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When using this medication, it is crucial to be aware of several important safety considerations. Below are key warnings and precautions to keep in mind:

• Abnormal Sleep Behaviors: This medication may lead to unusual activities while not fully awake, such as sleepwalking, driving, eating, making phone calls, or engaging in sexual activities. There is often no recollection of these events, which can pose significant risks, including potential injury or fatality. The risk increases when combined with alcohol or other sleep-inducing drugs, but these behaviors can occur even when taking the medication as directed. If you or someone else observes you engaging in these activities, discontinue use immediately and consult your healthcare provider to discuss alternative treatments.

• Daytime Sleepiness and Reduced Alertness: The medication can result in daytime drowsiness, confusion, dizziness, and slowed mental function. These effects may be exacerbated by alcohol or other medications like benzodiazepines, opioids, or tricyclic antidepressants. If you are taking other medications that cause drowsiness, inform your healthcare provider, as you may need a dosage adjustment.

• Severe Allergic Reactions: In rare cases, this drug can cause a severe allergic reaction, such as swelling of the tongue, lips, throat, or mouth (angioedema), and symptoms like difficulty breathing, nausea, or vomiting. These reactions can occur at any point during treatment and may be life-threatening. Seek emergency medical help immediately if you experience these symptoms.

• Behavioral Changes and Mood Alterations: The medication can lead to changes in thoughts and behaviors, including aggression, agitation, or hallucinations. If you notice any significant behavioral changes, inform your healthcare provider for further evaluation. This risk is heightened if you have a history of depression or suicidal thoughts.

• Respiratory Concerns: The drug may cause slowed breathing, particularly in individuals with sleep apnea. If you experience changes in your breathing, contact your healthcare provider as you may need to switch to a different medication.

• Liver Considerations: For those with liver conditions, the medication may not be processed effectively, increasing the risk of side effects. It is especially risky for individuals with severe liver problems as it can lead to brain damage (encephalopathy). Disclose any liver issues to your healthcare provider before beginning treatment.

• Withdrawal Symptoms: Long-term use can lead to dependency, and abrupt cessation or dose reduction may result in withdrawal symptoms like nausea, vomiting, tremors, panic attacks, and muscle cramps. If you experience these, consult your healthcare provider.

• Contraindications: Avoid using this medication if you've previously experienced abnormal sleep behaviors after taking it, such as sleepwalking or sleep driving.

Always consult your healthcare provider for personalized advice and guidance when taking this medication, especially if you have additional health concerns or are taking other medications.

Common side effects:

• headaches
• sleepiness
• dizziness
• diarrhea

Less common but important to monitor:

• nausea
• dry mouth
• back pain
• flu-like symptoms
• chest pain
• feelings of tiredness
• loss of energy
• lightheadedness
• depression
• abnormal dreams
• memory loss
• stomach pain
• constipation
• sinus infection
• sore throat
• rash

Serious side effects:

• dangerous sleep behaviors like sleepwalking or sleep driving
• slowed brain activity leading to excessive sleepiness or confusion
• respiratory issues such as shallow or slow breathing
• severe allergic reaction including hives, shortness of breath, chest tightness, or swelling of the lips, tongue, face, or eyes
• suicidal thoughts or behaviors

Interactions with high risk of serious adverse effects and should be avoided:

• Sodium Oxybate
• Opioid pain relievers (e.g., codeine, hydrocodone)
• Alcohol
• Marijuana (cannabis)
• Sleep or anxiety medications (e.g., Alprazolam, Lorazepam, zopiclone)
• Muscle relaxants (e.g., Carisoprodol, Cyclobenzaprine)
• Antihistamines (e.g., Cetirizine, diphenhydramine)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Azole antifungals (such as Ketoconazole)
• Rifampin
• St. John's Wort