Restoril

Treats insomnia (generally 7 to 10 days). NDA 18163, held by Specgx LLC. Temazepam.

As of Nov 14, 2026, NDA 18163 (Restoril), held by Specgx LLC, was first approved by FDA on Feb 27, 1981, with 53 approved supplements and 0 published complete response letters.

First approved: Feb 27, 1981
Review: Standard
Supplements approved: 53
Complete response letters: 0

What It's For

From the FDA-approved label (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 54 submissions below


Oct 25, 1991	Supplement 11Efficacy (new indication or use)	Approved	None posted
Oct 25, 1991	Supplement 22Efficacy (new indication or use)	Approved	None posted
Feb 27, 1981	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Restoril15MG · capsule;oral	Temazepam	RxReference drug
Restoril30MG · capsule;oral	Temazepam	RxReference drug
Restoril7.5MG · capsule;oral	Temazepam	RxReference drug
Restoril22.5MG · capsule;oral	Temazepam	RxReference drug

All 54 submissions, including labeling and manufacturing supplements


Jan 13, 2023	Supplement 71Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 5, 2021	Supplement 67Labeling	Approved	Label Letter
Feb 6, 2019	Supplement 65Labeling	Approved	Letter Label
Dec 16, 2016	Supplement 64Labeling	Approved	Letter Label
Nov 8, 2010	Supplement 54Labeling · Standard review	Approved	Label Letter
Feb 25, 2008	Supplement 59Labeling · Standard review	Approved	Letter Label
Feb 25, 2008	Supplement 58Labeling · Standard review	Approved	Letter Label
Nov 2, 2004	Supplement 57Manufacturing · Standard review	Approved	Letter
May 31, 2002	Supplement 53Labeling · Standard review	Approved	Letter
Apr 11, 2000	Supplement 48Labeling · Standard review	Approved	None posted
Apr 11, 2000	Supplement 32Labeling	Approved	None posted
Oct 27, 1999	Supplement 52Manufacturing · Standard review	Approved	None posted
Apr 15, 1999	Supplement 51Manufacturing · Standard review	Approved	None posted
Dec 18, 1995	Supplement 49Manufacturing · Standard review	Approved	None posted
Dec 7, 1995	Supplement 50Manufacturing · Standard review	Approved	None posted
Feb 27, 1995	Supplement 46Manufacturing · Standard review	Approved	None posted
Dec 13, 1994	Supplement 47Manufacturing · Standard review	Approved	None posted
Jul 19, 1994	Supplement 29Labeling	Approved	None posted
Jul 15, 1994	Supplement 43Manufacturing · Standard review	Approved	None posted
Jul 13, 1994	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 13, 1994	Supplement 38Manufacturing · Standard review	Approved	None posted
Mar 29, 1994	Supplement 31Labeling	Approved	None posted
Mar 17, 1994	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 28, 1994	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 23, 1993	Supplement 41Manufacturing · Standard review	Approved	None posted
Jun 15, 1993	Supplement 45Manufacturing · Standard review	Approved	None posted
Apr 21, 1993	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 2, 1993	Supplement 44Labeling · Standard review	Approved	None posted
Nov 25, 1992	Supplement 42Labeling · Standard review	Approved	None posted
Aug 10, 1992	Supplement 40Labeling	Approved	None posted
Apr 16, 1992	Supplement 37Labeling	Approved	None posted
Apr 15, 1992	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 25, 1991	Supplement 11Efficacy (new indication or use)	Approved	None posted
Oct 25, 1991	Supplement 22Efficacy (new indication or use)	Approved	None posted
Mar 14, 1990	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 16, 1990	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 16, 1990	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 22, 1990	Supplement 25Labeling	Approved	None posted
Jan 22, 1990	Supplement 23Labeling	Approved	None posted
Jun 28, 1989	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 2, 1987	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 10, 1987	Supplement 20Labeling	Approved	None posted
Apr 9, 1987	Supplement 19Manufacturing · Standard review	Approved	None posted
May 16, 1986	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 22, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 22, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 22, 1985	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 11, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 25, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 25, 1982	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 26, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
May 12, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
May 12, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 27, 1981	Original applicationNew molecular entity · Standard review	Approved	None posted

Show all 54

Identifiers

Application: NDA 18163
Drugs@FDA: Overview at FDA
Company: SpecGx

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters