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.

INTERMEZZO (NDA-022328)

(ZOLPIDEM TARTRATE)

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

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08/18/2019 (SUPPL-8)

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 INTERMEZZO. Some of these events may result in serious injuries, including death. Discontinue INTERMEZZO immediately if a patient experiences a complex sleep behavior.

4 Contraindications

Newly added information:

INTERMEZZO is contraindicated in patients who have experienced complex sleep behaviors after taking INTERMEZZO.

5 Warnings and Precautions

Newly added subsection:

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 INTERMEZZO immediately if a patient experiences a complex sleep behavior.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Complex Sleep Behaviors

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

MEDICATION GUIDE

Additions and/or revisions underlined:

INTERMEZZO may cause serious side effects, including:

Complex sleep behaviors that have caused serious injury and death. After taking INTERMEZZO, 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 INTERMEZZO whether or not you drink alcohol or take other medicines that make you sleepy.

Stop taking INTERMEZZO and call your healthcare provider …

Important:

Do not take INTERMEZZO 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 fully awake) after taking Intermezzo.

Who should not take INTERMEZZO?

Do not take INTERMEZZO if you have ever had a complex sleep behavior happen after taking INTERMEZZO.

PATIENT COUNSELING INFORMATION

Newly added:

Complex Sleep Behaviors

Instruct patients and their families that INTERMEZZO 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 INTERMEZZO and notify their healthcare provider immediately if they develop any of these symptoms.

02/06/2019 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 CNS Depressant Effects and Next-Day Impairment

(additions underlined)

…

Because Intermezzo can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at a 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 Intermezzo 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 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness. Advise patients the increased drowsiness and decreased consciousness may increase the risk of falls in some patients.

…