Can Addyi (flibanserin) cause sedation?

Sedation Effects of Addyi (Flibanserin)

Yes, Addyi (flibanserin) can cause sedation, which is listed as one of its most common adverse reactions (somnolence). 1

Sedative Properties of Flibanserin

• Somnolence (drowsiness/sleepiness) is among the most common adverse reactions of Addyi, occurring in ≥2% of patients taking the medication 1
• Central Nervous System (CNS) depression, including somnolence and sedation, can occur with Addyi alone and may be exacerbated by other CNS depressants 1
• The FDA label specifically warns about the sedative effects, noting that patients should avoid activities requiring full alertness (such as operating machinery or driving) until at least six hours after each dose 1

Timing of Administration and Sedation

• Addyi is specifically dosed at bedtime because administration during waking hours increases the risks of sedation, CNS depression, and related adverse effects 1
• The recommended dosage is 100 mg taken once daily at bedtime to minimize the impact of sedative effects during waking hours 1
• Morning dosing of flibanserin (as used in some studies) is inconsistent with the bedtime dosing recommended in clinical practice 2

Clinical Significance of Sedation

• In clinical trials, drowsiness was identified as one of the most common minor adverse effects of flibanserin 3
• The sedative effects of flibanserin are well-documented and considered in its safety profile 4
• Like other medications with sedative properties, the CNS depression effects can be enhanced when combined with other substances that cause sedation 1

Precautions Related to Sedation

• Patients taking Addyi should be cautioned about the potential for sedation and advised to avoid activities requiring full alertness until they know how the medication affects them 1
• The sedative effects may be more pronounced when Addyi is combined with:
  • Alcohol (which is contraindicated with Addyi) 1
  • Other CNS depressants 1
  • Moderate or strong CYP3A4 inhibitors (contraindicated) 1
• Patients with pre-syncope (which can be related to sedation) should immediately lie down and seek medical help if symptoms don't resolve 1

Managing Sedation Risk

• Bedtime dosing is specifically recommended to minimize the impact of sedation during waking hours 1
• Patients should wait at least six hours after taking Addyi before engaging in activities requiring full alertness 1
• Avoiding alcohol is essential, as it can exacerbate the sedative effects of flibanserin 1
• Patients should be monitored for signs of excessive sedation, especially when starting the medication 4

The sedative properties of Addyi are significant enough to warrant specific warnings in the FDA label and influence its recommended administration time. Understanding these effects is crucial for appropriate patient counseling and safe use of the medication.