Can Lasmiditan cause somnolence?

ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment [see Warnings and Precautions ( 5.1 )] Central Nervous System Depression [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Medication Overuse Headache [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW. In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200 mg [see Clinical Studies ( 14.1 )] . Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity. The mean age at study entry was 42.4 years (range 18 to 81). Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12 months in a long-term safety study. Of these, 728 patients were exposed to 100 mg or 200 mg for at least 3 months, 361 patients were exposed to these doses for at least 6 months, and 180 patients were exposed to these doses for at least 12 months, all of whom treated at least 2 migraine attacks per month on average. In that study, 14% (148 out of 1,039) in the 200 mg dose group, and 11% (112 out of 991) in the 100 mg dose group withdrew from the trial because of an adverse event. The most common adverse event resulting in discontinuation in the long-term safety study (greater than 2%) was dizziness. Table 1 shows adverse reactions that occurred in at least 2% of patients treated with REYVOW and more frequently than in patients who received placebo in Studies 1 and 2. The most common adverse reactions (at least 5%) were dizziness, fatigue, paresthesia, and sedation. Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2 a Fatigue includes the adverse reaction related terms asthenia and malaise. b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral. c Sedation includes the adverse reaction related term somnolence. Adverse Reaction REYVOW 50 mg N=654 % REYVOW 100 mg N=1265 % REYVOW 200 mg N=1258 % Placebo N=1262 % Dizziness 9 15 17 3 Fatigue a 4 5 6 1 Paresthesia b 3 7 9 2 Sedation c 6 6 7 2 Nausea and/or Vomiting 3 4 4 2 Muscle Weakness 1 1 2 0 Less Common Adverse Reactions The following adverse reactions occurred in less than 2% of REYVOW-treated patients but more frequently than in patients receiving placebo: vertigo, incoordination, lethargy, visual impairment, feeling abnormal, feeling hot or feeling cold, palpitations, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, muscle spasm, limb discomfort, cognitive changes, confusion, euphoric mood, chest discomfort, speech abnormalities, dyspnea, and hallucinations. Hypersensitivity Events of hypersensitivity, including angioedema, rash and photosensitivity reaction, occurred in patients treated with REYVOW. In controlled trials, hypersensitivity was reported in 0.2% of patients treated with REYVOW compared to no patients who received placebo. If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and discontinue administration of REYVOW. Vital Sign Changes Heart Rate Decrease REYVOW was associated with mean decreases in heart rate of 5 to 10 beats per minute (bpm) while placebo was associated with mean decreases of 2 to 5 bpm. Consider evaluating heart rate after administration of REYVOW in patients for whom these changes may not be tolerated, including patients taking other medications that lower heart rate [see Drug Interactions ( 7.3 )] . Blood Pressure Increase REYVOW may increase blood pressure following a single dose. In non-elderly healthy volunteers there was a mean increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of up to 1 mm Hg for placebo. In healthy volunteers over 65 years of age, there was a mean increase from baseline in ambulatory systolic blood pressure of 7 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of 4 mm Hg for placebo. By 2 hours, there were no increases in mean blood pressure with REYVOW compared to placebo. REYVOW has not been well studied in patients with ischemic heart disease. Consider evaluating blood pressure after administration of REYVOW in patients for whom these changes may not be tolerated.

WARNINGS AND PRECAUTIONS Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. ( 5.1 ) Central Nervous System (CNS) Depression: REYVOW may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants. ( 5.2 , 7.1 ) Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with REYVOW. Discontinue REYVOW if symptoms of serotonin syndrome occur. ( 5.3 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.4 ) 5.1 Driving Impairment REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mg doses of REYVOW significantly impaired subjects' ability to drive [see Clinical Studies ( 14.2 )] . Additionally, more sleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not to engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or operating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. 5.2 Central Nervous System Depression REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation [see Adverse Reactions ( 6.1 )] . Because of the potential for REYVOW to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and driving impairment, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants [see Drug Interactions ( 7.1 )] . Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken [see Warnings and Precautions ( 5.1 )] . 5.3 Serotonin Syndrome In clinical trials, reactions consistent with serotonin syndrome were reported in patients treated with REYVOW who were not taking any other drugs associated with serotonin syndrome. Serotonin syndrome may also occur with REYVOW during coadministration with serotonergic drugs [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia, incoordination), and/or gastrointestinal signs and symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue REYVOW if serotonin syndrome is suspected. 5.4 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamines, triptans, opioids, or a combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (i.e., medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.