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Temazepam

Temazepam is a benzodiazepine sleep medicine taken by mouth as a capsule for the short-term treatment of insomnia, generally for 7 to 10 days.

Brand name Restoril
Drug class Benzodiazepine
Rx Schedule CIV Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 60 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Temazepam at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Temazepam (Restoril) is a benzodiazepine sleep medicine that slows activity in the brain to treat short-term insomnia, generally for 7 to 10 days; on the market since the early 1980s and available as a generic, it is an older standby that is usually not the first choice now. Most people tolerate it well, and the effects they notice are drowsiness, dizziness or a next-day “hangover” feeling. Its boxed warning, the FDA’s strongest, covers deep sedation, slowed breathing, coma and death when combined with opioids, plus misuse, addiction and physical dependence. Skip alcohol, and after regular use never stop suddenly, since withdrawal can be life-threatening and needs a slow taper your prescriber plans.

Clinical pearls

  • Take it right at bedtime, and only when you can stay in bed for a full night, to limit next-day grogginess.
  • Over-the-counter sleep aids often contain sedating antihistamines, which stack on top of temazepam, so do not double up.
  • Before any surgery or dental work, tell the team you take it, because anesthetics add to its sedating effect.
  • As a Schedule IV controlled substance, refills are limited by law, so store it locked away from others in the home.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Temazepam has a boxed warning, the FDA's strongest warning, for three serious risks.

  • Opioids: taking it with opioids can cause profound sedation, slowed breathing, coma and death. It should be combined only when no other options work, at the lowest amounts and shortest time.
  • Abuse, misuse and addiction: these can lead to overdose or death. The risk is higher when it is mixed with other medicines, alcohol or illicit substances.
  • Dependence and withdrawal: your body can become physically dependent. Stopping suddenly or cutting back too fast can cause life-threatening withdrawal. Longer use and higher amounts raise the risk, so your prescriber should taper you slowly.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record1981
Companies listing it with the FDA22
FDA label last updatedNov 13, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Temazepam, written from its FDA label.

What Temazepam is used for

▾

Temazepam is used for one main purpose across the supported products.

  • Short-term treatment of insomnia, generally 7 to 10 days (Restoril capsules and Temazepam Capsules, USP, taken by mouth).

How Temazepam works

▾

Temazepam is a benzodiazepine sedative-hypnotic. It slows activity in the central nervous system, which helps you fall asleep and stay asleep. In sleep lab studies it improved total sleep time and shortened the time to fall asleep.

Temazepam dosage

▾

Temazepam is taken by mouth as a capsule, shortly before bed. It is meant for short periods, generally 7 to 10 days. Follow your prescriber and the label.

  • Older or debilitated people usually start on the lowest amount.
  • If you've used it for a while, stop only with a gradual taper your prescriber plans.

Dosing details from the FDA-approved label

From the Temazepam prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Usual adult dose
    • 15 mg before retiring
    • 7.5 mg may be sufficient for some patients, and others may need 30 mg
  • Transient insomnia
    • A 7.5 mg dose may be sufficient to improve sleep latency
  • Elderly or debilitated patients
    • Initiate therapy with 7.5 mg until individual responses are determined
    • Applies to elderly or debilitated patients
  • Discontinuation or dosage reduction
    • Use a gradual taper to discontinue or reduce the dosage
    • If withdrawal reactions develop, consider pausing the taper or increasing the dosage to the previous tapered dosage level, then decrease the dosage more slowly
    • To reduce the risk of withdrawal reactions
Read the label’s full dosing text

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 Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules 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 ).

Read the full Dosage and Administration section on DailyMed →

Temazepam side effects

▾

Side effects in studies were usually mild and short-lived. The most common were:

Common side effects

  • Drowsiness
  • Headache
  • Fatigue
  • Dizziness
  • Lethargy (low energy)
  • Nervousness
  • Nausea
  • Next-day “hangover” feeling

When to get medical help

  • Get emergency help if your tongue, throat or voice box swells, or you have trouble breathing. These can be signs of a severe allergic reaction. Do not take it again.
  • Get help right away for very slow or shallow breathing, extreme sleepiness or trouble waking up, especially if you also take opioids or drink alcohol.
  • Call your doctor if you do things while not fully awake, such as driving, cooking, eating or making phone calls, and don't remember them.
  • Tell your doctor about new or worrying changes in thinking or behavior, such as agitation, hallucinations or unusual aggressiveness.
  • Tell your doctor right away if you feel worse depressed or have thoughts of suicide.
  • Seek urgent care for seizures or severe symptoms after stopping or cutting back.
  • Call your doctor if insomnia doesn't improve after 7 to 10 days or gets worse. It may point to another medical or mental health problem.

Temazepam warnings and precautions

▾
  • Opioids and other sedatives: can cause dangerous slowed breathing, coma and death.
  • Abuse, misuse and addiction: can lead to overdose or death.
  • Dependence and withdrawal: stopping suddenly can cause life-threatening reactions such as seizures. Some people have withdrawal symptoms lasting weeks to over a year.
  • Complex sleep behaviors: sleep-driving and other activities with no memory of them. Stopping temazepam should be strongly considered after a sleep-driving episode.
  • Mood and behavior changes, memory loss, and falls, especially in older adults.
  • Severe allergic reactions: rare swelling of the tongue or throat.

Temazepam interactions

▾

Temazepam adds to the effects of other sedating substances.

  • Opioids: raise the risk of slowed breathing and death.
  • Alcohol: adds to sedation and raises the risk of sleep-driving.
  • Other CNS depressants (barbiturates, antipsychotics, sleep and anti-anxiety medicines, antidepressants, sedating antihistamines, seizure medicines, anesthetics): additive sedation.
  • Flumazenil: can trigger withdrawal and seizures.

Interactions listed in the FDA-approved label

From the Temazepam prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Opioids: Concomitant use increases the risk of respiratory depression, and benzodiazepines can significantly worsen opioid-related respiratory depression. Limit dosage and duration of concomitant use, and monitor patients closely for respiratory depression and sedation.
  • Other CNS depressants (alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, anesthetics): Benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered.
  • Cimetidine: The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.
Read the label’s full interactions text

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 benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics. The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Temazepam

▾
  • Tell your prescriber about all opioids, alcohol and sedating medicines you take.
  • Mention any history of substance misuse or addiction.
  • Mention depression or other mental health conditions.
  • Older adults are at higher risk of falls and confusion.
  • Tell your prescriber if you are pregnant. Use late in pregnancy can cause sedation or withdrawal in newborns.
  • Don't take it again if you had tongue or throat swelling on it.

Temazepam overdose

▾

Too much can cause central nervous system depression, from drowsiness and confusion to unsteadiness, coma and slowed breathing. Mixing it with alcohol or opioids can be fatal. Seek emergency care or call Poison Help right away. Treatment is mainly supportive care, such as fluids and airway management.

What Temazepam does in the body

▾

In sleep lab studies, temazepam improved total sleep time and how fast people fell asleep. REM sleep stayed about the same, and slow wave sleep decreased. Daytime alertness and performance were not measurably affected.

How your body processes Temazepam

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Temazepam is well absorbed, with levels measurable 10 to 20 minutes after a capsule and peaking at about 1.5 hours. Its average terminal half-life is about 8.8 hours. It is fully broken down by the body into inactive products, and 80% to 90% of a dose appears in the urine.

How to store Temazepam

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Dispense in a well-closed, light-resistant container. Store at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

197

Supplements & herbs that interact with Temazepam

197 supplements and herbal products have documented interactions with Temazepam in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 150
  • Minor · 38
Every supplement checked against Temazepam — ranked by severity The full interaction hub: 9 major · 150 moderate · 38 minor · every one linked to its full report. Check Temazepam against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Temazepam: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Temazepam — the kind of thing our pharmacy team would talk through with you at the counter.

What is temazepam for?

▾
It treats short-term insomnia, meaning trouble falling or staying asleep. It's generally meant for just 7 to 10 days. If your sleep isn't better by then, talk with your doctor, since something else may be going on.

How should I take it?

▾
Take it by mouth as a capsule right before bed, exactly as prescribed. Don't take more than directed. If you've been on it for a while, don't stop suddenly. Your prescriber should help you taper slowly.

What side effects should I expect?

▾
The most common are drowsiness, headache, tiredness, dizziness, low energy, nervousness and nausea. Most are mild and short-lived. Call your doctor for unusual behavior, memory gaps, or worsening mood.

Can I have a drink or take other medicines with it?

▾
Avoid alcohol. It adds to the sedation and raises the risk of sleep-driving. Tell me about any opioids or other sedating medicines, because combining them can slow breathing dangerously.

What is sleep-driving and should I worry?

▾
Some people on sleep medicines get up and do things like drive, cook or make calls while not fully awake, and don't remember it. It's uncommon but serious. If it happens, tell your doctor right away.

Is it safe in pregnancy?

▾
Using it late in pregnancy can cause sedation and withdrawal symptoms in newborns. If you're pregnant or planning to be, talk with your prescriber before taking it.

Is Temazepam available over the counter?

▾
No. Temazepam is a prescription medicine: every Temazepam product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Temazepam a controlled substance?

▾
Yes — Temazepam is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Temazepam first available?

▾
The earliest FDA record we hold for Temazepam is from 1981: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Temazepam was first used.

Who makes Temazepam?

▾
22 companies currently list Temazepam products in the FDA's NDC Directory, including Bryant Ranch Prepack, SpecGx LLC, Aphena Pharma Solutions - Tennessee, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Temazepam on HelloPharmacist

Detailed data & references for Temazepam Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Temazepam forms and strengths (how it comes)

Temazepam is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Restoril
How this form is used
What it may be used for
  • Restoril capsules are used for short-term treatment of insomnia, generally 7 to 10 days.
  • Temazepam Capsules, USP are used for short-term treatment of insomnia, generally 7 to 10 days.
Important instructions
  • Restoril is taken by mouth before bedtime, for a short period as directed.
  • Temazepam Capsules, USP are taken by mouth before bedtime, for a short period as directed.
  • For Restoril and Temazepam Capsules, USP, older or debilitated patients are started on the lowest amount.
  • For Restoril and Temazepam Capsules, USP, a gradual taper is used to stop or lower the dose.
Available strengths 4 strengths
201 FDA-listed product records ⓘ

Temazepam on the U.S. market: products, makers and brands

How Temazepam appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

22 companies list 88 Temazepam product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1981. Brand names on the directory include Restoril; the rest are generics.

1
Dose forms ⓘ
22
Labelers (makers, repackagers, distributors)
2
Brand names
88
FDA-listed product records ⓘ
1981
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack24%
SpecGx LLC9%
Aphena Pharma Solutions - Tennessee, LLC8%
Alembic Pharmaceuticals Inc.5%
Alembic Pharmaceuticals Limited5%
Amneal Pharmaceuticals LLC5%
Other makers45%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Temazepam is used (Medicaid data)

A general measure of how commonly Temazepam is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Temazepam is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

303,646
Medicaid prescriptions filled (Q1–Q4 2025)
$2.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Temazepam prescribed? Of the 1,601 medications we measure, Temazepam ranks #319 by Medicaid prescriptions — more than 80% of them.

Where Temazepam ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Temazepam product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 30 mg oral capsule is the most-dispensed Temazepam product — about 63% of these Medicaid prescriptions.

temazepam 30 MG Oral Capsule Most dispensed

191,914 Medicaid prescriptions (Q1–Q4 2025) 63% of Temazepam prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $8.72 per prescription (gross)

Summed across the 6 of 162 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198242

temazepam 15 MG Oral Capsule

101,849 Medicaid prescriptions (Q1–Q4 2025) 34% of Temazepam prescriptions shown $870,224 gross reimbursement (before rebates) ≈ $8.54 per prescription (gross)

Summed across the 7 of 167 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198241

temazepam 7.5 MG Oral Capsule

7,926 Medicaid prescriptions (Q1–Q4 2025) 3% of Temazepam prescriptions shown $272,446 gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 3 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198243

temazepam 22.5 MG Oral Capsule

1,957 Medicaid prescriptions (Q1–Q4 2025) <1% of Temazepam prescriptions shown $119,309 gross reimbursement (before rebates) ≈ $61 per prescription (gross)

Summed across the 3 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485489

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Temazepam, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 407 listed Temazepam NDCs with Medicaid activity.

Compare Temazepam products

A representative set of FDA-listed product records for Temazepam — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 88 of 88 products — FDA National Drug Code Directory. See every product, package size and price: browse all 88 Temazepam NDCs →

Temazepam recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Temazepam recalls since July 2021.

✅No Temazepam recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Temazepam RxCUI 10355 3 dose forms · 7 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 374026 In current FDA listings
    Clinical drug / strength (SCD) 7.5 MG RxCUI 198243 15 MG RxCUI 198241 22.5 MG RxCUI 485489 30 MG RxCUI 198242
  2. Dose form (SCDF) Oral Solution RxCUI 380896 No current FDA listing
    Clinical drug / strength (SCD) 2 MG/ML RxCUI 151283
  3. Dose form (SCDF) Oral Tablet RxCUI 374028 No current FDA listing
    Clinical drug / strength (SCD) 10 MG RxCUI 199975 20 MG RxCUI 104693

Look up RxCUI 10355 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Temazepam costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 30 mg $0.089 per capsule NDC details & price history
Capsule · Oral 15 mg $0.077 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Temazepam brand names

Temazepam is sold under one brand name in the FDA directory — Restoril. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Restoril

Who makes Temazepam: manufacturers and labelers

22 companies list Temazepam products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, SpecGx LLC, Aphena Pharma Solutions - Tennessee, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 21 SpecGx LLC 8 Aphena Pharma Solutions - Tennessee, LLC 7 Alembic Pharmaceuticals Inc. 4 Alembic Pharmaceuticals Limited 4 Amneal Pharmaceuticals LLC 4 Ascend Laboratories, LLC 4 Asclemed USA, Inc. 4 Proficient Rx LP 4 Solco Healthcare U.S., LLC 4 PD-Rx Pharmaceuticals, Inc. 3 Preferred Pharmaceuticals Inc. 3 A-S Medication Solutions 2 Actavis Pharma, Inc. 2 Advanced Rx Pharmacy of Tennessee, LLC 2 Amneal Pharmaceuticals of New York LLC 2 AvPAK 2 Golden State Medical Supply, Inc. 2 NuCare Pharmaceuticals,Inc. 2 Remedyrepack Inc. 2 American Health Packaging 1 Major Pharmaceuticals 1

Temazepam drug class (RxNorm)

Temazepam belongs to the Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Temazepam page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 13, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Temazepam.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Temazepam after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
60
Finished products in the current FDA directory
88
Companies listing them (makers, repackagers, distributors)
22
FDA labeler codes behind them ⓘ
29
Linked representative label ⓘ
American Health Packaging
Linked label effective
Nov 13, 2025
Composite sections available
20
Linked SPL Set ID
a3f06243-fa03-4cbd-951a-144ec43dcdfd
Linked SPL Document ID
437ec164-740f-2419-e063-6294a90a17e6
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. American Health Packaging is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →