Temazepam 7.5 mg Capsule, 30-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:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 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 | $4.90 / 30 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Temazepam 7.5 mg 00406-9960-01 | SpecGx | 100 capsules | $0.954 | AB | Availability likely | — |
| Temazepam 7.5 mg 00904-6436-04 | Major | 30 capsules | $0.954 | AB | Availability likely | — |
| Temazepam 7.5 mg 43547-0611-10 | Solco | 100 capsules | $0.954 | AB | Availability likely | — |
| temazepam 7.5 mg 67877-0148-01 | Ascend | 100 capsules | $0.954 | AB | Availability likely | — |
| Temazepam 7.5 mg 68084-0549-21 | American | 30 capsules | $0.954 | AB | Availability likely | — |
| Restoril 7.5 mg 00406-9915-01 | SpecGx | 100 capsules | — | AB | FDA listed | — |
| Temazepam 7.5 mgthis 43353-0152-30 | Aphena | 30 capsules | — | AB | Discontinued | — |
| Temazepam 7.5 mg 46708-0379-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Temazepam 7.5 mg 62332-0379-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| temazepam 7.5 mg 63629-8601-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| Temazepam 7.5 mg 65162-0583-03 | Amneal | 30 capsules | — | AB | FDA listed | — |
| Temazepam 7.5 mg 71610-0004-30 | Aphena | 30 capsules | — | AB | FDA listed | — |
| temazepam 7.5 mg 72162-1826-01 | Bryant | 100 capsules | — | AB | FDA listed | — |
| temazepam 7.5 mg 76420-0472-01 | Asclemed | 100 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 |
|---|---|---|---|
| 43353-0152-30 You're viewing this | 30 CAPSULE in 1 BOTTLE (43353-152-30) | 2016-02-22 | Discontinued by firm |
| 43353-0152-53 | 60 CAPSULE in 1 BOTTLE (43353-152-53) | 2016-04-29 | Discontinued by firm |
| 43353-0152-60 | 90 CAPSULE in 1 BOTTLE (43353-152-60) | 2016-02-16 | Discontinued by firm |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 43353-0152-30?
What is the difference between NDC 43353-0152-30 and NDC 43353-0152-53?
What NDC number is used to bill for this package of Temazepam 7.5 mg Capsule?
🧭 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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND 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, USP 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.
⛔ 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 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 origin, or a result of an underlying psychiatric or physical disorder.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE ).
🤒 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%).
🆘 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 LD 50 of temazepam was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits.
🧬 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%).
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Temazepam Capsules USP 7.5 mg Pink opaque cap and white opaque body, imprinted “7.5 mg” on cap and “Novel 120” on the body in black ink. Unit dose box of 30........NDC 0904-6436-04 Bottle of 100 ……..NDC 0904-6436-60 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 Medical Economics Company, Inc.
Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Distributed by: MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA
📋 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, USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration.
7.5mg, 15 mg, 22.5 mg and 30 mg Capsules Active Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 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.
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.
22.5mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, 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.
C:\Documents and Settings\spolina\desktop\tem-spl\STRUCTURE.JPG
💬 Medication Guide ▾
Medguide TEMAZEPAM Capsules, USP C-IV (temazepam) Read the Medication Guide that comes with TEMAZEPAM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about TEMAZEPAM? 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: • driving a car (“sleep-driving”) • making and eating food • talking on the phone • having sex • sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking TEMAZEPAM. Important: 1.
Take TEMAZEPAM exactly as prescribed 2. Do not take more TEMAZEPAM than prescribed. 3.
Take TEMAZEPAM right before you get in bed, not sooner. 4. Do not take TEMAZEPAM if you: • drink alcohol • take other medicines that can make you sleepy.
Talk to your doctor about all of your medicines. Your doctor will tell you if you can take TEMAZEPAM with your other medicines • cannot get a full night’s sleep What is TEMAZEPAM? TEMAZEPAM is a sedative-hypnotic (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 • waking up often during the night TEMAZEPAM is not for children. TEMAZEPAM is a federally 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 doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take TEMAZEPAM? Do not take TEMAZEPAM if you are pregnant or planning to become pregnant. TEMAZEPAM may cause birth defects or harm a fetus (unborn baby).
TEMAZEPAM may not be right for you. Before starting TEMAZEPAM, tell your doctor about all of your health 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 kidney or liver disease • have a lung disease or breathing problems • are breastfeeding Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.
Do not take TEMAZEPAM with other medicines that can make you sleepy. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take TEMAZEPAM? • Take TEMAZEPAM exactly as prescribed. Do not take more TEMAZEPAM than prescribed for you. • 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. • Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. • If you take too much TEMAZEPAM or overdose, call your doctor or poison control center right away, or get emergency treatment.
What are the possible side effects of TEMAZEPAM? Possible serious side effects of TEMAZEPAM include: • getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about TEMAZEPAM?”) • abnormal thoughts and behavior.
Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression…