazepam capsules and opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including temazepam capsules which can lead to overdose and serious side effects including coma and death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including temazepam capsules. 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.
You can develop an addiction even if you take temazepam capsules as prescribed by your healthcare provider Take temazepam capsules exactly as your healthcare provider prescribed. Do not share your temazepam capsules with other people. Keep temazepam capsules in a safe place and away from children.
Physical dependence and withdrawal reactions. Temazepam capsules can cause physical dependence and withdrawal reactions. Do not suddenly stop taking temazepam capsules.
Stopping temazepam capsules suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. Do not take more temazepam capsules than prescribed or take temazepam capsules for longer than prescribed.
After taking temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam capsules.
Reported activities include: driving a car (“sleep-driving”) making and eating food talking on the phone having sex sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules. What are temazepam capsules? Temazepam capsules are a prescription sleep medicine.
Temazepam capsules are used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night. Temazepam capsules are a federal controlled substance (CIV) because it contains temazepam that can be abused or…