Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

EDLUAR (NDA-021997)

(ZOLPIDEM TARTRATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/18/2019 (SUPPL-11)

Approved Drug Label (PDF)

Boxed Warning

Newly added section:

WARNING: COMPLEX SLEEP BEHAVIORS

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior.

4 Contraindications

Addition of the following:

who have experienced complex sleep behaviors after taking Edluar

5 Warnings and Precautions

Newly added subsection:

5.1 Complex Sleep Behaviors

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of zolpidem. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants. Discontinue Edluar immediately if a patient experiences a complex sleep behavior.

6 Adverse Reactions

Newly added to the bulleted line listing:

Complex Sleep Behaviors

7 Drug Interactions

7.1 CNS-active Drugs

Addition of the following heading:

CNS Depressants

Co-administration of zolpidem with other CNS depressants …

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

Edluar may cause serious side effects, including:

Complex sleep behaviors that have caused serious injury and death. After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with Edluar whether or not you drink alcohol or take other medicines that make you sleepy.

Stop taking Edluar and call your healthcare provider right away if you find out that you have done any of the above activities after taking Edluar.

Do not take Edluar if you:

have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone, or having sex) while not being fully awake after taking Edluar.

PATIENT COUNSELING INFORMATION

Newly added information:

Complex Sleep Behaviors

Instruct patients and their families that Edluar may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue Edluar and notify their healthcare provider immediately if they develop any of these symptoms.

02/06/2019 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 CNS Depressant Effects and Next-Day Impairment

(additions underlined)

…

Because Edluar can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

(additions underlined)

…

CNS-depressant Effects and Next-Day Impairment

Tell patients that Edluar has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.

…

10/24/2018 (SUPPL-8)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

PLLR conversion; extensive changes; please refer to label for complete information.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

What should I tell my healthcare provider before taking Edluar?

Edluar may not be right for you. Before starting Edluar, tell your healthcare provider about all of your health conditions, including if you:

are pregnant or planning to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take Edluar.
using Edluar in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual), trouble breathing, or limpness in the newborn if Edluar is taken late in pregnancy.

PATIENT COUNSELING INFORMATION

Newly added information:

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Edluar. Advise patients that use of Edluar late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used Edluar during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness.

Lactation

Advise breastfeeding mothers using Edluar to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after Edluar administration to minimize drug exposure to a breastfed infant.