temazepam 15 mg Capsule, 120-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
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🩺 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 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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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 H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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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 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 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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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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.
16 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
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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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 | $19.58 / 120 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Temazepam 15 mg 00228-2076-10 | Actavis | 100 capsules | $0.079 | AB | Availability likely | — |
| Temazepam 15 mg 00406-9961-01 | SpecGx | 100 capsules | $0.079 | AB | Availability likely | — |
| Temazepam 15 mg 43547-0612-10 | Solco | 100 capsules | $0.079 | AB | Availability likely | — |
| temazepam 15 mg 50268-0779-15 | AvPAK | 50 capsules | $0.079 | AB | Availability likely | — |
| Temazepam 15 mg 53746-0556-01 | Amneal | 100 capsules | $0.079 | AB | Availability likely | — |
| temazepam 15 mg 67877-0146-01 | Ascend | 100 capsules | $0.079 | AB | Availability likely | — |
| Restoril 15 mg 00406-9916-01 | SpecGx | 100 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 43353-0312-15 | Aphena | 15 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 46708-0380-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 50090-0186-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 51407-0507-05 | Golden | 500 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 55289-0196-01 | PD-Rx | 100 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 62332-0380-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 63187-0132-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 63629-1619-01 | Bryant | 20 capsules | — | AB | Discontinued | — |
| temazepam 15 mg 63629-8602-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 63629-8603-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 65162-0556-03 | Amneal | 30 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 67544-0136-10 | Aphena | 10 capsules | — | — | FDA listed | — |
| temazepam 15 mg 68788-8139-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 68788-8493-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 70518-0647-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 70518-2487-00 | REMEDYREPACK | 100 capsules | — | AB | Discontinued | — |
| temazepam 15 mgthis 71205-0914-72 | Proficient | 120 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 71335-0315-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 71335-2900-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 71335-9741-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 71610-0625-15 | Aphena | 15 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 72162-1824-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| temazepam 15 mg 76420-0473-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Temazepam 15 mg 80425-0191-02 | 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 | Marketing start | Status |
|---|---|---|---|
| 71205-0914-00 | 100 CAPSULE in 1 BOTTLE (71205-914-00) | 2021-07-14 | Active |
| 71205-0914-30 | 30 CAPSULE in 1 BOTTLE (71205-914-30) | 2021-07-14 | Active |
| 71205-0914-55 | 500 CAPSULE in 1 BOTTLE (71205-914-55) | 2021-07-14 | Active |
| 71205-0914-60 | 60 CAPSULE in 1 BOTTLE (71205-914-60) | 2021-07-14 | Active |
| 71205-0914-72 You're viewing this | 120 CAPSULE in 1 BOTTLE (71205-914-72) | 2021-07-14 | Active |
| 71205-0914-90 | 90 CAPSULE in 1 BOTTLE (71205-914-90) | 2021-07-14 | Active |
You're viewing one of 6 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71205-0914-72?
What is the difference between NDC 71205-0914-72 and NDC 71205-0914-30?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and Drug Interactions). • Reserve concomitant prescribing of these drugs for use 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.
🎯 Indications and Usage ▾
INDICATIONS & USAGE Temazepam Capsules, USP 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 & 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.
Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher.
In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls.
Temazepam is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant.
The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.
⚠️ Warnings ▾
WARNINGS 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 for use 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 Drug Interactions ). Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder.
Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior.
Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class. Because some of the worrisome adverse effects of benzodiazepines, including temazepam, appear to be dose related ( see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), it is important to use the lowest possible effective dose. Elderly patients are especially at risk.
Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol. Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.
These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with temazepam alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam appears to increase the risk of such behaviors, as does the use of temazepam at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of temazepam should be strongly considered for patients who report a “sleep-driving” episode.
Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia and other neuro-psychiatric symptoms may occur unpredictably.
In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origi…
🤒 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%).
🔄 Drug Interactions ▾
Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.
🤰 Pregnancy ▾
Pregnancy (see CONTRAINDICATIONS).
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of Temazepam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy commonly observed in this population.
Temazepam 7.5 mg is recommended as the initial dosage for patient aged 65 and over since the risk of the development of oversedation, dizziness, confusion, ataxia and/or falls increases substantially with larger doses of benzodiazepines in elderly and debilitated patients.
🆘 Overdosage ▾
OVERDOSAGE Manifestations of acute overdosage of temazepam can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. The oral LD50 of temazepam was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits. Treatment If the patient is conscious, vomiting should be induced mechanically or with emetics.
Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications. Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension.
Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used.
It should be borne in mind that multiple agents may have been ingested. Flumazenil (Romazicon ® ) * , a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access.
Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.
The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use. Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk References ®** .
🧬 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 15 mg Blue opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottle of 30 NDC 71205-914-30 Bottle of 60 NDC 71205-914-60 Bottle of 90 NDC 71205-914-90 Bottle of 100 NDC 71205-914-00 Bottle of 120 NDC 71205-914-72 Bottle of 500 NDC 71205-914-55 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 30 NDC 71205-915-30 Bottle of 60 NDC 71205-915-60 Bottle of 90 NDC 71205-915-90 Bottle of 100 NDC 71205-915-00 Bottle of 120 NDC 71205-915-72 Bottle of 500 NDC 71205-915-55 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]. *Romazicon is the registered trademark of Hoffman-LaRoche Inc. **Trademark of PDR Network, LLC Manufactured by: Novel Laboratories Inc. Somerset, NJ 08873 Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320
📋 Description ▾
DESCRIPTION Temazepam 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 is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 15 mg and 30 mg are for oral administration.
15 mg and 30 mg Capsules Active Ingredient: temazepam USP 15 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.
30 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. temazepam-str
💬 Information for Patients ▾
Information for Patients The text of a patient Medication Guide is printed at the end of this insert. To assure safe and effective use of temazepam, the information and instructions provided in this patient Medication Guide should be discussed with patients. Special Concerns “Sleep-Driving” and Other Complex Behaviors - There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event.
If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when temazepam is taken with alcohol or other central nervous system depressants ( see WARNINGS ). Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
As with "sleep-driving", patients usually do not remember these events. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.
💬 Medication Guide ▾
MEDICATION GUIDE TEMAZEPAM (tem az' e pam) Capsules, C-IV What is the most important information I should know about TEMAZEPAM? • TEMAZEPAM is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. • After taking TEMAZEPAM, 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. Reported activities include: o driving a car (“sleep-driving”) o making and eating food o talking on the phone o having sex o sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking TEMAZEPAM. • Do not take TEMAZEPAM unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. • Do not take more TEMAZEPAM than prescribed.
What is TEMAZEPAM? • TEMAZEPAM is a prescription sleep medicine. TEMAZEPAM is 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 is a federal controlled substance (C-IV) because it can be abused or lead to dependence.
Keep TEMAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away TEMAZEPAM may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if TEMAZEPAM is safe and effective in children. • It is not known if TEMAZEPAM is safe and effective for use longer than 2 weeks.
Do not take TEMAZEPAM if you: • are allergic to temazepam or any of the ingredients in TEMAZEPAM. See the end of this Medication Guide for a complete list of ingredients in TEMAZEPAM. Before you take TEMAZEPAM, tell your healthcare provider about all of your medical conditions, including if you: • have a history of depression, mental illness or, suicidal thoughts • have a history of drug or alcohol abuse or addiction • have lung disease or breathing problems • are pregnant or plan to become pregnant.
TEMAZEPAM may cause birth defects or harm your unborn baby. • are breastfeeding, or plan to breastfeed. TEMAZEPAM may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take TEMAZEPAM.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TEMAZEPAM with certain other medicines can cause side effects or affect how well TEMAZEPAM or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
Do not take TEMAZEPAM with other medicines that can make you sleepy unless your healthcare provider tells you to. How should I take TEMAZEPAM? • See “What is the most important information I should know about TEMAZEPAM?” • Take TEMAZEPAM exactly as your healthcare providers tell you to take it. Take TEMAZEPAM right before you get into bed. • Do not take TEMAZEPAM unless you are able to get a full night’s sleep before you must be active again. • If you take too much TEMAZEPAM or overdose, get emergency treatment right away.
What should I avoid while taking TEMAZEPAM? • Do not drive, operate machinery, do other dangerous activities or do anything that needs you to be alert until you know how TEMAZEPAM affects you. • You should not drink alcohol while you are taking TEMAZEPAM. What are the possible side effects of TEMAZEPAM? TEMAZEPAM may cause serious side effects, including: • See “What is the most important…