Last updated: August 28, 2026
RESTORIL, the brand name for temazepam, is a mature prescription hypnotic with limited remaining brand value. The drug received FDA approval in 1981 and is now exposed primarily to generic competition, controlled-substance prescribing constraints, and declining use of benzodiazepines in older adults. No active Orange Book patent or meaningful regulatory exclusivity protects the product. Standalone Restoril revenue is not publicly disclosed, but its financial trajectory is best characterized as a low-revenue, low-growth legacy-brand market rather than an innovation-driven franchise.
What is RESTORIL and how is it used?
RESTORIL contains temazepam, a benzodiazepine indicated for the short-term treatment of insomnia. The FDA-approved product is available in 7.5 mg, 15 mg, 22.5 mg, and 30 mg capsules, although commercial availability can vary by manufacturer and pharmacy channel. Temazepam enhances gamma-aminobutyric acid activity through the benzodiazepine receptor complex, producing sedative and hypnotic effects.
The principal commercial alternatives are generic temazepam capsules and other insomnia medicines, including:
- Z-drugs such as zolpidem and eszopiclone
- Benzodiazepines such as triazolam and estazolam
- Orexin receptor antagonists such as suvorexant, lemborexant, and daridorexant
- Low-dose doxepin
- Melatonin-receptor agonist therapy
- Off-label sedating antidepressants and antipsychotics
RESTORIL is a Schedule IV controlled substance under the federal Controlled Substances Act. The label carries boxed warnings concerning abuse, misuse, addiction, dependence, and withdrawal risks. FDA labeling also warns about serious sedation and respiratory depression when benzodiazepines are combined with opioids. These restrictions affect prescribing volume, refill patterns, and payer management.[1]
When did RESTORIL lose exclusivity?
RESTORIL lost meaningful exclusivity many years ago. The product's NDA approval dates to 1981, and generic temazepam entered the market after the original brand protection period ended. Current commercial competition is therefore based on price, supply reliability, wholesaler access, and prescriber familiarity rather than patent differentiation.
| Exclusivity element |
RESTORIL status |
| Active ingredient |
Temazepam |
| FDA NDA |
NDA 017464 |
| Original FDA approval |
1981 |
| Regulatory exclusivity |
Expired |
| Patent exclusivity |
No current active Orange Book patent listed for Restoril |
| Generic competition |
Established |
| Controlled-substance status |
Schedule IV |
| Current commercial model |
Mature brand plus generic market |
The distinction between FDA exclusivity and patent protection is important. RESTORIL's market protection ended through the combined expiration of its original regulatory and patent rights. The product does not have a current new chemical entity, pediatric, orphan, or other active exclusivity period.
What patents protect RESTORIL today?
No active Orange Book patent is identified for RESTORIL in the FDA's current publication framework. The product therefore lacks an FDA-listed patent barrier against abbreviated new drug applications.
Formulation patents
The commercial product is a conventional oral capsule. There is no widely recognized active RESTORIL formulation patent protecting a differentiated extended-release system, abuse-deterrent platform, modified-release capsule, or proprietary delivery technology.
This limits the ability of the brand owner to extend market protection through lifecycle management. A conventional immediate-release capsule is relatively straightforward for generic manufacturers to reproduce, subject to applicable quality, bioequivalence, manufacturing, and controlled-substance requirements.
Method-of-use patents
No active method-of-use patent is identified as protecting RESTORIL's approved insomnia indication. The underlying therapeutic use of temazepam is longstanding, and the FDA label does not create a commercially relevant exclusivity period.
Any later patent claims directed to a narrow patient population, dosing regimen, combination, or treatment protocol would need to satisfy patentability, written-description, enablement, and infringement requirements. Such claims would also face practical limitations because temazepam is an old, widely used benzodiazepine.
Manufacturing and process protection
Manufacturing know-how may still provide operational value, particularly for controlled-substance inventory management, impurity control, capsule filling, packaging, and supply continuity. That know-how is different from an enforceable product-market patent. It does not prevent approved generic manufacturers from competing if they can independently meet FDA quality and manufacturing requirements.
What is the Orange Book status of RESTORIL?
The key Orange Book conclusion is that RESTORIL does not have an active listed patent blocking generic approval. FDA Orange Book records distinguish the reference-listed drug from any associated patent or exclusivity information. For a mature temazepam product, the commercial relevance of the listing is the continued reference-product role, not patent-based market protection.[2]
The likely regulatory structure is:
- RESTORIL remains the reference brand product associated with its approved NDA.
- Generic temazepam products are approved through ANDAs.
- No current Orange Book patent creates a meaningful Paragraph IV barrier.
- Generic substitution is generally permitted under state pharmacy laws, subject to product-specific substitution rules and payer policy.
- Controlled-substance prescribing and dispensing rules continue to apply to both brand and generic products.
Are generic manufacturers challenging RESTORIL through Paragraph IV filings?
A current Paragraph IV campaign against RESTORIL is not commercially material because no active Orange Book patent appears to block generic temazepam approval. Generic temazepam has already entered the market, making the relevant patent challenge period historical rather than current.
Paragraph IV certifications are most consequential when a branded product has an unexpired listed patent. In RESTORIL's case, generic competition is established and the drug is no longer in a conventional patent-defense cycle. The competitive question is therefore not whether a generic applicant can enter, but how many generic suppliers remain active and whether they can maintain reliable supply.
How strong is the RESTORIL patent estate?
RESTORIL has a weak current patent estate.
| Patent-estate factor |
Assessment |
| Active composition-of-matter patent |
None identified |
| Active Orange Book patent |
None identified |
| Active formulation patent |
None identified |
| Active method-of-use patent |
None identified |
| Generic entry barrier |
Low |
| Manufacturing complexity |
Low to moderate |
| Controlled-substance compliance burden |
Moderate |
| Brand pricing power |
Low |
| Litigation leverage |
Low |
The remaining barriers are regulatory and operational rather than intellectual-property based. Manufacturers must comply with FDA current good manufacturing practice requirements, maintain controlled-substance registrations and quotas, manage diversion controls, and satisfy pharmacovigilance obligations. Those requirements can affect supply but do not create durable exclusivity.
What is the competitive landscape for temazepam?
The temazepam market is fragmented and price-sensitive. Generic suppliers compete for contracts with wholesalers, retail pharmacies, hospitals, long-term-care providers, and government purchasers. Brand RESTORIL competes against generic temazepam on perceived reliability, prescriber recognition, and patient preference, but these advantages are limited for a product with no active exclusivity.
The strongest competitive pressure comes from substitution at the therapeutic-class level. Prescribers may choose zolpidem, eszopiclone, suvorexant, lemborexant, doxepin, or nonpharmacologic insomnia treatment instead of temazepam. The American Geriatrics Society Beers Criteria identify benzodiazepines as potentially inappropriate for many older adults because of risks including cognitive impairment, delirium, falls, fractures, and motor-vehicle crashes.[3]
Temazepam can retain demand among patients with prior response, established prescriber preference, or limited tolerance of alternative hypnotics. Its use is constrained by:
- Dependence and withdrawal risk
- Age-related sensitivity
- Opioid and alcohol interaction risk
- State-level prescribing controls
- Institutional benzodiazepine reduction programs
- Increased use of cognitive behavioral therapy for insomnia
- Payer preference for lower-cost generics
What is the financial trajectory for RESTORIL?
RESTORIL's financial trajectory is mature to declining in nominal brand terms, with no public evidence of a new growth catalyst. Standalone Restoril sales are not reported separately by the major commercial entities associated with the product, so a defensible product-level revenue figure cannot be established from public company filings.
The economic profile is clearer than the exact revenue number:
| Financial driver |
Likely effect |
| Generic substitution |
Reduces brand volume and price |
| No active patents |
Prevents premium pricing and exclusivity extension |
| Controlled-substance demand |
Supports stable but restricted utilization |
| Older-patient safety concerns |
Pressures long-term prescribing |
| Retail pharmacy distribution |
Supports broad access |
| Low manufacturing complexity |
Enables supplier competition |
| Brand recognition |
Provides residual demand |
| Payer formularies |
Favor generic temazepam |
RESTORIL's revenue exposure is therefore likely concentrated in residual branded prescriptions, cash-pay patients, prescribers that specify the brand, and patients who report differences between manufacturers. Generic temazepam captures most price-sensitive demand.
For a brand owner, the product may still generate cash flow if manufacturing, marketing, and distribution costs are low. The business case is unlikely to support major investment in new clinical trials, patent prosecution, or large-scale promotional spending without a new formulation or differentiated delivery platform.
What FDA regulatory risks affect RESTORIL?
FDA and public-health policy create more commercial pressure than patent law.
The principal regulatory and safety issues are:
- Benzodiazepine class warnings for abuse, misuse, addiction, dependence, and withdrawal.
- Risks of severe sedation and respiratory depression with opioids.
- Increased adverse-event risk in older adults.
- Restrictions on prescribing and dispensing controlled substances.
- Potential scrutiny of long-term use outside the short-term insomnia indication.
- Product-quality and supply-chain requirements for generic manufacturers.
FDA labeling recommends short-term use for insomnia, generally interpreted as seven to 10 days without reassessment when symptoms persist. Long-term use increases dependence and tolerance concerns and can expose prescribers and manufacturers to greater compliance risk.[1]
What generic launch scenarios exist for RESTORIL?
Because generic temazepam is already established, future launch scenarios concern additional supplier entry, re-entry after shortages, or product discontinuation rather than first generic launch.
Base case: stable generic supply
Multiple generic suppliers continue to compete, keeping prices low and limiting Restoril's volume. Brand sales decline gradually but remain available through selected pharmacies and prescribers.
Downside case: further brand erosion
Payers and pharmacies increase generic substitution, reducing brand prescriptions to a narrow residual segment. The brand becomes commercially marginal, especially if the manufacturer reduces promotion or distribution.
Supply-disruption case
A generic manufacturer exits or experiences quality problems, allowing temporary price increases or short-lived Restoril demand. This would be a supply event, not a restoration of durable market power.
Lifecycle-management case
A manufacturer develops a new temazepam formulation, packaging system, or delivery mechanism. Commercial success would depend on clinical differentiation and enforceable protection. A simple reformulation would face reimbursement and generic-substitution challenges.
What patent litigation or settlement agreements affect RESTORIL?
No active RESTORIL patent litigation or settlement agreement is identified as a current driver of market access in the FDA Orange Book framework. The product's major patent disputes, if any existed during the original generic-entry period, do not determine present-day competition.
The absence of an active patent dispute means:
- No 30-month stay tied to a current Paragraph IV certification is commercially central.
- No first-filer exclusivity period is protecting the brand.
- No settlement date is controlling generic entry.
- Generic manufacturers can compete under ordinary ANDA approval and commercial conditions.
How does RESTORIL compare with newer insomnia drugs?
| Product |
Active ingredient |
Protection profile |
Commercial position |
| RESTORIL |
Temazepam |
No active patent exclusivity identified |
Mature brand and generic market |
| Ambien |
Zolpidem |
Original protection expired; generic market |
Large established generic class |
| Lunesta |
Eszopiclone |
Original protection expired; generic market |
Generic and branded residual demand |
| BELSOMRA |
Suvorexant |
Newer branded product with patent-led protection |
Higher-price differentiated therapy |
| DAYVIGO |
Lemborexant |
Newer branded product with patent-led protection |
Premium branded insomnia segment |
| QUVIVIQ |
Daridorexant |
Newer branded product with patent-led protection |
Growth-oriented orexin antagonist |
The commercial distinction is between low-cost, genericized benzodiazepine therapy and newer orexin-based products that rely on clinical differentiation, active patents, and branded reimbursement strategies. RESTORIL has lower acquisition cost but a weaker long-term growth profile and more prominent dependence-related safety concerns.
What geographic markets remain commercially relevant?
The United States remains important because RESTORIL is an established FDA-approved brand and temazepam has a large generic infrastructure. International markets differ in brand status, controlled-substance classification, reimbursement, and availability. The Restoril name may not be used consistently outside the United States, and temazepam can be subject to stricter restrictions in some jurisdictions.
Geographic value is therefore driven by:
- Local approval and scheduling
- Generic competition
- Reimbursement
- Pharmacy distribution
- Controlled-substance quotas
- National benzodiazepine prescribing policy
A U.S. commercial assessment should not be extrapolated directly to Europe, Canada, or emerging markets.
Key Takeaways
- RESTORIL is the branded temazepam product approved by FDA in 1981.
- Its regulatory and patent exclusivity expired decades ago.
- No active Orange Book patent is identified as blocking generic temazepam competition.
- Paragraph IV litigation is not a current commercial barrier.
- Generic substitution is the principal source of brand erosion.
- Standalone Restoril revenue is not publicly disclosed.
- The financial trajectory is mature to declining, with residual cash-flow potential but limited growth.
- Safety warnings, controlled-substance rules, and geriatric prescribing concerns constrain demand.
- The largest competitive threat comes from generic temazepam and newer insomnia therapies, particularly orexin antagonists.
- Manufacturing and controlled-substance compliance can affect supply but do not create durable market exclusivity.
FAQs
Is RESTORIL still available by prescription?
Yes. RESTORIL remains an FDA-approved prescription product, although pharmacy availability and manufacturer distribution can vary. Generic temazepam is more commonly used because of lower cost.
Is temazepam a controlled substance?
Yes. Temazepam is a Schedule IV benzodiazepine in the United States and is subject to controlled-substance prescribing, dispensing, storage, and recordkeeping requirements.
Can a generic company launch temazepam without a patent settlement?
Yes. Established generic temazepam products already compete in the market, and no active Restoril patent settlement is required to authorize ordinary generic competition in the absence of a blocking patent.
Does RESTORIL have a pediatric or orphan-drug exclusivity period?
No current pediatric or orphan exclusivity period is identified for RESTORIL. Any original regulatory exclusivity has expired.
Could a new temazepam formulation obtain patent protection?
A genuinely novel formulation or delivery system could potentially qualify for patent protection if it satisfies statutory requirements. That protection would cover the qualifying formulation or use, not automatically restore exclusivity for conventional temazepam capsules.
References
-
U.S. Food and Drug Administration. (2020). RESTORIL (temazepam) capsules prescribing information. FDA.
-
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.
-
American Geriatrics Society Beers Criteria Update Expert Panel. (2023). American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society, 71(7), 2052-2081.
